Proprietary drug name approval: taking the duel out of the dual agency process.
ABC Inc., a global pharmaceutical company, is in the midst of Phase II clinical trials (1) for a drug product now named HI123456. The company executives are told by the Research and Development division that HI123456 will be a revolutionary treatment in the war against Hodgkin Lymphoma Disease. (2) Now that the Phase II results show that the drug is very promising, the product team will enlist marketing to begin the process of creating branding for the new drug. While HI123456 still has to go through Phase III clinical trials, the product team must think ahead and ensure that a proprietary drug name is not only created, but approved for the product, well before the projected launch to market, which can be as little as two years away. Thus, the battle for approval of the potential proprietary drug name for HI123456 begins.
The story of HI123456, while fictional, is the story of many drugs in the pipeline (3) today in the United States. At this stage, market launch seems highly likely. However, teams associated with the drug are well aware that a misstep in the approval process for a proprietary drug name can delay or even halt the launch of the drug to market. The approval process for the proprietary drug name can be both complex and vexing. Two separate governmental agencies oversee the process using entirely different analyses and operate on wholly different timeframes. The agencies who take on the role of approving potential proprietary drug names are the United States Patent and Trademark Office ("USPTO") and the Food and Drug Administration ("FDA"). While there are very distinct reasons why the review processes at each agency are different, the process, particularly at the FDA, has been hindered in such a way that it has resulted in high costs for the pharmaceutical industry and delays in access to life-saving drugs for patients. Unless addressed, the current problems with the review process will continue to persist. Ultimately, the key to improving the proprietary drug name approval process is to correct the problems at the FDA and align both agencies for the sake of efficiency.
As a drug begins to head down the pipeline toward the marketplace, it straddles two hemispheres of the world of intellectual property. In one hemisphere, it has a patentable component which consists of its chemical makeup. (4) In the other hemisphere, there is a proprietary component also known as its brand name, the part that can be trademarked. (5) This name is extremely important because it becomes the way the consumer identifies the compound, its source, and the manner in which the compound is marketed. For the pharmaceutical industry, which is always in search of the next blockbuster drug, the proprietary name is invaluable. (6) Therefore, it comes as no surprise that the resources and money that contribute to finding a proprietary drug name are quite substantial. (7)
The USPTO will determine whether the potential proprietary drug name is registrable such that it can be used in commerce. In addition, the FDA will determine whether the potential proprietary drug name is acceptable such that it can be used on the packaging, labeling, and in advertising for different reasons. This bifurcated process often results in a potential drug name gaining registration at the USPTO, only to then be rejected by the FDA after an elongated process. (8) Without a positive result from both agencies, the potential drug name is rendered useless. While the USPTO's standards have been transparent, conversely, the FDA's standards have historically been vague and inconsistent. (9) Moreover, FDA has rejected potential proprietary drug names at an alarmingly high rate with no instructive guidance to the drug sponsor such that the sponsor could understand why the name was rejected or whether the sponsor could appeal. (10) The FDA needs to create a standard, similar to USPTO's standard, furthering transparency in all facets of the review process.
A major step toward changing the proprietary drug name approval process at the FDA came in the form of legislation embodied in the 2007 amendments to the Prescription Drug User Fee Act (PDUFA IV). (11) The Act included targeted performance goals for the FDA that encompassed reducing medication errors attributed to, but not limited to, look-alike and sound-alike drug names. (12) These performance goals had a direct correlation with the proprietary drug name approval process at the FDA. For the first time, the FDA engaged stakeholders in the pharmaceutical industry to improve the proprietary drug name review process and through this dialogue, started to develop a system of transparency which began to give real insight into the process and provided meaningful information to stakeholders. For instance, this dialogue led to stakeholders learning how to avoid potential areas of concern and thus possible rejection of their name candidates. (13) Despite this positive step forward, the Act has not been without its critics. Many patient advocacy groups have voiced concerns that a faster approval process is not a safer approval process. (14) Moreover, there have been questions as to whether the FDA can maintain its independence in light of the influence from the pharmaceutical industry. (15) Notwithstanding these concerns, this comment argues that the engagement between the FDA and the pharmaceutical industry by virtue of the Act must serve as a stepping stone toward meaningful change in the proprietary drug name review process.
To provide an overview, Part II of this comment will compare and contrast the review processes at the USPTO and the FDA. Part III will briefly discuss the historical implementation of the Prescription Drug User Fee Act ("PDUFA") of 1992 and its role in reshaping the FDA's mandates. Additionally, Part III will discuss the 2007 amendment of PDUFA (aka as PDUFA IV), its relationship to the proprietary drug name review process, and the Act's effect on the FDA in its review process. Lastly, Part IV recommends reforms to the FDA and integration of the two agencies.
II. THE DUAL APPROVAL PROCESS
To grasp the complexities of the dual agency approval process, an overview of how the USPTO and the FDA make a determination as to whether a potential proprietary drug name should or should not gain approval is appropriate. While there is an overlap in the processes of both agencies, each process has its own unique requirements in place to serve the agency's purpose, which is mandated by statute. This section serves to briefly describe the process of each agency.
A. THE TRADEMARK PROCESS
A trademark is any word, name, symbol, or device, or any combination thereof, that is used by a person or entity to distinguish and identify their goods or services to the public at large. (16) The USPTO is the agency that oversees the registration of trademarks. The agency is granted its authority to review and register trademarks through the Lanham Act. (17) In the United States, rights in a trademark are established through first use of the trademark in commerce. (18) This is because trademark law is an outgrowth of the broader law of unfair competition. (19) While federal registration of a trademark is not required to use a trademark in commerce, the registration affords the trademark owner certain protections against others should anyone try to infringe upon the rights of the owner. (20) These protections are of particular importance in the pharmaceutical industry because the counterfeiting of "famous" drugs can cost a pharmaceutical company billions of dollars in sales (21) and even more importantly endanger the lives of consumers who purchase the counterfeit products. (22) Without the protections afforded by federal registration of the trademark associated with the drug, the pharmaceutical company's potential for redress is more difficult. (23)
Generally, an applicant can utilize one of five potential bases for filing an application with the USPTO for registration of its proposed trademark. (24) Most frequently, applicants file their applications based upon use in commerce or Intent-to-use. (25) The use-based application can be filed when the applicant has already started to use the proposed mark in commerce in connection with the proposed goods and/or services. (26) The intent-to-use application is filed when the applicant has a genuine and "bona fide" intention to use the mark in commerce and signs a declaration to that effect in the application. (27) Since it is highly unlikely that a pharmaceutical product has gained approval from the FDA prior to filing a trademark application, pharmaceutical applicants usually file on an intent-to-use basis. (28)
Typically, the pharmaceutical applicant will attempt to time the filing of an application for a potential proprietary drug name to align with the potential launch of the product in the consumer market and Phase II of the clinical trial process. (29) However, even before the application is filed, a proprietary drug name will go through an extensive pre-filing search process to determine the proposed name's likelihood of registrability. Any applicant can perform such a search in order to make a determination as to the availability of the proposed drug name because the Lanham Act explicitly states the prohibitions to registration. (30) Moreover, the USPTO recommends that an applicant perform a pre-filing search to determine whether anyone claims the rights to the applicant's potential name. (31) For the large pharmaceutical company, this pre-filing process will likely entail hiring a sophisticated branding company to create potentialproprietary drug names and hiring outside counsel to conduct the clearance. (32) Generally, this process will continue until the applicant identifies a few viable candidates for filing with the USPTO. More than one potential drug name will be filed to ensure that if the applicant's first choice is rejected, either at the USPTO or FDA, there is a back-up choice readily available.
Once the applicant has filed the application, an examining attorney will be assigned to review the application. (33) This specialized attorney will determine whether the mark is sufficiently distinctive and its likelihood of causing confusion among consumers. (34) The guidelines for substantive review of a trademark application are set forth in the Trademark Manual of Examining Procedure (TMEP). (35) Since the major thrust of the Lanham Act is to grant rights and protection to the owner of a federally registered trademark, the "likelihood of confusion" analysis is paramount to the review. (36) The test for "likelihood of confusion" considers such factors as:
1. the similarity or dissimilarity of the marks in their entireties as to appearance, sound, connotation and commercial impression;
2. the similarity or dissimilarity and nature of the goods or services as described in an application or registration or in connection with which a prior mark is in use;
3. the similarity or dissimilarity of established, likely-to-continue trade channels;
4. the sophistication of the buyers; and
5. the extent of potential confusion, i.e., whether de minimis or substantial. (37)
As it pertains to potential proprietary drug names and, due to the USPTO's acknowledgement that pharmaceutical products have consumer safety issues, the level of scrutiny can be narrowed under a "doctrine of greater care" standard. (38) The prudent proprietary drug name applicant will be mindful of this and avoid applying for potential drug names which could be confusingly similar to consumers.
Barring the previously mentioned substantive issues, the application will be published for opposition by the USPTO. (39) The opposition period, which customarily lasts thirty days, allows for any third party to object to the application. (40) If no opposition is filed, the USPTO will issue a Notice of Allowance which puts the applicant on notice that he or she has a certain amount of time to provide evidence of use in commerce. (41) If a drug applicant is in the late stages of clinical trials and is using the mark, the applicant can submit to the USPTO the labeling that is used on the actual containers during the trials. (42) Ultimately, if the evidence of use is determined to be sufficient, the application will be approved for registration. The average pendency of a trademark application from filing to registration is thirteen months. (43) This is just the first hurdle that the proprietary drug name has to overcome. The second hurdle, and usually the last, is regulatory approval from the FDA.
B. THE FDA PROCESS
The Federal Food, Drug, and Cosmetic Act (the "FD&C Act") grants the FDA authority to mandate that all new drugs will be subject to approval before being commercialized in the United States. (44) Unlike federal trademark registration, an optional process, FDA approval for a proprietary drug name is mandatory. Without approval from the FDA, the proprietary drug name cannot be used and thus the drug cannot be introduced into commerce. The agency's task in the proprietary drug name approval process is to ensure that no drug name receives approval if its use on the drug's labeling is false or misleading. (45) A potential proprietary drug name can be misleading if the drug name implies a certain composition, alludes to a unique effectiveness or may be confused with the proprietary name or established name (46) of another drug or ingredient. (47) Additionally, it may be considered misleading if the potential proprietary drug name includes part of the name of an ingredient that makes up the new drug's composition. (48)
Another contrast to the USPTO is that the FDA's focus is patient safety while the USPTO's focus is consumer confusion as to the product's source in the marketplace. (49) Specifically, the agency must determine whether there is a potential safety or health risk based on the proprietary drug name candidate's likelihood to be confused with other drug names. (50) The FDA effectuates this review by using a look-alike/sound-alike approach. (51) While some overlap occurs in the confusion analyses of both agencies, the FDA's review is geared toward the reduction of medication errors (52) at all points in which the medication can be used. (53) This includes procuring, prescribing and ordering, dispensing, administering and monitoring the effects of the medications. (54) The FDA does not simply focus on the consumer's confusion but also focuses on the health care provider or pharmacist's ability to become confused.
While a trademark application can be filed at the USPTO on an intent-to-use basis, an application for review of the proposed proprietary name cannot be submitted to the FDA by a drug applicant until the compound has undergone a thorough series of clinical testing. (55) Once completed, the drug name applicant will submit an application for review with two potential proprietary drug names in order of preference. (56) In terms of timing, the FDA takes the approach that the first potential drug name to gain approval has priority over another potential drug name that was filed before it. This is in stark contrast to the USPTO which takes the approach that the first to file has priority over subsequent applications. (57)
Specific branches of the FDA will oversee different aspects of the proprietary drug name review process. Through the Center for Drug Evaluation and Research (CDER), a review is conducted by the Division of Medication Error Prevention and Analysis (DMEPA) in consultation with the Division of Drug Marketing, Advertising and Communications (DDMAC) to determine the acceptability of the proposed proprietary name. (58) The DMEPA conducts the safety review. (59) The process entails reviewing the spelling of the proposed proprietary name, its pronunciation, and how it may appear if handwritten in a prescription as compared with other existing and proposed proprietary names. (60) This is achieved through various testing methodologies.
One such method is the Failure Mode and Effects Analysis (FMEA) which is a systematic method to examine the nomenclature of a product for possible ways in which an error or failure could occur once a list of potentially similar names has been developed. (61) As stated earlier in this comment, since drug confusion can occur at any point in the medication use process, DMEPA will consider confusion at the point of procuring, prescribing and ordering, dispensing, administering and monitoring the impact of the medication. (62)
Other testing methodologies utilize databases to determine the safety of the proprietary drug name. One such database is the Phonetic and Orthographic Computer Analysis database (POCA). POCA will run the name through its database using an algorithm which will provide a percentage score between the proposed name and existing proprietary names. (63) It also will consider similar strengths and dosage forms. (64) A score of 100% suggests an identical match to an existing drug name which would prove to be fatal to the proposed proprietary name. The DDMAC (65) will conduct a promotional review of the proposed proprietary drug name. Its function is to determine whether the proposed proprietary name is overly fanciful in such a way as to overstate the compound's efficacy. (66)
Additionally, DDMAC tries to determine whether drug confusion risks are minimized, whether the promotion extends the product's indications, or makes unsubstantiated claims of superiority. (67) Should the first proposed drug name fail either the testing by DDMAC or DMEPA, (68) the second proposed drug name undergoes review for the same drug. (69) The second proposed name submitted will not undergo review unless the first choice falls. (70) If the potential drug name is found to be safe and not misleading by both the DDMAC and the DMEPA, the FDA will grant its approval to be used on labeling and in advertising. However, this approval is discretionary given that the FDA can request changes to labeling and advertising after the drug has launched if it finds that there is misleading information or information that may cause a safety risk. (71) Currently, the FDA reports a median review time of thirteen months for a New Drug Application (NDA) or a Biologics Licensing Application (BLA). (72)
As illustrated above, the USPTO and the FDA take very different approaches to reviewing the potential proprietary drug name. Despite these differences, the one constant in both approaches is the "confusion" analysis. This confusion analysis should be the basis for collaboration between the agencies. However, before there can be collaboration, the FDA has to refine its procedures and address its funding and staffing issues. The 2007 amendments to the Prescription Drug User Act (also known as PDUFA IV) has addressed some of these problems, but more can be done. On the other hand, the Trademark Office of USPTO has become a model agency in terms of consistency and predictability of outcomes and review times. (73) However, if the agency were to enhance its review of potential proprietary drug names, its review would be a threshold inquiry into the viability of the drug name. If rejected at the USPTO, there would be no need to file for approval at the FDA. Therefore, it stands to reason that the agencies should look to each other to determine how they can make the process for approval of proprietary drug names transparent, predictable, and timely.
III. THE FDA AND THE ENACTMENT OF THE PRESCRIPTION DRUG USER FEE ACT (PDUFA)
As previously stated, ridding the FDA of its inefficiencies and defects is the key to the improvement of the overall process. PDUFA and its subsequent reauthorizations have aided in remediating some of the agency's problems. Before attempting to understand the significance of the PDUFA IV amendments of 2007 and their effect upon the proprietary drug name review process, one should first understand how and why Congress enacted the Prescription Drug User Fee Act (PDUFA) of 1992. (74)
Prior to the early 1990s, a drug could conceivably take more than a decade to move from discovery to commercialization in the United States. (75) This timing resulted in large part from the expansion of the FDA's role in not only regulating new human drugs prior to their launching to market but also from the FDA's expansion in many other areas as a result of the agency's general mission to ensure the safety and efficacy of the nation's food supply, medical devices, and biological products. (76) However, the
timing had detrimental effects on the pharmaceutical industry and the public. For the pharmaceutical industry, the delays caused potential drug sponsors to lose precious time in market exclusivity after gaining patent registration. (77) In order to realize some profits, pharmaceutical firms opted to first launch their products abroad where approval times were much shorter. (78) For patients, the delays meant that they would not have access to potentially life-saving drugs, which in some cases meant the difference between life and death. (79) Unfortunately, in these respects, the FDA's significant staffing and funding deficiencies resulted in untimely reviews of drug applications. (80)
In 1992, after much pressure from the pharmaceutical industry and the public, Congress enacted the Prescription Drug User Fee Act (also known as PDUFA I) as a more efficient way to facilitate the approval of new drugs. (81) Essentially, PDUFA I authorized the FDA to collect fees from drug sponsors to augment appropriated funding from Congress* Interestingly, because the pharmaceutical industry had concerns that the funds would be used for other purposes, they were slow to embrace the idea of paying fees in prior years. (82) Similarly, the FDA initially had concerns that the collection of fees from pharmaceutical companies might give the public perception that the agency would not be truly independent* However, in light of the costs of both economic and human loss, a consensus was formed between Congress, the FDA, and the pharmaceutical industry. With the enactment of PDUFA, Congress provided the FDA with a new revenue stream explicitly earmarked for new product review and established performance goals with specific targets for review times. (83) Moreover, the new revenue stream provided much needed funds to hire additional staffing. PDUFA was reauthorized three more times in 1997, 2002 and 2007. (84) Each reauthorization increased the threshold for fee collection by the FDA. (85) The new fees also came with new and additional constraints on how the funds could be allocated. (86) The 2007 reauthorization, PDUFA IV, addressed the proprietary drug name process for the first time.
A. PDUFA IV AND THE PROPRIETARY DRUG NAME REVIEW PROCESS
PDUFA was re-authorized in 2007 (PDUFA IV) with the signing into law of the Food and Drug Administration Amendments Act of 2007. (87) Under PDUFA IV, the FDA committed to a number of performance goals including the utilization of fees to reduce medication errors related to look-alike and sound-alike proprietary names, unclear label abbreviations, acronyms, designations, and error-prone label and packaging designs. (88) This was the first time that the FDA squarely focused on the proprietary drug name review process. Specifically, the FDA agreed to increase consistent and timely review of proposed proprietary names to prevent confusion. (89) As part of that overarching goal, the FDA committed to implement a pilot program that allowed participants in the pharmaceutical industry to evaluate their potential names and submit the data to the FDA for review. (90) Additionally, the FDA agreed to provide the pharmaceutical industry with a guidance paper on what a complete submission for evaluation of a proprietary name should entail as well as information on internal review procedures. (91) Together, these goals were viewed by the pharmaceutical industry as a welcomed improvement since they could potentially provide some predictability in the process.
B. THE PDUFA IV PILOT PROJECT PROPRIETARY NAME REVIEW
As mentioned above, one of the PDUFA IV performance goals charged the FDA with the task of creating and implementing a pilot program for the pharmaceutical industry to participate in the evaluation of a potential proprietary drug name. The impetus for the program was the realization that a proprietary drug name plays a large part in the medication error problem. (92) For example, the brand name drug, LOSEC[R] (93) (omeprazole for the treatment of stomach ulcers and other gastrointestinal conditions), was changed at the FDA's request because it was being confused with the brand name drug, LASIX[R] (94) (frusemide is a diuretic used to reduce swelling and fluid retention associated primarily with heart disease), primarily through prescription error. (95) This confusion proved to be fatal given the different indications for each medication in some instances and ultimately, LOSEC[R] was renamed PRILOSEC[R]. (96) With an eye towards reducing medication errors like the LOSEC/LASIX problem, the program was developed to enable pharmaceutical manufacturers to conduct proprietary name reviews of their potential drug names and submit the data generated to the FDA as part of a two-part evaluation. (97)
To successfully implement this goal, the FDA held a technical meeting to discuss the planned pilot with the pharmaceutical industry and other important stakeholders to determine the logistics of the program and any concerns. (98) This initial meeting and subsequent discussions gave rise to a concept paper that would describe the pilot to potential candidates. (99) After this time, the FDA set a goal to begin enrollment to the pilot program by the end of 2009 and called for an evaluation of the pilot program by the end of 2011 to determine the program's feasibility. Presently, the FDA is staying on track with the plan to implement the pilot program. In June of 2008, the technical meeting was held to introduce the program and solicit comments from the public and the pharmaceutical industry. (100) In September of 2008, the FDA developed and publicly released a concept paper, which delineated the logistics of the program and suggested different methodologies that should be employed when preparing to evaluate a potential proprietary drug name. (101) Lastly, a notice to enroll in the program was issued on October 1, 2009. (102)
To participate in the pilot program, an applicant seeking review of its proprietary drug name must first register with the FDA to ensure that the agency can anticipate how to allocate the workload. (103) In its registration request, the applicant is expected to provide a proposed date for submission of the application. (104) If the date is acceptable, the FDA will confirm the date and the applicant submits the application within the first two business days of the month agreed upon. (105) All applicants participating m the program must make a dual submission so that the application is reviewed under the pilot by one reviewer and under the traditional method by another reviewer. (106) At the end of the review process, both reviewers will come together and discuss the contents and outcomes of their respective reviews in order to make a final determination about the proposed proprietary name. (107)
The program is voluntary and the FDA's goal is to receive twenty-five to fifty submissions from a cross-section of different companies in the industry over a two year period. (108) After the two year period is completed, the FDA will make an assessment to determine whether it is feasible to have pharmaceutical companies evaluating their potential drug names before submission to the agency as opposed to having the agency conduct de novo reviews of proprietary drug names. (109)
C. THE ISSUANCE OF THE FDA's GUIDANCE FOR INDUSTRY
In February of 2010, the FDA issued its guidance paper to the industry with recommendations on how an application should be prepared for submission to the FDA. The FDA revealed how it may assess whether the proposed drug name is safe and whether all aspects of the promotional materials are not misleading and in compliance with the FDA's requirements. (110) To the extent that this guidance paper was offered to provide more transparency to the process, it still had a prominent defect. In particular, it explicitly stressed that it neither described the methods used for evaluation of proposed proprietary names using the traditional review process, nor the information needed to evaluate proposed proprietary names under the voluntary pilot program. (111) Perhaps this was to relieve the FDA of any liability should a name be rejected using the recommendations issued in the guidance paper.
Nevertheless, the guidance paper provided background information which showed the link between medication errors and proprietary name selection within the medication use system. (112) Specifically, the paper provided a detailed approach which illustrated how the FDA evaluates proposed proprietary names; namely, how the agency performs a safety and promotional evaluation on a proposed drug name. (113) Finally, the paper described recommendations of what should be included in an application to be considered complete for purposes of review. (114) The submission of a complete application is critical in order to trigger the timing for review. (115) Under the PDUFA IV performance goals, the review time will start based upon the date of receipt of the proposed proprietary name submission. (116) Depending on the type of application filed, the review must be completed and tentative acceptance or denial must be communicated to the applicant within 90 or 180 days of the receipt of a complete submission. (117)
IV. PDUFA IV--ENHANCEMENT OR HINDRANCE OF THE PROPRIETARY DRUG NAME PROCESS
As a result of the enactment of PDUFA IV and the commitments that must be met for the FDA to utilize the user fees, the agency has improved its processes for review and become more transparent. However, with each reauthorization of PDUFA, there are two main complaints, agency independence and funding. This section will discuss the positive and negative impact of PDUFA IV on the proprietary drug name process.
A. THE POSITIVE--QUICKER REVIEW OF PROPRIETARY NAME APPLICATIONS AND GUIDANCE
Under PDUFA IV, the FDA committed to certain review time goals starting in 2009 through 2011. During this time period, the FDA is expected to notify drug applicants of tentative acceptances or denials (non-acceptance) within 90 days for name submitted with New Drug Application ("NDA") or Biologic License Application ("BLA") applications and 180 days for proprietary names submitted during the Investigational New Drug ("IND") phase. (118) It was determined that there would be no goal for 2008. (119) In 2009, the performance level was set at 50% on time notification for submissions, for 2010 the goal was set at 70% and for 2011 and 2012 the goal was set at 90%. (120) According to reports submitted to the President and Congress, the FDA exceeded its commitment for 2009 and 2010. At the time of the reporting for 2009, out of the 61 proprietary names submitted during the Investigational New Drug phase in 2009, the agency achieved a 97% on-time rating. (121) Only one application was overdue. (122) For the 187 proprietary drug names submitted with NDA or BLA applications, the agency achieved an 87% on-time rating. (123) There were 18 applications that were overdue during the same period. (124) Similar positive news was reported for 2010. Out of 101 proprietary names submitted during the IND phase, there was a 92% on-time rating. (125) For proprietary names submitted with NDA or BLA applications, the on-time rating was 93%. (126)
In terms of management initiatives, the FDA hit all three of its goals as it pertains to proprietary names. The agency timely published draft guidance to the industry in November 2008, it began tracking and reporting goal performance, it published the final concept paper describing the pilot program on October 7, 2008 and in September 2009, the agency published information regarding the pilot programs logistics. (127) All of these goals were met because of the ability of the FDA to use PDUFA IV revenues to ensure that the necessary staff was hired and available to review the applications in a timely manner. (128) If one were solely to focus on the superficial numbers, it would appear that PDUFA IV is a success. However, the scope of the PDUFA IV should not be so narrowly construed.
B. THE NEGATIVE--THE WOES OF FASTER DELIVERY, INDEPENDENCE, FUNDING AND A PILOT PROGRAM
1. FASTER DELIVERY, INDEPENDENCE AND FUNDING
To be sure, PDUFA, since its inception, has improved the approval times of new drug applications. (129) Notwithstanding the improvement, one of the main criticisms voiced by governmental officials and consumer and patient advocacy groups is that faster has not proven to be better. (130) This argument has some veracity as evidenced by the string of drug withdrawals that occurred from 1997 and culminated with what has been described as the biggest FDA approval debacle, VIOXX[R], which was voluntarily withdrawn by its maker in 2004. (131) The premise is and has been that the pharmaceutical industry is so entrenched in the agency due to PDUFA, that agency officials rushed drugs to market despite concerns from their own safety personnel. (132) The critics focus on the fact that this time span overlaps with the time span that PDUFA has been enacted and reauthorized. (133) Armed with a study by the New England Journal of Medicine, the critics assert that PDUFA induced the agency to inappropriately approve drugs that caused many deaths before they were withdrawn. In fact, it has been estimated that somewhere between 88,000 to 139,000 Americans suffered a heart attack or stroke taking VIOXX[R]. (134) The drugs LOTRONEX[R], PROPULSID[R], REZULIN[R], RAXAR[R], POSICOR[R], DURACT[R] and REDUX[R] were suspected of causing 1002 deaths collectively before withdrawn from the market. (135)
The repercussions of drug approvals are still being felt; however, the more objective stance is that the blame is equally spread between the agency's post-marketing monitoring failures and the pharmaceutical companies' aggressive practices at the expense of patient safety. The gap in the agency's ability to ensure the public's safety has a direct correlation with funding. Specifically, it was not until PDUFA III where the focus shifted from heavily funding pre-market approval to ensuring that postmarket activities became equally as important. (136) However, the bigger issue is that PDUFA was never meant to supplant appropriations and yet in 2008, user fees were estimated to contribute to 48.4% of the drug program's budget. (137) With this staggering percentage, it seems impossible for the agency to escape the perception of being "captured" by the pharmaceutical industry as the fees and performance goals are directly correlated.
2. A PILOT PROGRAM
The pilot program has been touted as a way in which the pharmaceutical industry and the agency could work together to improve efficiency at the agency and provide transparency in the process. (138) However, concerns that were broached at the technical meeting in June of 2008, prior to the implementation of the program, continue to exist and have not been adequately addressed by the agency. (139) Specifically, the industry expressed real concern over the concept of having two different reviewers evaluating the application for the pilot and the traditional review process. Whether the FDA has implemented, for purposes of consistency, a standardized procedure to resolve the differences in outcomes remains unclear. (140) Additionally, if both reviewers reject the proposed proprietary drug name under the pilot program, a question exists whether a dual rejection would set a precedent that would put that particular applicant at a disadvantage in the future. (141) Moreover, would a rejection present a complete bar to the proposed name without hope of an appeal? Given the high stakes in making a submission, many in the pharmaceutical industry may take a wait-and-see approach to the pilot until they are able to gather information as to how the pilot is progressing. (142)
Another issue which is very relevant to the user fees is the costs associated with performing all of the clearance work before submission to the FDA for the pilot. The FDA indicated that it wanted a broad cross-section of the pharmaceutical industry to participate in the program. However, the work entailed in testing a proprietary name for submission to the FDA could cost well into the hundreds of thousands of dollars. (143) While these projected substantial costs may more easily be written off by a large pharmaceutical company, such as the size of a Novartis AG or Pfizer Inc., a smaller research based firm might be financially disadvantaged to engage in the type of screening required under the pilot. As such, the cross-section of pharmaceutical companies that the FDA desires may not be feasible particularly when the pilot is voluntary. Without a cross-section of companies, the FDA cannot accurately assess the outcomes of the program.
On the other hand, the pilot program presents an opportunity for the FDA to increase efficiency by having drug sponsors do the lion-share of the work as it relates to evaluating the safety and promotional aspects of a proposed mark. This program would allow the agency to free up valuable human resources so that personnel would no longer have to engage in such a detailed evaluation anew but the evaluation process would be more of a confirmatory process of work already done. As the process stands, it would really be no different from how the pharmaceutical industry currently conducts its clinical trials. (144) That being said, there are gold standards in place to conduct testing in the pre-clinical and clinical trial phases of investigation into the safety and efficacy of a drug. (145) For the proprietary name review process, the gold standard has yet to be established. A two year trial with a guidance paper that is not meant to be binding will not provide the necessary information the FDA may be seeking to establish a new review paradigm. The time has come to develop that gold standard.
When one considers the gaps in the agency's goals for the pilot program along with its determination that it will not provide any information about the program until after the pilot has been completed, one wonders whether proceeding with the program was feasible. More generally, and as it pertains to proprietary drug name review, many of the goals and programs to be instituted under PDUFA IV were not implemented until 2009 leaving a mere three years until the expiry date in 2012. As such, it is still too early to say how PDUFA IV will ultimately affect the process.
V. PATHWAYS TO REFORM
A. AGENCY COOPERATION
Given the distinct purposes of the USPTO and the FDA for reviewing a proprietary drug name, the reasoning for why two agencies are involved in the review process is understandable. In a perfect world, one might think that simply combining both agencies would solve all the problems in the proprietary drug name process. However, the problems that could evolve as a result of full integration of both agencies would surpass the most complex merger in United States history. Moreover, the result would be an unyielding agency with entirely too many roles. A simpler path is integration of USPTO and FDA personnel through the creation of a special joint commission for the sole purpose of reviewing proprietary drug names.
This commission would respect the differences in the confusion analysis by honing the expertise of both agencies to focus on all aspects of the likelihood of confusion analysis as it relates to consumer confusion in the marketplace as well as conduct a safety and promotional evaluation. To conduct these reviews, the commission would be staffed with specialized attorneys and healthcare professionals namely doctors, nurses, and pharmacists who together would create review panels for each potential proprietary drug name application submitted. The examining attorneys who are already trained to evaluate a trademark application using the traditional guidance as set forth in the Trademark Manual of Examining Procedure (TMEP), would heighten the confusion analysis as it relates to medications. (146) This review should entail look-alike/sound-alike analysis as well as an analysis of the description of goods. (147) The safety and promotional analysis would be conducted by health professionals who would leverage their experience at the FDA to evaluate all aspects of the potential drug name and how it could conceivably cause medication errors. Crucial to the health professionals' analysis would be the creation of a standardized evaluation procedure similar to the Trademark Office's TMEP. This would bring some predictability to the process which has been lacking for some time.
Under the auspices of the proposed joint commission, a potential drug name applicant submits its application for review. As with current mandates to eliminate paper submissions, the application would be filed electronically. (148) A complete application would include all the component parts of a trademark application and as well as the component parts of a submission for review of a proprietary drug name for FDA approval. (149) Similar to the way in which drug sponsors submit the results of their clinical trials, the drug sponsor would now be required to submit all investigational studies which analyzed the potential of safety risks. The investigational studies would be comprised of specific testing and methodologies that the agency would require the drug sponsor to use in their investigative process. These guidelines could change as dictated by technology and advancements in the healthcare system over time. This would cut down on the need for personnel requirements and create efficiency at the newly formed commission.
Upon assigning an application to a panel comprised of FDA and USPTO professionals, the review process would begin with the analysis on whether there are any bars to trademark registration. If the trademark evaluation passes the opposition phase, the FDA professionals would begin the safety and promotional analysis. The filing date of the application will govern the priority of an application. This would mark a significant change from the FDA's first approved policy. It would eliminate such complications as the possibility that a drug sponsor would need to negotiate with an owner of an application that was junior to their trademark application but gained approval at the FDA before the more senior drug name. Conversely, this modification would eliminate a drug sponsor who has gained approval first at the FDA, and then having to negotiate with the owner of a trademark registration or prior filed application in order to use the potential proprietary drug name.
Should the trademark evaluation prove fatal to the application, the safety and promotional evaluation would not commence. Ultimately, the goal would be that the joint commission's approval times do not extend the process but improve upon the approval times when the agencies were separate. (150) The proposed joint commission would have to work together to develop realistic time-frames so that, barfing substantive issues, the pendency rate of an application would be an improvement on current timeframes of the separate agencies. Collaboration between the two agencies on a small scale will go a long way to streamlining the process and making it easier for the pharmaceutical industry to develop a greater understanding and respect for the process.
Even if the above recommendation is stalled, the agencies should, at a minimum, consider setting up a joint advisory committee. (151) Federal advisory committees have been established for a number of different issues, most notably the establishment of the Department of Homeland Security. (152) Germane to the discussion here, advisory committees are governed by the Federal Advisory Committee Act which mandates certain structural and operational requirements so that there is accountability and transparency. (153) As such, the committee could not simply be established and subsequently fail to make real progress.
While there is no "apples to apples" comparison on point, there is a recent collaboration between the Securities Exchange Commission ("SEC") and the U.S. Commodities Futures Trading Commission ("CFTC") that can serve as a model for the USPTO and FDA. (154) Similar to the USPTO's and FDA's role in the proprietary drug name review process, both the SEC and CFTC have distinct but similar roles to play in regulating the financial markets. (155) As a result of the recent financial crisis and realization that each agency's markets were so interdependent and intertwined, the SEC and CFTC held unprecedented joint meetings to hear from academics, industry experts, and the investment community. (156) Upon a comprehensive examination of the SEC's and CFTC's regulatory regimes, the joint effort acknowledged that there are distinct reasons for the differences between the agencies. However, the agencies had some shared common objectives that they could use as the basis for collaboration. (157) Thus, recommendations were designed to fill regulatory gaps, eliminate inconsistent oversight and promote greater collaboration. (158) One of the recommendations that came to fruition is the CFTC-SEC Joint Advisory Committee. (159) The committee has taken an active role in considering and developing solutions to emerging and ongoing issues of common interest. (160)
Likewise, the FDA and USPTO can do the same. A joint advisory committee can review the regulatory framework of each agency, the role that each plays in the proprietary drug name process, determine where each agency aligns and make recommendations, where feasible, toward fostering collaboration and efficiency in the process. Attempting to predict the result of such a committee is speculative. At best, a comprehensive review from a variety of those involved in the process will lead to real reform and collaboration, and at worst, will lead to a greater appreciation of each agency by the other in their respective roles in the proprietary drug name review process. Given the importance of the proprietary drug name review process and the complex role that both the USPTO and FDA have in that process, it would be prudent to create such an advisory committee, as proposed here, that is comprised of members of each agency, the public sector and the pharmaceutical industry.
B. FUNDING AND AGENCY INDEPENDENCE
Unlike the USPTO, the current system of funding in place at the FDA relies heavily upon user fees as prescribed by PDUFA. (161) As stated earlier, user fees made up a significant part of the human drug program. While PDUFA is already in its fourth reauthorization and conceivably will have a fifth reauthorization, the agency should find a way to exist without user fees. Currently, the USPTO's budget is based significantly upon congressional appropriations and funds collected through filing fees. The FDA should shift to a similar funding structure. This would require filing fees which would provide revenue for the application process and the remainder of the funding should be appropriated by Congress* While some may contend that there would not be an appreciable difference from the current user fee system, the distinct difference would be that the pharmaceutical industry would no longer dictate how the money should be allocated* Further, the FDA would once again be able to determine where the funds would be best allocated.
While there is no doubt that PDUFA in many ways put the FDA on the path towards reform, the time has come to move away from this system to restore the agency's independence. Moreover, even in today's time of budget cutting, Congress must find a way to properly fund the agency that has one of the most important mandates: protecting the health of the nation. By reducing the revenue stream created by PDUFA, the agency moves away from the current dynamic which has the very industry that the FDA is supposed to police, essentially supporting it. Also, proper funding would eliminate the disparity of the large pharmaceutical companies having an advantage over smaller companies in terms of possible influence and lobbying power.
C. STANDARDIZATION OF THE PROPRIETARY DRUG NAME PROCESS AT THE FDA
The long-standing and continual complaint from the pharmaceutical industry has been that the FDA has not been transparent and therefore, the pharmaceutical industry has no actual idea as to how the agency evaluates a proprietary drug name. However, the publication of Guidance for Industry by the FDA in February of 2010 finally provided a look into the evaluation process the FDA undertakes. This recognition is progress, but it is not enough. As one commentator recommended, the guidance needs to be codified or adopted in the Code of Federal Regulations like the Trademark Manual of Examining Procedure (TMEP). (162) If the agency were to officially adopt guidelines for the review process, all interested parties would have a reference work to use when evaluating potential proprietary names. The process would go from being a subjective one that lacks predictability to an objective process upon which the pharmaceutical industry and the agency could rely. (163) Similar to the examiners of the Trademark Office, the examiners for the FDA would be subject to the applicable statutes and any notices or rules issued by the Commissioner of the agency. Moreover, the manual can be revised to accommodate technological advances which could enhance the process.
With the FDA's continuing and expansive role in trying to ensure the safety of the public by minimizing medication errors, the pharmaceutical industry's investment in creating a fanciful drug name that is globally acceptable and the USPTO's mandate to ensure the rights of prior mark owners, there is no doubt that the complexities of the proprietary drug name process will continue to grow. Both agencies must have a hand in the process to ensure the public safety and protect the intellectual property ownership rights. For the FDA, the efficiencies that have been fostered by PDUFA IV will hopefully be the springboard to additional reforms in the agency's proprietary drug name evaluation process. On the top of a potential list of reforms must be the creation of a gold standard for the review process. Additionally, Congress must act to support the agency by appropriating proper funding commensurate with its mission of protecting the nation's health. Moreover, to do so would bring the agency out from under the cloud of industry influence. For the Trademark Office, collaboration could mean a heightened and more strategic review of potential drug names which can eliminate the need for submissions at the FDA. All in all, the proprietary drug name review process must be reformed for the sake of efficiency, transparency, and public safety. That reform needs to occur, and will only be successful through a collaborative effort between the agencies.
APPENDIX A DRUG DEVELOPMENT TIMELINE Pre- Approval Post- clinical Clinical 1-2-2 marketing 1-6 years 5-7 years years Ongoing Discovery IND * Phase I NDA * or --Continued Clinical safety data on --Testing application testing BLA * the drug and conducted filed filed names are in vitro (small scale collected and in Efficacy and animals safety --Changes to studies in generic or healthy trade name humans) require large-scale Phase II education of clinical health care testing professionals, approval (small scale from the FDA efficacy and safety studies in patients) Phase III clinical testing (large scale efficacy and safety studies in patients) Proprietary Proprietary drug name drug name is applications submitted filed with with the FDA the USPTO along with (late in NDABLA ** Phase II) * IND--Investigational New Drug application filed with the FDA to obtain permission to conduct clinical studies. * NDA--New Drug Application-application to request permission/approval to market the drug in the USA. * BLA--Biologics Licensing Application--application to request permission/approval to market the drug in the USA. ** FDA will give approval of proprietary drug name in this phase. *** Information assembled from various charts illustrating drug development in the pipeline. See Drug Development Stages, GOGGLE IMAGES, http://www.google.com/images?hl=en&source= hp&biw=1276&bih=563&q=drug+development+stages&gbv=2&aq=2&aqi=g 10&aql=&oq=drug +development (last visited Apr.9, 2011). APPENDIX B FY 2009 SUBMISSIONS Submission Performance Type level Received Proprietary Act on 50 61 names percent within submitted 180 days of during IND receipt phase Proprietary Act on 50 187 names percent within submitted 90 days of with receipt NDABLA Performance as of September 30, 2009 Submission Type Percent On-time Overdue on time Pending * Proprietary 35 1 97% 25 names submitted during IND phase Proprietary 125 18 87% 44 names submitted with NDABLA * Pending includes only those notification commitments that have been acted on and are not overdue. FY 2010 SUBMISSIONS Submission Performance Type level Received Proprietary Act on 70 101 names percent within submitted 180 days of during IND receipt phase Proprietary Act on 70 204 names percent within submitted 90 days of with receipt NDABLA Performance as of September 30, 2010 Submission Type Percent On-time Overdue time Pending * on Proprietary 49 4 92% 48 names submitted during IND phase Proprietary 163 13 93% 28 names submitted with NDABLA * Pending includes only those notification commitments that have been acted on and are not overdue. ** The above information was extracted from the FY 2009 and FY 2010 performance reports. See FISCAL YEAR 2009, supra note 89; FISCAL YEAR 2010, supra note 25.
(1.) Generally, clinical trials are considered to be biomedical or health-related research studies in human beings that follow a specific protocol so as to determine the efficacy and safety of the drug or device for use in humans. See Understanding Clinical Trials, U.S. NAT'L INSTITUTES OF HEALTH, http://clinicaltrials.gov/ ct2/info/understand#Q01 (last visited Feb. 3, 2011).
(2.) Lymphoma is a type of blood cancer which starts in the lymphatic system. The lymphatic system is part of the body's immune system which assists the body in fighting off infection. Hodgkin lymphoma is distinguished from other lymphomas by presence of certain type of cells called Reed-Steinberg cells (named for the scientist who discovered them). See Hodgkin Lymphoma, THE LEUKEMIA & LYMPHOMA SOCIETY, http://www.leukemia-lymphoma.org/ all_page?item_id=7085 (last visited Feb. 4, 2011).
(3.) Common industry term used to describe the products that a drug company has in research and development process.
(4.) See What is a Patent?, U.S. PATENT AND TRADEMARK OFFICE, http://www.uspto.gov/ web/offices/pac/doc/general/#patent (last visited Jan. 31, 2010) (providing general information regarding patents).
(5.) See What is a Trademark or Servicemark?, U. S. PATENT AND TRADEMARK OFFICE, http://www.uspto.gov/web/ offices/pac/doc/general/#patent (last visited Jan. 31, 2010) (providing general information regarding trademarks).
(6.) See Dana M. Herberholz, Curing Confusion:An Overview of the Regulatory Complexities of Obtaining Pharmaceutical Trademark and a Prescription for Reform, 8 MINN. J. L. SCI. & TECH. 97, 122 ("the proprietary name is an unsleeping salesman that ceaselessly promotes the product and therefore, should pack as much recognition and recall value as possible" (quoting from a presentation given on behalf of The Brand Institute)); James L. Dettore & Patricia K. Staub, Benefits of a Strategic Pharmaceutical Branding, BRAND INSTITUTE (Sept. 28, 2001), http://www.brandinstitute.com/ NEWS/FOCUS_12_01.HTM.
(7.) According to the Tufts Center for the Study of Drag Development, it costs on average more than $1 billion dollars to take a new drag from clinical trials to market in the United States. See Drug Companies Still Under Pressure to Increase Pace of Development, TUFTS CTR. FOR THE STUDY OF DRUG DEVELOPMENT (Jan. 6, 2010), http://csdd.tufts.edu/news/complete_story/pr_outlook_2010.
(8.) See SUSAN THAUL, CONG. RESEARCH SERV., RL33914, THE PRESCRIPTION DRUG USER FEE ACT (PDUFA): BACKGROUND AND ISSUES FOR PDUFA IV REAUTHORIZATION 1 (2007) [hereinafter PDUFA IV].
(9.) See Herberholz, supra note 6, at 123-24 (suggesting that if there was an examining procedure which provides a framework as to how a potential proprietary name were reviewed on par with the Trademark Office's Trademark Manual of Examination Procedures ("TMEP"), the process would be more transparent for the pharmaceutical industry).
(10.) FDA 101: Medication Errors, U.S. FOOD AND DRUG ADMIN. (Feb. 20, 2009), http://www.fda.gov/ForConsumers/ConsumerUpdates/uem048644.htm.
(11.) 21 U.S.C. [section] 379(g)-(h) (2006 & Supp. 2009).
(12.) PDUFA Pilot Project Proprietary Name Review Concept Paper, U.S. FOOD AND DRUG ADMIN. (Sept. 2008) [hereinafter Concept Paper], http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm072229.pdf.
(14.) See SUSAN THAUL, CONG. RESEARCH SERV., RL33914, THE PRESCRIPTION DRUG USER FEE ACT (PDUFA): HISTORY, REAUTHORIZATION IN 2007, AND EFFECT ON FDA 8-9 (2008) [hereinafter PDUFA HISTORY].
(16.) 35 U.S.C. [section] 2(a)-(b), 15 U.S.C. [section] 1127 (2006).
(18.) United Drug Co. v. Theodore Rectanus Co., 248 U.S. 90, 97 (1918) ("[t]here is no such thing as property in a trade-mark except as a right appurtenant to an established business or trade in connection with which the mark is employed"); see also Hanover Milling Co. v. Metcalf, 240 U.S. 403, 415(1913) ("[T]he exclusive right to the use of a trade-mark is founded on priority of appropriation.").
(19.) See Moseley v. Victoria Secret Catalogue, Inc., 537 U.S. 418, 428 (2003).
(20.) As a general matter, those rights include: prima facie evidence of the validity of the registration, the ownership of the mark and the owner's exclusive rights to use the mark in commerce in connection with the services or goods; constructive notice of ownership in the mark; the right to file in federal court despite the lack of diversity; and the fight to damages, profits and attorneys fees. See 15 U.S.C. [section][section] 1057(b)and (c), 1072, 1117, 1121 (2006).
(21.) In 2008, it was estimated that the counterfeiting of VIAGRA[R] caused losses of $2 billion per year to Pfizer Inc. See International Enforcement of Intellectual Property Rights and American Competiveness, Hearing Before the Senate Finance Committee (2008) (statement of Jeff Kindler Chairman and CEO, Pfizer, Inc.), available at http://www.pfizer.com/files/news/ kindler_testimony_sfc_071508.pdf.
(22.) In some cases, the counterfeit products do not contain the active ingredient or worse yet, they contain ingredients that can cause death. For instance, in 2006 there were 365 deaths in Panama due to children unknowingly ingesting diethylene glycol (a toxic component of antifreeze) that was substituted for glycerin by the counterfeiters. Additionally, in 2005 U.S. consumers were alerted to a recall of counterfeit LIPITOR[R] which was sold in the United Kingdom. See Press Release, United States Food and Drug Administration, FDA Warns Consumers About Counterfeit Drugs from Multiple Internet Sellers (May 1, 2007), http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/2007/ucm108904.htm; see also, Press Release, United States Food and Drug Administration, FDA Alerts U.S. Residents to Recall of Counterfeit "Lipitor" Sold in the United Kingdom (July 29, 2005), http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/2005/ucm108469.htm.
(23.) The federal registration of a trademark is presumptive of ownership and the rights that inure. See 15 U.S.C. [section][section] 1057(b)-(e), 1072, 1117, 1121(2006). By gaining federal registration of their trademark, a pharmaceutical drug company may be entitled to have the counterfeit goods, the documents, and the equipment of counterfeiters immediately seized. Moreover, the counterfeiters can become subject to criminal sanctions, which is outside the scope of this comment. See Adam Powell, Benchmark Legislation: A Measured Approach in the Fight Against Counterfeit Pharmaceuticals, 61 HASTINGS L.J. 749, 756-58 (2009) (Ironically, the penalties for counterfeit drugs without trademark infringement carries a light penalty resulting in little or no jail time. However, manufacture and sale of illegal drugs will result in ten to fifteen years in prison.).
(24.) An applicant can file a trademark application based upon intent-to-use, use or international conventions whereby the United States is obligated to recognize the filing dates or registrations of trademarks filed abroad (Madrid Protocol, Pan-American Convention, Paris Convention); see 15 U.S.C. [section][section] 1051(a)-(b), 1126(d)-(e)(2006).
(25.) See PERFORMANCE AND ACCOUNTABILITY REPORT FISCAL YEAR 2010, U.S. TRADEMARK AND PATENT OFFICE, http://www.uspto.gov/about/stratplan/ar/2010/USPTOFY2010PAR.pdf [hereafter FISCAL YEAR 2010].
(26.) See 37 C.F.R. [section] 2.34(a)(1) (2010).
(27.) See id. [section] 2.34(a)(2).
(28.) All subsequent discussion focuses on the intent-to-use application.
(29.) See Drug Name Development Timeline and USAN Review Procedure, AM. MED. ASS'N, http://www.ama-assn.org/ama/pub/physician-resources/ medical-science/united-states-adoptednames-council/ drug-name-development-timeline-usan-review.shtml (last visited Jan. 28, 2011).
(30.) The statute states in relevant part:
No trademark by which the goods of the applicant may be distinguished from the goods of others shall be refused registration on the principal register on account of its nature unless it:
(a) Consists of or comprises immoral, deceptive or scandalous matter....
(b) Consists of or comprises the flag or coat of arms or other insignia of the United States, or of any State or municipality, or of any foreign nation, or any simulation thereof.
(c) Consists of or comprises a name, portrait, or signature identifying a particular living individual except by his written consent, or the name, signature, or portrait of a deceased President of the United States during the life of his widow, if any, except by the written consent of the widow.
(d) Consists of or comprises a mark which so resembles a mark registered in the Patent and Trademark Office, or a mark or trade name previously used in the United States by another and not abandoned, as to be likely when used on or in connection with the goods of the applicant, to cause confusion, or to cause mistake, or to deceive.
15 U.S.C. [section] 1052(a)-(d) (2006).
(31.) Start Here .for First Time Filers, U.S. PATENT AND TRADEMARK OFFICE (2011), http://www.usptu.gov/trademarks/basics/index.jsp.
(32.) Companies like The Brand Institute and Interbrand Wood offer name development services to companies who seek to find fanciful names for their drug product. See Name Development Services, THE BRAND INSTITUTE, http://www.brandinstitute.com/services_namedevelopment.asp (last visited Jan. 31, 2011); see also Prozac, INTERBRAND WOOD, http://www.interbrand.com/en/ our-work/Eli-Lilly-Prozac.aspx (last visited Feb. 10, 2011).
(33.) As a general matter, a trademark is filed with the USPTO in connection with specific goods and/or services. A description must be drafted for the application that conforms to the Trademark Acceptable Goods and Services Manual. The manual provides a classification system for every potential good or services. Pharmaceutical products fall under Class Heading "5." See The Trademark Acceptable Goods and Services Manual, U.S. PATENT AND TRADEMARK OFFICE, http://tess2.uspto.gov/netacgi/nph-brs?sect2=THESOFF§3=PLURON&s1= pharmaceutical+preparations+&l=MAX§1 =IDMLICON§4=HITOFF&op1=AND&d= TIDM&p=1&u=%2Fnetahtml%2Ftidm.html&r=0&f=S (last visited Jan. 31, 2011).
(34.) 15 U.S.C. [section] 1062(a)-(b) (2006).
(35.) TRADEMARK MANUAL OF EXAMINING PROCEDURE (7th ed. 2010), available at http://tess2.uspto.gov/tmdb/tmep/. The TMEP is the manual that provides guidelines and procedures that examining attorneys are authorized and required to follow when examining applications.
(36.) The statute states, in pertinent part,
the intent of this Act is to regulate commerce within the control of Congress by making actionable the deceptive and misleading use of marks in such commerce; to protect registered marks used in such commerce from interference by State, or territorial legislation; to protect persons engaged in such commerce against unfair competition; to prevent fraud and deception in such commerce by the use of reproductions, copies, counterfeits, or colorable imitations of registered marks; and to provide rights and remedies stipulated by treaties and conventions respecting trademarks, trade names, and unfair competition entered into between the United States and foreign nations.
15 U.S.C. [section] 1127 (2006); see also K.P. Permanent Make-up Inc. v. Lasting Impressions, Inc., 408 F.2d 596, 608 (2005) ("[l]ikelihood of confusion exists when consumers viewing the mark would probably assume that the goods it represents are associated with the source of a different product identified by a similar mark") (citation omitted).
(37.) These factors are known as the Dupont Factors. See In re E.I. Du Pont de Nemours & Co., 476 F.2d 1357, 1361 (C.C.P.A. 1973).
(38.) Glenwood Labs., Inc. v. Am. Home Prod. Corp., 455 F.2d 1384, 1387 (C.C.P.A. 1972).
(39.) 15 U.S.C. [section][section] 1062-63 (2006) (holding that the likelihood of confusion between the marks in light of the fact that the goods were medicinal products could result in harm to the public).
(40.) 15 U.S.C. [section] 1063 (2006).
(41.) 37 C.F.R. [section] 2.81 (2010).
(42.) G.D. Searle & Co. v. Nutrapharm, Inc., No. 98-6890, 1999 US Dist LEXIS 16862, at *810 (S.D.N.Y. Oct. 29, 1999) (stating that shipping a drug product to an investigator during clinical trials with labeling which includes the potential proprietary name constitutes use in the pharmaceutical context).
(43.) FISCAL YEAR 2010, supra note 25, at 24.
(44.) The history and origin of the FDA date back to 1906 with the passage of the Pure Food and Drugs Act. Its modern day functions evolved with the subsequent passing of the Food, Drug and Cosmetic Act of 1938 in the wake of a sulfur drug disaster which killed 100 people in 1937. John P. Swann, FDA Origin, FDA HISTORY OFFICE (June 18, 2009), http://www.fda.gov/ AboutFDA/WhatWeDo/History/Origin/ucm124403.htm.
(45.) 21 U.S.C. [section][section] 352(a), 355(d)(7) (2006 & Supp. 2008); 21 C.F.R. [section][section] 314.105(c), 314.125(b)(6), 314.125(b)(8) (2010).
(46.) An established name is also known as a compound's generic name. This name is not used commercially and is created by the United States Adopted Names Council (USANC). The purpose of the USANC is to serve the health professions in the United States by selecting simple, informative, and unique nonproprietary names for drugs by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships. The USANC is tri-sponsored by the American Medical Association (AMA), the United States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA). For more information regarding the generic naming process visit the American Medical Association website. United States Adopted Names, AM. MED. ASS'N, http://www.ama-assn.org/ama/pub/physician-resources/ medical-science/united-states-adopted-names-council.shtml (last visited Apr. 9, 2011).
(47.) 21 C.F.R. [section] 210.10(b)-(c) (2010); see also Danielle A. Gentin, You Say Zantac, I Say Xanax: A Critique of Drug Trademark Approval and Proposals for Reform, 55 FOOD & DRUG L.J. 255, 260 (For instance, the story of the hair-restoration drug, minoxidil's road to market is illustrative of how a proposed proprietary drug name can be considered to allude to a unique effectiveness. Originally, Pharmacia & Upjohn planned to market the drug under the proprietary name, REGAIN, which gained registration at the USPTO. However, the FDA did not approve the mark because it suggested the drug would re-grow hair. Ultimately, the FDA approved use of ROGAINE[R].).
(48.) Id. For instance, the active ingredient in the drug CLARITIN[R] is loratadine. If the manufacturer attempted to name the drug LORATIN which uses the LORA prefix of loratadine, it is highly likely that the name would be rejected by the FDA.
(51.) How FDA Reviews Proposed Drug Names, U.S. FOOD AND DRUG ADMIN. (2009) [hereinafter How FDA Reviews Proposed Drug Names], http://www.fda.gov/downloads/Drugs/DrugSafety/Medication Errors/ucm080867.pdf.
(52.) A medication error is defined as
any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.
About Medication Errors, NAT'L COORDINATING COUNCIL FOR MEDICATION ERROR REPORTING AND PREVENTION (2011 ), http://www.nccmerp.org/aboutMedErrors.html.
(53.) Committee on Identifying and Preventing Medication Errors, QUALITY CHASM SERIES 4349 (Philip Aspden, Julie Wolcott, J. Lyle Bootman, Linda R. Cronenwett, eds. 2007).
(55.) Heberholz, supra note 6, at 106. Pre-clinical testing includes laboratory and animal testing for purposes of making a preliminary safety determination. Clinical testing includes human trials.
(56.) This procedural step allows the FDA to have an alternative immediately ready for review in the event the first choice fails to gain approval. Review of the second choice does not commence unless the first choice fails.
(57.) It should be noted that prior applications have priority and serve as a bar to subsequent applications. Moreover, the first to file system allows an application to have priority over subsequent filings. With a first to approval system such as the FDA's system, order of filing becomes irrelevant. See 15 U.S.C. [section][section] 1057(c), 1141f(b) (2006).
(58.) How FDA Reviews Proposed Drug Names, supra note 51.
(59.) Id. at 2.
(61.) Guidance for Industry. Contents of a Complete Submission for Evaluation of Proprietary Names, U.S. FOOD AND DRUG ADMIN. 5 (Feb. 2010) [hereinafter Guidance for Industry], http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UC M075068.pdf; see also Institute of Healthcare Improvement, IHI.ORG (2011), http://www.ihi.org/1HI/Topics/PatientSafety/ MedicationSystems/Tools/Failure+Modes+and+Effects+Analysis+FME A+Comparison+of+Five+Medication+Dispensing+Scenarios+IHI+Tool.htm.
(62.) Aspden, supra note 53, at 49 (describing the medication use process).
(63.) How FDA Reviews Proposed Drug Names, supra note 51.
(65.) Division of Drug Marketing, Advertising and Communications.
(66.) How FDA Reviews Proposed Drug Names, supra note 51.
(68.) Division of Medication Error Prevention and Analysis.
(69.) Guidance for Industry, supra note 61, at 9.
(71.) See 21 U.S.C. [section] 379(g)(6)(f) (2006 & Supp. 2008) (the statute gives the FDA authority to monitor post-market activities related to the product). The FDA has the authority to require a Risk Evaluation and Mitigation Strategy upon receipt of new safety information. See Memorandum of Agreement Between the Office of New Drugs and the Office of Surveillance and Epidemiology in the Ctr. for Drug Evaluation and Research (June 16, 2009), http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafety InformationforPatientsandProviders/ucm111350.htm.
(72.) PDUFA HISTORY, supra note 14, at 8 tbl.1. The table shows the decline in the median approval time from twenty-seven (27) months in 1993 to thirteen (13) months in 2006. A Biologics Licensing Application (BLA) is a submission to the FDA that contains information regarding the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product. See Types of Applications, U.S. FOOD AND DRUG ADMIN., http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/default.htm (last visited Feb. 28, 2011) [hereinafter Types of Applications].
(73.) FISCAL YEAR 2010, supra note 25, at B 11.
(74.) See 21 U.S.C. [section] 379(g)-(h) (2006 & Supp. 2009). The Prescription Drug User Fee Amendments of 2007 is Title I of the Food and Drug Administration Amendments Act of 2007. See 21 U.S.C. [section] 379(h)(2) (Supp. 2009).
(75.) See James L. Zelenay, Jr., The Prescription Drug User Fee Act: Is a Faster Food and Drug Administration Always a Better Food and Drug Administration?, 60 FOOD & DRUG L.J. 261 (2005); see also Barry S. Roberts & David Z. Bodenheimer, The Drug Amendments of 1962: The Anatomy of Regulatory Failure, 1982 ARIZ. ST. L.J. 581, 586 (1982).
(76.) Particularly through the late 1980s and early 1990s, the agency's role increased significantly in response to prior failures and need for oversight to protect the public. See Significant Dates in U.S. Food and Drug Law History, U.S. FOOD AND DRUG ADMIN. (2010), http://www.fda.gov/AboutFDA/WhatWeDo/History/ Milestones/ucm128305.htm.
(77.) A patent expires twenty years from the application filing date. Exclusivity is statutorily granted and exists to balance new drug innovation with generic drug competition. 21 C.F.R. [section] 314.108 (2009).
(78.) Zelenay, supra note 75, at 274-75 (describing the complaints of the industry regarding drug approval delays prior to the implementation of PDUFA).
(79.) Id. at 273 (describing the complaints of the public regarding drug approval delays); PDUFA HISTORY, supra note 14, at 8.
(80.) PDUFA HISTORY, supra note 14, at 2.
(82.) Zelenay, supra note 75, at 275-76.
(83.) PDUFA IV, supra note 8, at 2; see also Phillip J. Hilts, Plan to Seed Approval of Drugs: Makers Would Pay Fees to U.S., N.Y. TIMES, Aug. 11, 1992, at A1. It was estimated that each one month delay costs a manufacturer ten million dollars.
(84.) See generally ERIN D. WILLIAMS, CONG. RESEARCH SERV., RS22946, U.S. FOOD AND DRUG ADMIN. (FDA): OVERVIEW AND ISSUES 7, app. A (2009) (the appendix delineates the products that the FDA is responsible for regulating solely or in a collaborative effort with another agency).
(85.) See ERIN D. WILLIAMS, SUSAN THAUL, CONG. RESEARCH SERV., RL34465, FDA AMENDMENTS ACT OF 2007 (P.L. 110-85) 4-6 (2008).
(87.) See Food and Drug Administration Amendments Act of 2007 ("FDAAA"), Pub. L. 110-85, 121 Stat. 823 (codified as amended in scattered sections of 21 U.S.C.).
(88.) See Section A. PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 Through 2012, U.S. FOOD AND DRUG ADMIN., http://www.fda.gov/ForIndustry/UserFees/ PrescriptionDrugUserFee/ucm119243.htm (last visited Apr. 9, 2011).
(89.) U.S. FOOD AND DRUG ADMIN., DEP'T OF HEALTH AND HUMAN SERV., FY 2009, PERFORMANCE REPORT TO THE PRESIDENT AND CONGRESS FOR THE PRESCRIPTION DRUG USER FEE ACT [hereinafter FISCAL YEAR 2009], http://www.fda.gov/AboutFDA/ReportsManualsForms/ Reports/UserFeeReports/PerformanceReports/PDUFA/ucm228020.htm; see also FOOD AND DRUG ADMINISTRATION ACT (PDUFA) IV-DRUG SAFETY FIVE-YEAR PLAN 2008-2012, U.S. FOOD AND DRUG ADMIN. 11 (2008) [hereinafter FIVE-YEAR PLAN], http://www.fda.gov/downloads/ForIndustry/UserFees/ PrescriptionDrugUserFee/UCM 119244.pdf.
(90.) FIVE-YEAR PLAN, supra note 89, at 12.
(91.) See id. In its Five Year Plan, the FDA agreed to publish a paper that would give specific guidance to the industry as to how they review proprietary drug names and what should be submitted to the FDA.
(92.) Id. at 3, 11.
(93.) See Omeprazole, ASTRAZENECA, http://www.astrazeneca.com/Medicines/Gastrointestinal/ Product/Losec (last visited Feb. 27, 2011). Omeprazole is the generic name for the drug LOSEC[R].
(94.) See Frusemide, PUBMED HEALTH, NAT'L CTR. FOR BIOTECHNOLOGY, http://www.ncbi.nlm. nih.gov/pubmedhealth/PMH0000791/ (last visited Feb. 27, 2011). Frusemide is the genetic name for the drug, LASIX[R].
(95.) See Jean Faber, Mohamed Azzugnuni, Silvana Di Romana, & Michel Vanhaeverbeek, Fatal Confusion between LOSEC and LASIX, THE LANCET, vol. 337 at 1286-87 (May 25, 1991), available at http://www.sciencedirect.com/ science?_ob=ArticleURL&_udi=B6T1B-49K5CX6- 49C&_user=258726&_coverDate=05%2F25%21991&_rdoc=1&_fmt= high&_orig=gateway&_origin=gateway&_sort=d&_docanchor=&view=c&ac ct=C000015481&_version=1&_urlVersion=0&_userid=258726&md5= 5e1d68f96842bcea54e7f179943f95ad&searchtype=a.
(97.) Pilot Program to Evaluate Proposed Proprietary Name Submissions; Procedures to Register for Participation and Submit Data, 73 Fed. Reg. 27,001 (May 12, 2008).
(98.) FIVE-YEAR PLAN, supra note 89, at 12.
(101.) Concept Paper, supra note 12.
(102.) Pilot Program to Evaluate Proposed Proprietary Name Submissions; Procedures to Register for Participation and Submit Data, 74 Fed. Reg. 189 (Oct. 1, 2009)--Docket No. FDA-2008-N-0281.
(107.) Concept Paper, supra note 12, at 8.
(108.) Id at 6.
(109.) Id. at 1.
(110.) Guidance for Industry, supra note 61.
(111.) Id. at 2.
(112.) Id. at 2-4.
(113.) Id. at 5-6.
(114.) Id. at 9-15.
(115.) Id. at 8-9.
(117.) Whether the application is an Investigational New Drug (IND), New Drug Application (NDA) or Biologic License Application (BLA) process determines the timing of review. An IND is an application which allows a drug sponsor to be exempt from federal laws which prevent transporting or distributing a drug product before market approval. This allows for transport or distribution in interstate commerce during investigational stages. A NDA is filed by a drug sponsor when the sponsor believes it has sufficient evidence supporting the efficacy and safety of the new drug product to support market approval. Lastly, a BLA is an application that allows a manufacturer of a biologic to sell the product so long as they obtain a license. See Types of Applications, supra note 72; see also infra app. A.
(118.) FISCAL YEAR 2009, supra note 89; see also infra app. B.
(119.) FISCAL YEAR 2009, supra note 89; see also infra app. B.
(120.) See infra app. B.
(121.) FISCAL YEAR 2009, supra note 89, at 37; see also infra app. B.
(122.) See infra app. B.
(123.) FISCAL YEAR 2009, supra note 89; see also infra app. B.
(124.) FISCAL YEAR 2009, supra note 89; see also infra app. B.
(125.) FISCAL YEAR 2010, supra note 25, at 36-37; see also infra app. B.
(126.) FISCAL YEAR 2010, supra note 25; see also infra app. B.
(127.) FISCAL YEAR 2010, supra note 25, at 43-44.
(128.) See PDUFA HISTORY, supra note 14, at 7-8 & tbl.1.
(129.) Id. at 8 tbl. 1.
(130.) Zelenay, supra note 75, at 324-25 (stating that a survey of FDA reviewers who had been with the agency for at least five years felt that the review process was worsened with the shortened review times).
(131.) See Press Release, Merck Announces Voluntary Worldwide Withdrawal of VIOXX[R] (Sept. 30, 2004), http://www.merck.com/newsroom/ vioxx/pdf/vioxx_press_release_final.pdf; see also Rena Steinzor & Margaret Clune, The Hidden Lesson of the Vioxx Fiasco: Reviving a Hollow FDA, CTR. FOR PROGRESSIVE REFORM, CPR White Paper #514 (Oct. 2005), at 24, http://www.progressivereform.org/articles/Vioxx_514.pdf.
(132.) See Zelenay, supra note 75, at 324-35; see also Press Release, Public Citizen, FDA Medical Officers Report Falling Standards Permit Dangerous Drug Approvals (Dec. 2., 1998), http://www.citizen.org/pressroom/ pressroomredirect.cfm?ID=403 (reporting that standards have been lowered to approve drugs that should not have been).
(134.) See Steinzor & Clune, supra note 131, at 1.
(135.) See Zelenay, supra note 75, at 326.
(136.) See PDUFA HISTORY, supra note 14, at 11 (stating that PDUFA III fees were allocated for both pre-clinical development and up to three years after marketing begins).
(137.) Id. at 13.
(138.) See Guidance for Industry, supra note 61, at 13 (last visited Jan. 4, 2011); see also FDA Announces Pilot Program to Evaluate Proposed Drug Name Submissions, HEALTH CARE & LIFE SCIENCES CLIENT ALERT, EPSTEIN BECKER GREEN (June 2008), at 4-5 [hereinafter Pilot Program].
(139.) See Guidance for Industry, supra note 61, at 4-5.
(141.) Pilot Program, supra note 138, at 4-5.
(142.) FDA Brand Name Review: Finding Predictability in the Process, INV1VOBLOG, http://invivoblog.blogspot.com/2008/ 06/brand-name-review-finding.html (last visited Feb. 12, 2011) (noting the reluctance on the part of Novartis to be willing to participate in the pilot because of the work burden shift and the possibility of rejection).
(143.) Most large companies can engage outside counsel or an outside searching firm to conduct detailed clearance searches. The legal fees and other fees such as the cost of a search for just one potential drug name can add up. On a regular turnaround time a search of one mark can cost $800. However, the number can easily be multiplied by ten given the number of searches a drug sponsor will have conducted. See CT CORSEARCH 2011 GUIDE PRODUCTS AND RATES (2011), available at http://www.lont.com/CTCorsearchPriceGuide/.
(144.) As a general matter, the FDA does not conduct clinical trials. The sponsor of a new drug conducts clinical trials in compliance with specific practices prescribed by the FDA and absorbs any costs associated with the clinical trials. The agency will monitor and review the findings of the clinical trials upon submission the agency. See generally Running Clinical Trials, U.S. FOOD AND DRUG ADMIN., http://www.fda.gov/ScienceResearch/ SpecialTopics/RunningClinicalTrials/ default.htm (last visited Mar. 20, 2011).
(146.) U.S. PATENT AND TRADEMARK OFFICE, TRADEMARK MANUAL OF EXAMINING PROCEDURE, Chapters [section][section] 1201-1217 (7th ed. 2010), available at http://tess2.uspto.gov/tmdb/tmep/ (last visited Mar. 20, 2011) (Chapter 1200 of the TMEP covers substantive review of applications).
(147.) The query would include whether the mark is similar phonetically and in appearance to a prior mark. Additionally, the examiner should investigate whether the intended goods are closely related or identical to prior mark. For instance, a trademark application for the mark XYZ for "pharmaceutical preparations for the treatment of migranes" is filed; however, the trademark XIZ for "pharmaceutical preparations for the treatment of high blood pressure" is already registered with Trademark Office.
(148.) Electronic Submissions Gateway, U.S. FOOD AND DRUG ADMIN., http://www.fda.gov/ ForIndustry/ElectronicSubmissionsGateway/default.htm (last visited Feb. 11, 2011).
(149.) With respect to the FDA component, the drug name applicant would use the guidance paper as a reference to ensure a complete submission. See Guidance for Industry, supra note 61.
(150.) The pendency rate for a trademark application is approximately thirteen (13) months. Under PDUFA IV, the FDA committed to notifying a drug sponsor within ninety days of submission with preliminary findings. See FISCAL YEAR 2010, supra note 25, at 24; see also FISCAL YEAR 2009, supra note 89, at 36.
(151.) Federal advisory committees are created to assist the government in solving complex issues. They are often viewed as provisional governing bodies that can circumvent bureaucratic constraints to collect information from a cross-section of stakeholders and make feasible recommendations. See WENDY R. GINSBERG, CONG. RESEARCH SERV., R40520, FEDERAL ADVISORY COMMITTEES: AN OVERVIEW, at 1 (2009), available at http://www.fas.org/sgp/crs/misc/R40520.pdf.
(153.) Federal Advisory Committee Act, 5 U.S.C. App. 2 [section][section] 1-15 (2006).
(154.) See CFTS-SEC Joint Advisory Committee, U.S. COMMODITIES FUTURES TRADING COMM'N, http://www.cftc.gov/About/CFTCCommittees/ CFTC-SECJointAdvisoryCommittee/index.htm (last visited Mar. 20, 2011).
(155.) See Mission Responsibilities, U.S. COMMODITIES FUTURES TRADING COMM'N, http://www.cftc.gov/About/MissionResponsibilities/ index.htm (last visited March 7, 2011) [hereinafter Mission Responsibilities]; see also What We Do, U.S. SECURITIES & EXCHANGE COMM'N, http://www.sec.gov/about/whatwedo.shtml (last visited Mar. 20. 2011).
(157.) See A JOINT REPORT OF THE SEC AND THE CFTC ON HARMONIZATION OF REGULATION, U.S. SECURITIES & EXCHANGE COMM'N (Oct. 16, 2009), http://www.sec.gov/news/press/2009/ cftcjointreport101609.pdf.
(160.) See Mission Responsibilities, supra note 155.
(161.) WILLIAMS, supra note 84, at 4. At the time of the passage of the Food and Drug Administration Amendments Act (FDAAA) in 2007, PDUFA IV user fees made up 47% of the FDA's human drug program budget. Id.
(162.) Herberholz, supra note 6, at 124.
Deirdre A. Clarke, Juris Doctor Candidate 2012, Loyola University New Orleans College of Law. I gratefully acknowledge the insight and guidance of Professor John F. Blevins, as well as the support of my parents, Donald and Amanda Clarke. Sincere thanks to Verna Moses for pushing me to submit the casenote that would ultimately lead me here. Also, thank you to my comment editor, Linda Hewlett, and fellow journal members for their input.
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|Author:||Clarke, Deirdre A.|
|Publication:||Loyola Journal of Public Interest Law|
|Date:||Mar 22, 2011|
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