Beyond the neighborhood drugstore: U.S. regulation of online prescription drug sales by foreign businesses.
Drugstore.com, cvs.com, and walgreens.com are just some of the more than 400 known e-commerce businesses that dispense prescription drugs online. (1) A study of websites maintained by pharmaceutical companies conducted in mid-1997 forecasted the huge growth in this area of e-commerce. (2) For the most part, consumers obtain their medications from these pharmaceutical websites by mailing in prescriptions to them or by having their physicians phone-in prescriptions to the service provider. (3) Cvs.com, for example, specifies on its website that it will only fill prescriptions written by a licensed physician, and that it verifies all prescriptions with the customer's doctor. (4)
Many of these legitimate online pharmacies received pharmaceutical industry approval for their adherence to United States Federal Food and Drug Administration regulations. (5) The National Association of Boards of Pharmacy (NABP), which assists state licensing boards in pharmaceutical industry regulation, established the Verified Internet Pharmacy Practice Sites (VIPPS) program, which assigns a seal of approval to websites that meet NABP standards. (6) To date, several websites have been commended for their compliance under NABP and have received the seal of approval, including drugstore.com. (7) Moreover, these companies not only legitimately provide prescription medications for consumers, but they are also very lucrative businesses, with projected sales reaching $15 billion by 2004. (8)
Lurking in the shadows of these legitimate online pharmacies, however, are less-than-scrupulous websites, many based outside of the United States (9), which fill drug orders for consumers without medical prescriptions, (10) administer pharmaceuticals that do not have FDA approval, (11) provide medications that fall below the recommended dosage and potency levels, (12) and deceive consumers with the promise of miracle cures. (13) Referred to as "rogue" online pharmacies, (14) these sites greatly outnumber the legitimate online pharmacies--400 to 6 by estimates made in 2000. (15) Some internationally based web sites only require consumers to complete an order form and select a drug and quantity, (16) while others require consumers to fill out a questionnaire about their health without a medical opinion prior to the sale of the prescription drugs. (17)
Categorically, online pharmacies fall into four types:
" online pharmacies that are partners with traditional brick and mortar pharmacies ... ;  online pharmacies that are themselves brick and mortar pharmacies ... ;  online pharmacies that operate solely on the Internet ... ; and  websites, usually based outside of the United States, where consumers can order prescription drugs without a prescription...." (18) Typically, ordering from an online pharmacy requires a consumer to submit a written prescription, or at the very least requires a telephone conversation between the online business and the prescribing physician. (19) Not so in the case of the rogue pharmacies, or websites posing as such, particularly those based abroad. A survey of more than 2,000 online pharmacy services conducted in the year 2000 revealed that eighteen percent were based internationally, (20) as is the case of viagra-global.com. For instance, a disclaimer on the site holds the consumer responsible for knowing the health risks from using Viagra and claims that the online business is not liable in any way. (21) Furthermore, under its shipping policies, viagraglobal.com states that consumers are responsible for compliance with all laws that may affect them, "[e]specially relating to the importation and the use of Viagra." (22) Nothing on the site indicates the country of origin, or the address of the business, although prices are quoted in both dollars and the English pound. (23)
Ordering medications on-line is appealing to many consumers because the Internet provides a cheap alternative to purchasing at regular brick-and-mortar establishments. For example, prescription drug prices in the United States are four times as expensive as in Mexico, and twice as much as in Canada or the European Union. (24) Meanwhile, prescription drug costs in the United States are rising at a rate of eighteen to twenty percent per year. (25) A 2001 Internet survey of more than 3,000 Web users (26) revealed that 86 percent used the Internet to get information about pharmaceutical drugs. (27) A similar survey conducted in 1999 more closely studied participants' drug purchases on the Internet, and found that 16 percent of all respondents claimed to buy drugs on the Internet, 8 percent of those specifying that they purchased prescription medications online. (28) Of those numbers, 18 percent were North Americans and ten percent from Europe. (29) The foundation has the support of organizations worldwide. (30)
This note seeks to examine the legal and regulatory implications of the purchase of prescription drugs from international online pharmacies such as viagra-global.com. An analysis of current regulatory schemes, proposed legislation, and worldwide efforts in this area will also be discussed.
Part I will discuss measures already taken by the FDA, the United States Congress, the domestic pharmaceutical industry, the United States Customs Agency, and state law enforcement agencies to address the issues of importation of pharmaceuticals (31) purchased from international online websites. This section will also review proposed legislation aimed at regulation and enforcement in this new sector and the implementation of guidelines to ensure better consumer knowledge. Part II will take a similar analytical approach, but will focus on how other foreign countries deal with the same regulation and enforcement issues, in particular the European Union.
This paper's ultimate conclusion is that a balance must be struck between protecting the public health and safety, and providing consumers with choices that only a global market can offer. Though the need to regulate the inflow of medicines (especially those purchased and sold without a prescription) from the rogue online pharmacies is apparent, benefits such as privacy, (32) convenience, (33) and cost savings (34) offered by responsible websites should be safeguarded. While the United States should continue in its efforts to regulate the new industry, it would be apt to take heed from its European counterparts. And moreover, as Jane E. Henney, M.D., former Commissioner of Food and Drugs for the Food and Drug Administration, under the Clinton Administration, stated in her testimony before the Senate Committee on Health, Education, Labor and Pensions on March 21, 2000, consistent principles, both nationally and internationally, need to be implemented in order to lead to more safe and predictable results when dealing with online pharmacies. (35)
II. THE UNITED STATES BATTLES INTERNATIONAL ONLINE PHARMACIES
A. Regulations Now In Place
What was touted as "the first-ever bust of online pharmaceutical peddlers" by United States Customs occurred in March of 2000 in Thailand and resulted in 22 arrests. (36) In 1999, U.S. Customs seized 4.5 times as many illegal drugs from outside of the United States than it did the previous year. (37)
The FDA is the main federal regulatory agency that oversees the manufacture and importation of drugs into the United States. (38) Under the Federal Food, Drug, and Cosmetic (FD&C) Act, the FDA can take legal action against "the importation, sale, or distribution of an adulterated or misbranded drug; the importation, sale, or distribution of an unapproved new drug; illegal promotion of a drug; the sale or dispensing of a prescription drug without a valid prescription; and counterfeit drugs." (39) The import of drugs that have never been FDA-approved and unapproved foreign-made versions of FDA-approved drugs are also prohibited. (40) When the Internet is used as a tool for selling illegal drugs (that is, prescription drugs not approved by the FDA), the FDA, together with the Department of Justice, treat the development of charges and evidence, and the prosecution, just as they would if the drugs were illegally sold in a store or in a magazine. (41)
In July 1999, the FDA adopted an Internet Drug Sales Action Plan to address the issue of illegal sales of prescription drugs over the Internet. (42) The FDA estimates that approximately 2 million packages containing products, including prescription drugs, that are illegal under the FD&C enter the United States yearly. (43) Goals of the plan are public outreach efforts, outreach and partnering with health professionals, and coordinating efforts with other state and federal agencies. (44) The public outreach program includes providing information about purchasing drugs online in the FDA Consumer magazine and on the FDA website, (45) and providing a medium for consumer complaints or information on rogue sites. (46) In 2000, the Agency launched a new media campaign about safe ways to purchase pharmaceutical products over the Internet. (47) Under its cooperative efforts with other agencies, the FDA has created partnership agreements with the National Association of Boards of Pharmacies and the Federation of State Medical Boards. (48) The FDA also has worked in conjunction with the National Association of Attorneys General. (49)
The FDA's efforts to combat importation of products from foreign pharmaceutical websites are strongest where it is cooperating with other federal agencies and those in the international arena. (50) The Agency has worked domestically with the Department of Justice (DOJ), including the Drug Enforcement Administration (DEA) and the Federal Bureau of Investigation (FBI), the U.S. Customs Service (Customs), and the Postal Inspection Service. (51)
In June 1999, the FDA established a case evaluation program with the Office of Enforcement and the FDA's Office of Criminal Investigations (OCI), along with the Office of Regulatory Affairs (ORA), the Center for Drug Evaluation and Research (CDER), the Office of the Chief Counsel (OCC), and the Office of Policy. (52) The FDA regularly monitors the Internet for suspect websites or receives information on such sites from state, federal, or foreign law enforcement agencies, or from consumers, Congress, and the press. (53) This information is then evaluated by a case evaluation program team, which decides whether to pursue civil or criminal investigations. (54) Cases that involve "unapproved new drugs, health fraud, prescription drugs sold without a valid prescription and products with the potential for causing serious or life-threatening reactions" are given priority, and then are followed up, if necessary, by the FDA's civil and criminal enforcement units. (55)
During 2001, OCI had at least forty sites under active review for possible infractions of the FD&C. (56) Nearly half of the cases open for investigation involved the dispensing over the Internet of medications without a prescription. (57) In recent years, OCI has made 88 arrests based on Internet violations of the FD&C, 70 of which stemmed from drug sales. (58) Of the drug sales, eleven involved Internet pharmacy cases. (59)
The FDA's cooperation with the DOJ also has netted some great results. Thus far, 15 products have been seized, 5 preliminary injunctions have been imposed, 11 products have been recalled and 18 dangerous products have been voluntary destroyed. (60) Moreover, 36 shippers from foreign countries "have been placed on Detention Without Physical Examination ... for targeting sales of unapproved new drug products to the U.S." (61)
The FDA's Office of Criminal Investigations, along with overseas Customs offices, have netted a number of arrests in connection with the sale of illegal pharmaceuticals from abroad, and have seized over 1.5 million pills. (62) Moreover, OCI has established liaisons with the governments of Canada, the United Kingdom, Spain, Germany, Belgium, the Netherlands, Ireland, Brazil, and Singapore, to name a few. (63) Cooperation between OCI and authorities in a Pacific Rim country led to the investigation of a website operator who alleged that legitimate doctors reviewed the online health questionnaires provided to customers before drug sales were approved; this claim was found to be false and charges are pending. (64)
In September 2000, federal agents helped bust online pharmacies in Florida which were selling laetrile, an unapproved cancer drug which the company more than likely imported from Mexico. (65) The FDA sought a permanent injunction against the pharmacies, and a federal judge shut the companies down. (66) A less pragmatic approach has been taken by the FDA in the way of sending warning letters to websites that illegally sell drugs. (67) As of September 2001, the FDA had sent out 121 "cyber letters" to online sites selling prescription drugs in violation of the FD&C; (68) at least 13 similar letters have been sent to foreign-based Internet sites. (69) The letters, sent over the Internet, warn the websites of possible illegal activity on their part and provide information about United States laws governing prescription drug sales. (70) The letters also warn that Customs officials may confiscate any future shipments from the company. (71) Hard copies of each letter are sent to the website operator, Customs , and to regulatory officials in the country of origin of the website. (72) As an aid to consumers, the FDA has dedicated part of its website to helping consumers safely fill prescriptions over the Internet. (73)
The Federal Trade Commission (FTC) also got involved in the crackdown on online pharmacies, charging several companies in July of 2000 with "falsely claiming to run `full service clinics'," when in reality only one doctor was part of the
claimed network of physicians. (74) Under an agreement with the FTC, the online companies agreed to stop certain trade practices. (75)
In the summer of 2000, Customs expanded its CyberSmuggling Center, adding a Cyber Crimes Unit to actively search the Internet for rogue pharmaceutical websites. (76) In 2001, Customs teamed up with the FDA to conduct a five-week study at the Carson Mail Facility in Carson City, California. (77) Based on statistics gathered the first week of the operation, it was estimated that 16,500 international packages coming through the facility could have been set aside for FDA review for possible violations during the five-week pilot. (78) Lack of manpower at the FDA meant that only 1,908 of those packages were actually reviewed. (79) Of those inspected, 721 parcels containing 197 different types of drugs were found to contain medical products that were unapproved for use in the United States. (80) The packages came from 19 different countries. (81) During a four-hour investigation on April 11, 2001, at seven border crossings from Mexico to the United States, FDA and Customs stopped 586 people for bringing in more than 1,000 drugs. (82)
The industry itself is setting standards for all online pharmacies. As mentioned earlier, (83) the National Association of Boards of Pharmacy (NABP) has established a "`Good Housekeeping' type seal of approval" (84) for websites that meet criteria for "patient rights to privacy, authentication and security of prescription orders, adherence to a recognized quality assurance policy, and provision of meaningful consultation between patients and pharmacists." (85) During its 97th annual meeting on May 7, 2001, NABP adopted the recommendations of its Task Force on Expanded Use of the Internet in Pharmacy Practice and Regulation. (86) The recommendations included advising state boards of pharmacy to address the use of the Internet for prescription filling and information in their model acts; continuing the relationship between the FDA, Customs and the state boards; and expanding the VIPPS certification program to international websites. (87)
Local action also has been taken by attorneys general in several states, including Missouri, Michigan, Kansas and Illinois. (88) Most state laws require a patient receiving a certain medication for the first time to be physically examined by a licensed health care practitioner, and further require the patient to have the prescription filled by a registered pharmacist working in a licensed pharmacy. (89) Usually the state-originated accusations against the websites stem from a failure to register with state authorities, the filling of prescriptions from doctors not licensed to practice in the particular state, or violations of consumer fraud protection legislation. (90)
Kansas has been called a leader in the movement to prosecute rogue websites, filing six lawsuits in recent times that resulted in the payment of fines and obstruction of such sales in Kansas. (91) At least twelve other states have also filed suits against physicians for illegally prescribing medication over the Internet, (92) and more than 20 states pursued the Internet pharmacies themselves. (93)
Cooperation between OCI and local police over an 18 month period netted 98 drug seizures at the Dulles International Airport Mail Facility in 2001. (94) The shipments came from 13 different countries and 87 of the 98 seizures involved purchases made on the Internet. (95) Those efforts led to the prosecution of nine people. (96)
B. Proposals for Change and Improvement
The Internet Prescription Drug Consumer Protection Act ("the Act") of 2000, presented to the Congressional Committee on Health, Education, Labor, and Pensions in October 2000, addresses some of the enforcement issues faced by state attorney general offices in their fight against domestic rogue pharmacy websites. (97) Traditionally, states have regulated the prescribing and dispensing of medications through laws and licensing requirements. (98) But low start-up costs, relative anonymity and the transient nature of many online sites make locating and prosecuting rogue websites cumbersome, if not impossible. (99) Furthermore, varying drug approval methods and marketing in foreign countries make enforcement and regulation more difficult. (100) Most pressing of the issues facing attorneys general is the fact that several states file separate suits against the same rogue pharmacy websites and doctors, creating redundancy and wasting limited enforcement and prosecution resources. (101) The proposed legislation, with a reported backing of $10 million in funds, (102) would create national injunctive relief, (103) as well as requirements such as disclosure of the website's address and state licensing information. (104) Moreover, the legislation would enable state attorneys general to file class action suits in district courts against Internet pharmacies. (105)
Jane E. Henney, M.D., formerly with the FDA, has said that the $10 million funding "would allow [the] FDA to re-direct its ... resources back to other enforcement priorities and establish a significant, permanent presence on Internet drug sales enforcement." (106) In its earliest form, the legislation sought to bring regulation and enforcement under the control of the FDA, but critics were skeptical of the federal government's intervention in what has traditionally been a state enforcement role. (107) Nonetheless, there is much support for the legislation, including from established and legitimate online pharmacies like drugstore.com. (108)
The Act would also require online pharmacies to provide information on their websites about "their ownership, state licensure, name of the pharmacist in charge, and a phone number where consumers can contact the pharmacist" much like the information now accessible to consumers who purchase at brick-and-mortar establishments. (109)
Criticized early on for its lack of forcefully addressing the international arena on the issue of online pharmacy purchases, (110) the Act in its final form would "freeze domestic assets of illegal foreign web sites [sic]." (111) The legislation would give "the Department of Justice the ability to stop illegal foreign operators from collecting payments from U.S. customers," an effort aimed at dissuading international rogue online pharmacies from wanting to sell to United States consumers. (112) Currently, the FDA has jurisdiction over residents in a foreign country who violate the FD&C Act, but practically speaking, the Agency rarely enforces the Act against foreign sellers. (113) Rather, the FDA usually requests foreign governments to take action against the Internet seller, or has Customs stop the imported drug at a U.S. port-of-entry. (114) In his testimony before the Commerce/Oversight and Investigations Congressional Subcommittee, former Department of Justice Deputy Associate Attorney General Ethan Posner suggested an amendment to 18 U.S.C. [section] 1345 (115) which would enable the Department of Justice to go after domestic, as well as foreign, pharmaceutical websites by enjoining financial transactions traceable to illegal sales of prescription drugs online. (116) The proposed legislation would give U.S. officials more bite by requiring "the Secretary of Health and Human Services to make recommendations to Congress for coordinating activities of the federal government with those of other countries to curb illegal Internet sales from abroad" and to better educate the public about buying prescription drugs online. (117)
In its efforts to continue industry self-monitoring, the NABP formed a coalition in 1999 whose goals include forming "a task force on technology to develop legislative and enforcement initiatives" and "to develop an aggressive consumer education plan...." (118) One task force, dubbed the Task Force on Centralized Prescription Filling, convened in the summer and spring of 2000 and in September released its recommendations to amend the NABP's model act to include formation of a task force and to create model regulations specifically addressing the dispensing of prescription drugs on the Internet. (119)
The 2001 Agriculture Appropriations conference report, proposes an amendment that would open up importation and reimportation of FDA-approved drugs. (120) The goal- to allow consumers to purchase drugs at reduced prices from legitimate online sources. (121) Currently, the FDA only allows "importation of small quantities of unapproved drugs for personal use." (122) The FDA requires that people importing drugs for personal use file what is called an entry notice with the United States Customs Service. (123) Without the entry notice, importation of drugs that have never received FDA approval, or unapproved foreign-made versions of FDA-approved drugs, is illegal. (124)
Calvin Anthony, P.D., Executive Vice President of the National Community Pharmacists Association, has said that "while the pharmaceutical manufacturers and drug wholesalers have said drug importation would compromise patient safety, access to imported drugs actually could improve safety, since consumers have been turning to dubious sources to obtain drugs more cheaply." (125) The American Medical Association and Senator Hillary Clinton have both given their support to reimportation legislation. (126) Both the Senate and the House approved the conference report in October 2000. (127) Import regulations would take up to two years to develop. (128)
In his presentation before the House of Representatives on October 3, 2000, Representative Greg Ganske testified about the importance of signing the reimportation act into law. (129) Currently, if a United States consumer purchases a federally approved drug overseas (whether on a vacation trip or through an online transaction) and the drug is brought into the United States for personal use, "he is likely sent a threatening letter from the Food and Drug Administration saying that he is breaking a law...." (130) Representative Ganske predicts that reimportation, which would reflect the lower prices of foreign countries, (131) would generate more competition within United States borders, and thus bring down domestic prices. (132) For example, a thirty-day supply of Prilosec costs approximately $139.00 in the United States, while the same amount, manufactured in the same plant under the same FDA regulations but exported to another country, sold for about $55.00 in Canada; $17.50 in Mexico; and $39.00 in Europe. (133) Representative Gil Gutkneckt, also speaking before the House in support of reimportation, stated that competition in the United States would be fostered when world market prices become available to Americans. (134)
Just before the legislation was to be considered for inclusion in the Fiscal Year 2000 Agricultural Spending Bill in the fall of 2001, the legislation was watered down because of pressures from the pharmaceutical industry, according to Representative Bernard Sanders, a vocal advocate for reimportation legislation. (135) The loopholes include no requirement that drug companies allow reimported medications to display FDA-approved labeling, and fail to prohibit domestic pharmaceutical companies from imposing contract terms on foreign wholesalers that could undermine the law's intent. (136)
In late January 2001, Representative Sanders and a team of other lawmakers, drafted language for a bill that would eliminate many of the loopholes. (137) They estimated that a reimportation law with fewer loopholes would lower prescription drug prices by up to 50 percent. (138) Representative Sanders introduced House Amendment 147 in July 2001, amending H.R. 2330 (139) to stop the FDA from prohibiting the reimportation of drugs originally made in the U.S. by "anyone other than the manufacturer." (140) That amendment failed, (141) but Representative Sanders' Prescription Reimportation, Improvement, Correction, and Enhancement Act, (142) introduced months earlier and which pertains to the reimportation by pharmacists and wholesalers, remains in the House Subcommittee on Health. (143)
Paul Abrams, former CEO of NeoRX Corporation, testifying on behalf of the Biotechnology Industry Organization (BIO) (144) before the Senate Committee on Health, Education, Labor and Pensions against reimportation laws, claimed that such legislation would only minimally affect prices and would "drive away investment in cutting edge, innovative research." (145) Reimportation, in many respects resulting in similar effects as would the federal government's imposition of price controls, would be detrimental to the biotechnology industry. (146) Abrams testified that proposed price controls in 1994 resulted in the "[drying] up [of] biotech venture capital" and posited that this proposal could have the same effect. (147) Furthermore, Abrams testified that consumer-level discounts could not be guaranteed under a reimportation scheme because wholesalers might not pass the savings on to consumers. (148)
Moreover, Abrams claimed that the FDA's ability to regulate the safety of imported drugs would be eroded. (149) Yet, former Secretary of Health and Human Services Donna Shalala reportedly stated that an additional $24 million would suffice to increase inspection services in the FDA to handle the new inflow of medications. (150) Representative Ganske referred to the $24 million as a "drop in the bucket compared to the billions of dollars that consumers in this country would save by having increased competition [as a result of reimportation]." (151)
Those who oppose reimportation could use foreignpharmacies.com as an example of why not to allow individual consumers to purchase drugs for themselves without prescriptions. The website uses the reimportation loophole, going as far as advertising "90 Day Supply-Legally." (152) Moreover, the site advertised up to 75 percent savings on some prescription drugs. (153)
III. INTERNATIONAL BATTLES AGAINST INTERNATIONAL ONLINE PHARMACIES
A. Regulations Now In Place
To better formulate a comparison between drug regulation in the United States and in foreign nations, a foundation should be formed to analyze the U.S. FDA's counterparts in some key countries. Between the years 1970 and 1992, the United States recalled only nine drugs because of dangerous side effects; in the United Kingdom, during the same period, twenty-three drugs were recalled; thirty in Germany; and thirty-one in France. (154)
In Japan, the Ministry of Health and Welfare regulates drug licensure, acting on recommendations from an advisory group composed of approximately 100 members from hospitals and medical facilities. (155) The country's National Health Insurance (NHI) system and the Ministry of Health have adopted price-setting mechanisms to control costs to consumers. (156) Yet, of the 3,100 new drugs approved in the past 20 years, only less than two percent would have received U.S. FDA approval. (157)
In the United Kingdom, the FDA's counterpart is the Medicines Control Agency (MCA), which is advised by the Committee on Safety of Medicines, a scientific panel. (158) Price-setting there is determined by a more technical and scientific approach, and unlike in Japan and perhaps the United States, it is not based on national health care or reimbursement policies of the National Health Service (NHS). (159)
In France, the regulatory agency is the Agence Francaise du Medicament. (160) Aside from the general requirements of safety and quality, the agency's drug registration and price policies are directly linked to reimbursement policy. (161) Prices are developed "according to criteria set forth by the Commision du Transparence, a body composed primarily of economists that consults with the Agence du Medicament on matters of scientific information and judgment." (162)
These countries, like the United States, also face problems arising from online pharmacies based outside their borders. In Australia, for example, the president of the Pharmaceutical Society views the number of drugs coming into the country through online purchases as a serious problem. (163) Overseas websites used by Australians to purchase prescription drugs, not surprisingly, include many based in the United States. (164) While Australia has a personal use exemption similar to the one in the United States, (165) the Customs Department does ban the importation of illegal narcotics and large quantities of prescription medications. (166) Legislation slated to take effect July 1, 2001 would allow doctors to have patients' prescriptions filled online. (167) One Internet based pharmacy that would most likely benefit from the new legislation is Pharmacy Direct. (168) The site requires a valid prescription from a doctor before purchase of prescription medications is approved. (169) A search for the product Viagra on the site yielded a listing of the product categorized by dosage and number of pills per package, and the following statement: "This Item requires a Doctor's Prescription and cannot be ordered via the internet unless Pharmacy Direct are [sic] holding your prescription repeats. Pharmacy Direct will not be able to process prescription orders for customers until the prescriptions are received." (170)
In February of 2000, the New Zealand Health Ministry began to look at options to prevent the importation of drugs without prescriptions. (171) One group in New Zealand has taken somewhat of a novel approach. The Amcal Group allows member brick-and-mortar pharmacies to display their own information, including the name of the chief pharmacist and the pharmacy's address, on its website and provides consumers with a link to the pharmacy's own website. (172) The Amcal website also has "Health-E Topics," health information from news articles and research found around the world. (173) The fact that Amcal is linked to brick-and-mortar pharmacies makes it a good example of what author Robin Marshall suggests consumers should look for when purchasing drugs online. (174)
The United Kingdom's Medicines Control Agency (MCA) found that three-quarters of overseas websites advertising or shipping pharmaceuticals to the UK were based in the United States. (175) The MCA is now working with the FDA to address the issue. (176)
Whereas the United States' efforts have mostly concerned online pharmacies within its borders, Europe's concentration has been more global. For example, officials in Italy are urging "that the issue be addressed by the European Community as a whole." (177)
Following the 51st World Health Organization Assembly in 1998, the WHO and members of drug regulatory agencies, industry representatives, experts, and consumer organizations developed Medical Products and the Internet: A Guide to Finding Reliable Information. (178) The guide, to be translated into several languages, is proffered as a model for adaptation by European Union Member States. (179) It provides pointers on finding reliable medical product information on the Internet, including warning signs which could indicate that the information on the website may not be accurate. (180) For example, advertisements that claim scientific breakthroughs, or which claim that only one source can provide the product for a limited time, or which state that there are no risks linked to the product, should signal that the website is less than reliable. (181) Moreover, the guide provides information on how to be cautious about making purchases, (182) and offers a top-ten list of how prescription drugs bought on the Internet can pose dangers to consumers, including the fact that instructions may not provide adequate information, that the quality of the product may not be assured or that the products are actually imitations of the real thing. (183) More importantly, the guide flags ways on how to tell a website is reliable. (184) For example, a legitimate website will contain information on the active ingredients of a drug, the proper use of the medication, and possible undesired effects. (185)
B. Proposals for Change and Improvement
The European Commission, at the conclusion of a November 1999 hearing entitled Certain Legal Aspects of Electronic Commerce, issued a draft directive establishing rules whereby websites would be subject to e-commerce laws in their home nations. (186) The directive calls for the coordination of national laws to create a legal framework for addressing electronic commerce issues. (187) Most notably, the directive addresses the jurisdictional problems of e-commerce. It sets what it refers to as the "place at which a service provider is established" as determinative of which countries' laws will apply for prosecution and regulation of the same. (188) For example, a website based in France would be subject to the e-commerce laws of France. The directive also allows persons to sue in their home nations on breach of contract claims. (189) Implicitly, the customer's purchase from a website and the service provider's acceptance of the order would create a binding contract, which if broken, could provide for damages to the aggrieved party under contract law. (190)
Working with the WHO's ad hoc Committee on Cross-Border Promotion, Advertising and Sale of Medical Products Through the Internet is the Internet Healthcare Coalition (Coalition). (191) The Coalition, a non-profit organization out of Washington, D.C. aims to provide quality health resources and information on the Internet. (192) It pledged in 1997 to promote ethical practices on the Internet; to educate consumers and medical/healthcare professionals; and to support initiatives to harmonize global laws concerning commercial abuse of the Internet, particularly in the area of health and medicine. (193) Since that pledge, the Coalition has become a leading organization in the effort to educate consumers and healthcare professionals about safe utilization of the Internet. (194) On October 17, 2000, the Coalition, along with Hi-Ethics (Health Internet Ethics) (195) and Health On the Net Foundation (HON), (196) established the "e-Health Ethics Initiative" (Initiative) with the goal of creating a universal ethical code of conduct for health and medical websites. (197) The Initiative would strive to create a glossary of terms, enabling easier analysis of privacy and security statements made by websites and therefore helping consumers make more informed decisions about their online purchases. (198) The Initiative hopes to set worldwide standards for use by all nations. (199)
The HON has its own code of conduct for pharmaceutical websites (hereinafter "Code"). (200) The code contains eight principles, mainly focusing on the conduct of websites that provide health information to consumers. (201) Under the "Justifiability" Principle, the code calls for websites to provide clear references to data in support of claims of a drug product's benefits or performance , as well as HTML links to that data, where available. (202) Moreover, the Code demands that websites clearly state whether the source of information it provides is from a non-medically qualified source. (203) Another important principle, dubbed "Transparency of Authorship," requires that websites list contact addresses and clearly post their e-mail addresses throughout the site. (204)
The plethora of information on the Internet, coupled with its advantages to consumers--privacy, convenience, and accessibility--makes it one of the largest and most popular mediums for commerce. These same qualities, however, can also entice less than scrupulous people and businesses to take advantage of the unsuspecting consumer. The dangers inherent in these activities are magnified when it comes to the sale and purchase of pharmaceutical drugs online. Statistics show that an increasing number of people, many of them in the United States, turn to the Internet for their purchases of, or at least information on, pharmaceuticals. (205) The interest in this sector is obvious when one looks at the number of pharmacies now on the Internet, including mainstream brick-and-mortar pharmacies such as CVS and Walgreens. (206) The actions and initiatives of governments worldwide also indicate the importance of this issue, as well as the nuances.
Government regulation of online purchasing or gaining information about pharmaceuticals cannot keep up with the ever-changing Internet. Websites, now so easily established and removed from the World Wide Web, with their added anonymity, create some real enforcement and regulation issues. Add to that mix the dangers of the markets created by these websites for pharmaceutical drugs, and the result is very troublesome. The problems faced not only concern internal issues such as jurisdiction and enforcement, but also reach outside of national borders to globalized markets. Parts I and II of this note analyzed the issues and steps being taken to address the problems both in the United States and abroad. The overriding theme, when looking at the future of regulation in this area, is the implementation of worldwide legal standards. Such a solution would both protect consumers, while preserving their rights to choose in a free market economy.
If a worldwide standard is the ultimate goal, then finding a model for such a standard is logically the next step. While enforcing American legal standards on international online pharmacy companies may be difficult, and perhaps ill-received, it can serve as a starting point. At least one source has stated that the FDA licensing of a drug is renowned the world over as "prima facie evidence of a drug's safety, efficacy, and quality...." (207) Moreover, many Latin American and Eastern European countries view the FDA as a de facto agency for local drug registration. (208) It would therefore follow that FDA regulatory and licensing practices could be the model used around the world for regulating the safety of prescription drugs sold online. Individual nations would still monitor drug licensures and establish manufacturing regulations within their own borders, but products sold online could be held to a higher, or at least different, standard--that of the United States. Some may posit that this position would make the United States appear too self-promoting, however a model is the suggested means of harmonizing legal standards, not the end-all law of the land.
A universal consensus on jurisdiction, such as the one proffered by the European Commission, is the best choice for the prosecution of online pharmacies for wrongdoings. (209) Although investigations, prosecutions and other legal processes would not be uniform the world-over, having these activities conducted under the auspices of a single nation (the central location of the website) would prove efficient. Furthermore, one governmental agency within each nation should handle such legalities. The FDA should act as the United States' central prosecution and enforcement agency for rogue, on-line pharmacies based abroad, despite critics' skepticism. Uniform regulation and enforcement is imperative when dealing with a globalized problem such as this. The FDA has the power to form international memoranda of understanding (MOUs) with foreign governments. (210) MOUs promote the harmonization of laws, particularly in the area of regulation and enforcement, between foreign countries and the United States. (211) Development of such agreements between the FDA and its counterparts around the world, aimed at policies for regulating pharmaceutical sales on the Internet, is an important step towards globalizing legal standards. Continued individual state regulation and prosecution would make such uniformity impossible, not to mention inefficient.
Although the reimportation issue may make the enforcement initiative more difficult, it certainly would provide consumers with several economic alternatives. Reimportation of drugs already approved by the FDA could effectively provide domestic consumers with a market choice and cost savings opportunities, while simultaneously safeguarding against illegal or counterfeit drugs. Special licensing by respectable umbrella groups like the National Association of Boards of Pharmacy (NABP) that provide seals of approval to websites would help monitor the reimportation of drugs. Such licensing also would help consumers stay alert while not inhibiting their choices. (212) Approval seals would only be provided to websites (1) that sell FDA-approved drugs (including reimported ones); (2) that provide some form of website identification, namely the country and address of the website business; and (3) that require the submission of a valid prescription from a physician licensed in the United States.
Education initiatives would not only create a well-informed Internet consumer, but would help curtail illegal activities on the Web. Education initiatives like that of the Internet Healthcare Coalition, Hi-Ethics, and Health On the Net Foundation should therefore be encouraged. (213) Moreover, industry involvement would more than likely foster trust in the Internet medium, which would result in a growing number of online consumers who could realize greater cost savings.
One other suggestion to help regulate reimportation is allowing states to act as buyers' clubs for their citizens. (214) For example, AIDS buyers' clubs were allowed under the personal use importation exemption to purchase large quantities of unapproved AIDS drugs for distribution to their members. (215) This not only helps regulation, but also keeps consumers secure by providing them with safe products. The Commonwealth of Virginia had proposed to become a buyers' club in the early 1990s, including offering to conduct its own monitoring of the drugs being reimported, but the plan never came to fruition. (216) While the federal government should maintain regulation and enforcement, the public would also benefit from local initiatives by the states. Once reimportation legislation is enacted, state involvement should be encouraged.
In sum, governments should strive to provide consumers with safe, alternative and convenient choices for their medical and healthcare needs that extend beyond the borders of the United States. The adoption of measures to regulate and prosecute those who inhibit that choice or who endanger the public is essential.
(1.) Amy J. Oliver, Internet Pharmacies: Regulation of a Growing Industry, 28 J.L. MED. & ETHICS 98, 98 (2000).
(2.) Denise Silber, Pharmaceutical Industry Presence On the WWW, at http://www.ihealthcoalition.org/content/MWM_present6.html (last visited Jan. 29, 2002) (on file with the Rutgers Computer and Technology Law Journal). Statistics then showed that there were about 150 such websites in 1996 and about 200 by 1997. Id. The study also revealed that English was the dominant language used on the websites. Id.
(3.) See drugstore.com, Common Questions, at http://www.drugstore.com/ pharmacy/help (last visited Jan. 29, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(4.) CVS Online Pharmacy Store, Help: Answers to your questions, at http://www.cvs.com/CVSApp/cvs/gateway/help/helpRxPolicies.asp (last visited Jan. 29, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(5.) See Oliver, supra note 1, at 99.
(7.) National Association of Boards of Pharmacy, VIPP Information Site, at http://www.nabp.net (last visited Jan. 29, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(8.) Id. at 98. See also PlanetRX Shares Jump 128% On Nasdaq Debut, COMPUTERGRAM INT'L, Oct. 8, 1999 at http://www.computerwire.com/ computergram/subscribers.shtml (on file with the Rutgers Computer and Technology Journal); Drugstore.com Shares Rise 179% On Nasdaq Debut, COMPUTERGRAM INT'L, July 29, 1999, at http://www.computerwire.com/ computergram/subscribers.shtml (on file with the Rutgers Computer and Technology Journal).
(9.) See generally 146 CONG. REC. S10619-20 (daily ed. Oct. 17, 2000) (statement of Sen. Jeffords). According to one study, pharmaceutical sites out of Europe did not emerge until some time in 1997. Silber, supra note 2.
(10.) Oliver, supra note 1, at 99.
(11.) See generally Peter S. Reichertz & Melinda S. Friend, Hiding Behind Agency Discretion: The Food and Drug Administration's Personal Use Drug Importation Policy, 9 CORNELL J.L. & PUB. POL'Y 493, 496 (2000). See also Hearing on E-Drugs before the Senate Comm. on Health, Education, Labor and Pension, 106th Cong. (2000) [hereinafter Hearing on E-Drugs.] (statement of Jane E. Henney, M.D., Comm'r of Food and Drugs, FDA), available at http://www.fda.gov/ola/2000/pharmsales.html (last visited Jan. 29, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(12.) Reichertz & Friend, supra note 11, at 496.
(13.) See generally, World Health Organization, Medical Products and the Internet, ESSENTIAL DRUGS AND MEDICINES POLICY at http://www.who.int/ medicines/library/qsm/who-edm-qsm-99-4/medicines-on-internet-guide.html (last visitied Mar. 6, 2002) (on file with the Rutgers Computer and Technology Journal).
(14.) See generally 146 CONG. REC. S10619-20, supra note 9 (statement of Sen. Jeffords stating that rogue pharmacies pose a prominent danger to consumers); Politics & Policy Online Pharmacies: Officials Crack Down On `Rogue' Sites, AM. HEALTH LINE, Sept. 14, 2000 at http://nationaljournal.com/pubs/healthline (on file with the Rutgers Computer and Technology Journal).
(15.) Politics & Policy Online Pharmacies: Officials Crack Down On `Rogue' Sites, AM. HEALTH LINE, Sept. 14, 2000 at http://nationaljournal.com/ pubs/healthline (on file with the Rutgers Computer and Technology Journal).
(16.) Oliver, supra note 1, at 99
(17.) 146 CONG. REC. S10619-20 (daily ed. Oct. 17, 2000) (statement of Sen. Dodd). Such a practice is condemned by the American Medical Association. Id.
(18.) Oliver, supra note 1, at 98.
(19.) Oliver, supra note 1, at 98-99.
(20.) Politics & Policy Online Pharmacies: Experts Debate Regulation Options, AM. HEALTH LINE, June 16, 2000 at http://nationaljournal.com/ pubs/healthline (on file with the Rutgers Computer and Technology Journal).
(21.) Viagra-Global.com Order Form, at https://www2.usbusinessweb.net/ viagra-global/order/order.html (last visited Jan. 29, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(22.) Viagra-Global.com Shipping Policy, at https://www.viagra-global.com/ policies.html (last visited Jan. 29, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(23.) Id.; Viagra-Global.com Order Form, supra note 21.
(24.) 146 CONG. REC. H8732 (daily ed. Oct. 3, 2000) (statement of Rep. Ganske).
(26.) Slightly more than half of those who answered the survey, conducted between February and March of 2001 by the Health On the Net Foundation, were from the United States; twenty-six percent from Europe; with the remaining coming from, in descending order, Canada and South America. Health on the Net Foundation, Evolution of Internet use for health purposes- Feb/Mar 2001, at http://www.hon.ch/Survey/FebMar2001/survey.html (last visited Jan. 29, 2002) (on file with the Rutgers Computer and Technology Law Journal.) A similar survey conducted in 1999 had participants from such areas of the world as Oceania, Asia, Africa, the Middle East and Central America. Health on the Net Foundation, 5th HON Survey on the Evolution of Internet Use for Health Purposes, at http://www.hon.ch/Survey/ResultsSummary_oct_nov99.html (last visited Jan. 29, 2002) (on file with the Rutgers Computer and Technology Law Journal). Created in 1995, Health On the Net Foundation is a Geneva, Switzerland-based not-for-profit organization which compiles reliable online health and medical information for lay consumers and medical professionals. Health On the Net Foundation Homepage, at http://www.hon.ch/home.html (last visited Jan. 29, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(27.) Evolution of Internet use for health purposes, supra note 26.
(28.) 5th HON Survey on the Evolution of Internet Use for Health Purposes, supra note 26.
(29.) Id. Moreover, 58 percent of all respondents said they discussed drug information they obtained on the Internet with their primary care providers (75 percent of those being from North America). Id.
(30.) Evolution of Internet use for health purposes, supra note 26. Supporting organizations include the Health-e News Service of South Africa, IndiaOrth in India, Asociasion Internet Salud y Medicina of Colombia, Uropage of France, Poland's Allergen Research Center, Halifax Medical Center in Florida, and the American Geriatrics Society and The Foundation for Health in Aging in New York. Id.
(31.) This note will use the words "pharmaceutical," "drugs" and "medications" (or any variations thereof) interchangeably, to refer to medications for which United States licensed medical doctors must supply a prescription.
(32.) 146 CONG. REC. S10620 (daily ed. Oct. 17, 2000) (statement of Rep. Kennedy), at S 10620. See also Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(33.) 146 CONG. REC. S10620, supra note 32. Convenience to disabled or home-bound consumers in particular is a valuable advantage to online purchases of prescription drugs. See also Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(34.) See 146 CONG. REC. S10620, supra note 32.
(35.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(36.) Thailand, US In First Online Drugs Bust, AGENCE FRANCE-PRESSE, Mar. 21, 2000. Thailand is known for its production and sale of pirated versions of drugs including Viagra, steroids and tranquilizers. Id.; US Shuts Down Some Web-Based Pharmacies In Thailand, DOW JONES INT'L NEWS, Mar. 21, 2000.
(37.) Oliver, supra note 1, at 100.
(38.) See generally Reichertz & Friend, supra note 11, at 496.
(39.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(42.) Hearing Before the Senate Spec. Comm. on Aging, 107th Cong. (2001) (statement of John M. Taylor, Director, Office of Enforcement, Office of Regulatory Affairs, Food and Drug Administration), at http://www.fda.gov/ola/2001/healthfraud0910.html (last visited Jan. 29, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(43.) Hearing Before the Subcomm. on Consumer Affairs, Foreign Commerce and Tourism of the Senate Comm. on Commerce, Science, and Transportation, 107th Cong. (2001) [hereinafter Hearing on Commerce, Science, and Transportation] (statement of William K. Hubbard, Senior Associate Commissioner for Policy, Planning and Legislation, Food and Drug Administration), at http://www.fda.gov/ola/2001/importation0905.html (last visited Jan. 29, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(44.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(45.) U.S. Food and Drug Admin., Buying Medicines and Medical Products Online: Tips and Warnings for Consumers, at http://www.fda.gov/oc/buyonline/ default.htm (last visited Jan. 29, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(46.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(47.) Id. The campaign includes advertising on health-related websites, television public service announcements, and the development of a checklist for safer online drug purchasing. Id.
(49.) U.S. Food and Drug Admin., Buying Medicines and Medical Products Online: General FAQs, at http://www.fda.gov/oc/buyonline/faqs.html#faqs9 (last visited Feb. 12, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(50.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(56.) Hearing on Commerce, Science, and Transportation, supra note 43 (Statement by William K. Hubbard).
(59.) Id. A report in 2000 revealed that the FDA had 54 investigations into rogue websites as of that time period, 36 arrests, and seventeen convictions all stemming from the sale of products on the Internet. Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(60.) Hearing on Commerce, Science, and Transportation, supra note 43 (Statement by William K. Hubbard).
(62.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(65.) Marc Kaufman, FDA Is Moving To Halt Online Sales of Laetrile; Sites Promote Unapproved Cancer Therapy, WASH. POST, Sept. 7, 2000, at A2.
(66.) Id. For other actions the FDA has taken against online pharmacies illegally selling drugs, see Richertz & Friend, supra note 11, at 507 (the FDA charged at least one company with "shipping an unapproved version of Prozac...."); Politics & Policy Online Pharmacies: Officials Crack Down On `Rogue' Sites, supra note 14 (the FDA targeted fifty sites for their illegal actions).
(67.) Oliver, supra note 1, at 100.
(68.) Hearing on Commerce, Science, and Transportation, supra note 43 (Statement by William K. Hubbard).
(69.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(70.) Id. See also Kaufman, supra note 65.
(71.) Kaufman, supra note 65.
(72.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(73.) Reichertz & Friend, supra note 11, at 508.
(74.) Politics & Policy Online Pharmacies: FTC Cracks Down On Trade Practices, AM. HEALTH LINE, July 13, 2000 at http://nationaljournal.com/pubs/ healthline (last visited Mar. 6, 2002) (on file with the Rutgers Computer and Technology Journal).
(76.) State Ags Need Power to Pursue Online Pharmacies In Federal Court--Bliley, THE PINK SHEET Vol. 62, No. 022, Pg. 23 (FDA/F-D-C Reports), May 29,2000 [hereinafter THE PINK SHEET].
(77.) Hearing on Commerce, Science, and Transportation, supra note 43 (Statement by William K. Hubbard).
(80.) Id. Officials discovered six controlled substances among the packages, including lorazepam, codeine sulfate and diphenoxylate, and about ten percent of the drugs were antibiotics. Id.
(82.) Id. The drugs seized in the Mexico investigation included antibiotics, estrogen, allergy medications and drugs for diabetes, anxiety and depression. Id.
(83.) Oliver, supra note 3 and accompanying text.
(84.) Oliver, supra note 1, at 99.
(85.) Nat'l Ass'n of Bds. Of Pharmacy, VIPPS Information Site, at http://www.nabp.net (last visited Feb. 12, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(86.) Nat'l Ass'n of Bds. Of Pharmacy, NABP Committees and Task Forces Present Reports, at http://www.nabp.net/index.asp?target=/whatsnew/ pressreleases/webPR.asp&idValue=116 (last visited December 28, 2001) (on file with the Rutgers Computer and Technology Law Journal).
(87.) Task Force on Expanded Use of the Internet in Pharmacy Practice and Regulation, at http://www.nabp.net/ftpfiles/task_force_reports/ Task_Force on Expanded_Use of the Internet in Pharmacy_Practice_and_Reg ulation.doc (last visited Mar. 6, 2002, 2001) (on file with the Rutgers Computer and Technology Law Journal).
(88.) Oliver, supra note 1, at 100. See also Politics & Policy Online Pharmacies: Officials Crack Down On `Rogue' Sites, supra note 14.
(89.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(90.) Oliver, supra note 1, at 100. For more detailed information about prosecutions in Missouri, Illinois and Michigan, see id.
(91.) Politics & Policy Online Pharmacies: Officials Crack Down On `Rogue' Sites, supra note 14.
(93.) THE PINK SHEET, supra note 76.
(94.) Hearing on Commerce, Science, and Transportation, supra note 43 (Statement by William K. Hubbard).
(97.) 146 CONG. REC. S10619, supra note 14. The bill remains in the Senate subcommitttee and no further action had been taken on it as of January 2002. Bill Summary & Status for the 106th Congress, at http://thomas.loc.gov/cgibin/bdquery/D?d106:2:./ temp/~bdAPoP:@@@L&summ2=m&|/bss/d106query.ht ml|#summary (last visited Mar. 15, 2001) (on file with the Rutgers Computer and Technology Law Journal).
(98.) 146 CONG. REC. S10621 (daily ed. Oct. 17, 2000) (letter of Carla J. Stovall, Attorney General of Kansas).
(99.) Id. Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(100.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(101.) 146 CONG. REC. S10620, supra note 14. Support for the bill comes from various sources, including the American Pharmaceutical Association and drugstore.com. Id. For various letters from the industry in support of the proposed legislation, see 146 CONG. REC. S10621-22 (daily ed. Oct. 17, 2000).
(102.) Oliver, supra note 1, at 100.
(103.) 146 CONG. REC. S10620, supra note 14.
(104.) 146 CONG. REC. S10622 (daily ed. Oct. 17, 2000) (letter of Peter M. Neupert, CEO and President of Drugstore.com).
(105.) THE PINK SHEET, supra note 76.
(106.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(107.) Oliver, supra note 1, at 100-01.
(108.) 146 CONG. REC. S10621, supra note 98.
(109.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(110.) State Ags Need Power to Pursue Online Pharmacies In Federal Court--Bliley, supra note 76. See also, Reaction Mixed to Administrative Bill On Web Drug Sales, CONGRESS DAILY/A.M., May 4, 2000.
(111.) 146 CONG. REC. S10620, supra note 32.
(112.) Id. at S10621.
(113.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(115.) 18 U.S.C. [section] 1345 (1994). [section] 1345 gives attorneys general authority to commence civil actions for injunctive relief in Federal courts against persons violating certain banking laws and Federal health care laws. Id.
(116.) 146 CONG. REC. S10620, supra note 32.
(117.) Id. at S10621. For a summary of the Internet Prescription Drug Consumer Protection Act of 2000, see id. at S10621-S10623. (118.) Oliver, supra note 1, at 99.
(119.) Nat'l Ass'n of Bds. of Pharmacy, Task Force on Centralized Prescription Filling, at http://www.nabp.net/index.asp:?target=/whatsnew/pressreleases/ webPR.asp&idValue=85 (last visited Mar. 26, 2001) (on file with the Rutgers Computer and Technology Law Journal).
(120.) See Rx Imports: Pharmacy Buying Groups & Foreign Wholesalers Make Contact, THE GREEN SHEET (FDA/F-D-C Reports) Vol. 62, No. 043, Pg. 22, Oct. 30, 2000 [hereinafter THE GREEN SHEET]. See also Hearing on Commerce, Science, and Transportation, supra note 43 (Statement by William K. Hubbard).
(122.) Reichertz & Friend, supra note 11, at 493-94 (emphasis added).
(123.) Id. at 499.
(124.) Id. at 496.
(125.) THE GREEN SHEET, supra note 120.
(126.) Reichertz & Friend, supra note 11, at 504.
(127.) THE GREEN SHEET, supra note 120.
(129.) 146 CONG. REC. H8732, supra note 24.
(130.) Id. A 1980 law forbids the reimportation of drugs into the United States and authorizes the sending of warning letters to consumers who do reimport, informing them that they are breaking the law. Id.
(131.) 146 CONG. REC. H8732 (daily ed. Oct. 3, 2000) (statement of Rep. Gutknecht).
(132.) 146 CONG. REC. H8732, supra note 24.
(135.) Press Release, Bernard Sanders, Member of Congress, Sanders' Coalition Nears Final Drafting of Language to Fix Prescription Drug Reimportation Law Loopholes (Jan. 25, 2001), at http://www.house.gov/bernie/press/2001/01-25-2001.html (last visited Mar. 6, 2001) (on file with the Rutgers Computer and Technology Law Journal).
(139.) The Federal Food, Drug and Cosmetic Act.
(140.) H. Amend. 147, 107th Cong. (2001).
(142.) H.R. 698, 107th Cong. (2001).
(144.) BIO is a trade group that represents "more than 900 biotech companies, universities, research institutions, state biotechnology associations and affiliates in 49 states." Drug Safety and Pricing Hearing, Before the Senate Comm. On Health, Educ., Labor and Pensions, 106th Cong. 82 (2000) (statement of Paul Abrams, M.D., J.D., CEO Ne0RX Corp.)).
(145.) Id. at 85.
(146.) Id. at 85-86.
(148.) Id. at 86.
(149.) Id. at 86-87. See also, Reichertz & Friend, supra note 11, 503 (FDA concern over reimportation stems from the uncertainty of the handling of drug products during the period of their export to foreign countries).
(150.) 146 CONG. REC. H8733, supra note 24.
(151.) Id. For a comprehensive list of the most updated releases, statements, and letters on the reimportation issue, see the website maintained by Rep. Bernard Sanders. Congressman Bernie Sander's Homepage, Stop Paying Too Much for Prescription Drugs : Document Center- Releases, Statements, Opeds, Leters and More, at http://bernie.house.gov/legislation/pharmbill/press.asp (last visited March 3, 2001).
(152.) Foreign Pharmacies.com home page, at http://www.foreignpharmacies.com (last visited Jan. 26, 2001) (on file with the Rutgers Computer and Technology Law Journal).
(153.) Id. The site does not sell the prescription drugs itself, but rather is a link to foreign pharmacies which then sell the products to members of foreignpharmacies.com. Id.
(154.) BRYAN L. WALSER, Shared Technical Decisionmaking and the Disaggregation of Sovereignty: International Regulatory Policy, Expert Communities, and the Multinational Pharmaceutical Industry, 72 TUL. L. REV. 1597, 1639 (1998).
(155.) Id. at 1630.
(156.) Id. at 1631. For a comprehensive description of the formulas used to price different categories of drugs, see Id.
(157.) Id. at 1632.
(158.) Id. at 1634.
(159.) See id.
(160.) Id. at 1636.
(163.) Beth Quinlivan, Drug Net Hits Pharmacists, Bus. REV. WKLY., Sept. 22, 2000, at 66.
(164.) See id.
(165.) See Reichertz & Friend, supra note 11, at 493-94; see also supra text accompanying notes 120-24.
(166.) Quinlivan, supra note 163, at 66.
(168.) Pharmacy Direct calls itself "Australia's first mail order pharmacy." Pharmacy Direct web page, at http://www.pharmacydirect.com.au (last visited Jan. 24, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(169.) Pharmacy Direct Medicine By Mail, Price List Based On The VIAGRA Product Name, at http://www.pharmacydirect.com.au/PDsearchproduct.asp (last visited Mar. 6, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(171.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(172.) See Ashbury Amcal Pharmacy Webpage, at http://www.amcal.co.nz/ view_pharmacy.cfm?MemberlD=68 (last visited Jan. 24, 2002) (on file with the Rutgers Computer and Technology Law Journal). See also Robin Marshall, Just the Prescription; New Zealand Pharmacies On-Line, THE PRESS, Oct. 5, 2000, at 22.
(173.) Marshall, supra note 172.
(174.) Id. For a comprehensive list of other ways consumers can protect themselves when purchasing online, see id.
(175.) Minister Welcomes Online Standards, CHEMIST & DRUGGIST, July 22, 2000, at 5.
(177.) Hearing on E-Drugs, supra note 11 (statement by Jane E. Henney, M.D.).
(178.) World Health Organization, supra note 13. For a complete version of the guide, see World Health Organization, Medical Products and the Internet: A Guide to Finding Reliable Information, at http://www.who.int/medicines/library/qsm/who-edm-qsm-99-4/ medicines-on-internet-guide.html (last visited Mara. 6, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(179.) Medical Products and the Internet, supra note 13.
(181.) See id.
(182.) Id. The guide warns that by purchasing online "you may risk your health and waste your money." Id.
(186.) Jim Gordon, Europe Looks To Local Online Laws: E.U. Struggles to Define the Terms of Continental E-Commerce, CORP. LEGAL TIMES, Mar. 2000, at 10. The European Parliament and the Council of the European Union approved and adopted the directive on June 8, 2000. Council Directive 2000/31/EC, 2000 O.J. (L178) 1.
(187.) Council Directive 2000/31/EC, 2000 O.J. (L178) 2.
(188.) Id. at 4. The directive clarifies that a place of establishment is not the place where the website's technological support is located, but where the website actively pursues its economic activity. Id. See also Gordon, supra note 186.
(189.) Gordon, supra note 186.
(190.) See id.
(191.) The committee was originally formed in response to the sale of prescription drugs on the Internet across borders. Press Release, Internet Healthcare Coalition, Internet Healthcare Coalition Responds to World Health Organization Working Group Recommendations On Medical Internet Use : Pledges to work with WHO to educate internet users and promote ethical use (Sep. 22 1997), at http://www.ihealthcoalition.org/about/ihc_pr1.html (last visited Feb. 13, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(192.) Press Release, Internet Healthcare Coalition, Top E-Health Ethics Groups Announce Collaboration: Hi-Ethics, Health On the Net Foundation, and the e-Health Ethics Initiative Collaborate on Ethical Codes of Conduct (Oct. 17, 2000), at http://www.ihealthcoalition.org/about/ihc_prg.html (last visited Feb. 13, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(193.) Internet Healthcare Coalition Responds to World Health Organization Working Group Recommendations On Medical Internet Use, supra note 191.
(194.) See Top E-Health Ethics Groups Announce Collaboration, supra note 192.
(195.) Hi-Ethics is a coalition of United States-based consumer health Internet websites and information providers that establishes ethical standards and practices for its 20 members sites. Id.
(196.) See HON, supra notes 26-30, and accompanying text.
(197.) Top E-Health Ethics Groups Announce Collaboration, supra note 192.
(198.) See id.
(199.) See id.
(200.) HON Code of Conduct (HONcode) For Medical and Health Web Sites Home Page, at http://www.hon.ch/HONcode (last visited Feb. 13, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(201.) HON Code of Conduct (HONcode) For Medical and Health Web Sites Principles Webpage, at http://www.hon.ch/HONcode/Conduct.html (last visited Feb. 13, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(202.) See id.
(205.) See, HON, supra notes 26-30 and accompanying text.
(206.) See supra notes 1-2 and accompanying text.
(207.) Walser, supra note 154, at 1638. In 1994, the FDA announced a pact between itself and the Russian Ministry of Health that "`effectively makes the U.S. Food and Drug Administration the major drug regulatory body for Russia.'" Id. at 1650-51 (quoting Russia Lifts Barriers to U.S.-Made Drugs, WASH. POST, Feb. 17, 1994, at 4A).
(208.) Id. at 1652.
(209.) See, Quinlaven, supra notes 163-64 and accompanying text.
(210.) FDA Compliance Policy Guide [section] 100.900, CPG 7150.19, available at http://www.fda.gov/ora/compliance_ref/cpg/cpggenl/cpg100-900.html (last visited Feb. 13, 2002) (on file with the Rutgers Computer and Technology Law Journal).
(212.) See drugstore.com, supra note 3 and accompanying text. Drugstore.com, which has received a VIPP seal of approval from the NABP, recommended that such a program be a "model for the purpose of promulgating regulations to implement ... disclosure requirements.... "146 CONG. REC. S10622 (daily ed. Oct. 17, 2000) (statement of Peter M. Neupert, CEO and President, drugstore.com). See also 146 CONG. REC. H8733 (daily ed. Oct. 3, 2000) (statement of Rep. Ganske) (suggesting a bar-coding system for packages whereby information on the place and time of manufacture, the ingredients contained in the drugs and their shipment route would be available on the product themselves).
(213.) See supra notes 172-75 and accompanying text.
(214.) See Reichertz & Friend, supra note 11, at 502.
(216.) Id. at 504.
Ivette P. Gomez, J.D. Candidate, 2002, Rutgers School of Law-Newark. The author dedicates this work to her husband for his never-ending love, support, and dedication to the fulfillment of her dreams. Special thanks to her parents por su amor y apoyo; los quiero siempre.
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|Author:||Gomez, Ivette P.|
|Publication:||Rutgers Computer & Technology Law Journal|
|Date:||Jun 22, 2002|
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