Advertising letters down 50% from FY '01; FDA vows more actions in '03.But ad staff increases at CDER CDER Center for Drug Evaluation and Research (US FDA)
CDER Centre de Développement des Energies Renouvelables (French)
CDER Client Development and Evaluation Report , CBER CB·er
One that uses a CB radio.
The Center for Drugs and Center for Biologics Biologics include a wide range of medicinal products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. issued only 34 warning and untitled letters in fiscal year 2002 (ended Sept. 30), down about 50% from 2001.
The decline has been expected ever since March when FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. Chief Counsel Daniel Troy started requiring all warning and untitled letters to be reviewed by his office. The policy was instituted by the Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979
Health and Human Services, HHS in December 2001 to ensure consistency and to prevent warning letter inflation.
However, critics, notably Public Citizen Health Research Group and Democrats in Congress, have said Chief Counsel review has delayed FDA's ability to act quickly on misleading drug advertising and other enforcement issues.
Addressing a Drug Information Assn. conference in New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of Feb. 24, Tom Abrams, director of CDER's Division of Drug Marketing, Advertising and Communications (DDMAC DDMAC Division of Drug Marketing, Advertising and Communications ), said: "We sent out about 30 letters last year. I want to see more letters sent out, but even more than that, I want to see less violations."
According to according to
1. As stated or indicated by; on the authority of: according to historians.
2. In keeping with: according to instructions.
3. 2001 data, DDMAC's untitled letters alone totaled 66 in fiscal 2001.
CBER, which has always had a smaller presence on the advertising scene, issued just four untitled letters in 2002, said Glenn Byrd, director of the Center's Advertising and Promotional Labeling Branch (APLB APLB Association for Pet Loss and Bereavement ).
While the Center for Devices disbands its Promotion and Advertising Branch in the Office of Compliance, Byrd and Abrams said their respective divisions are getting new staff to oversee advertising, particularly direct-to-consumer (DTC DTC
See: Depository Transfer Check
See: Depository Trust Company
See Depository Trust Company (DTC). ) ads.
Abrams said DDMAC plans to increase staff as a result of extra money allocated by Congress. Instead of one DTC review group, for example, there will be two. Other organizational changes are also under way.
Looking back over 2002, Abrams said the most common violations cited by DDMAC were the minimization of risk information, overstatements of efficacy, broadening the approved indication approved indication,
n 1. reliable signs that a certain remedy should be used. Not synonymous with “authorized.”
2. FDA-approved condition for a drug or other treatment that allows labeling. or target population of a drug, and unsubstantiated comparative claims.
But Abrams said the new advertising "Code of Conduct" issued in July by the Pharmaceutical Research & Manufacturers of America (PhRMA) has had tangible changes in the nature and type of violations coming through his office.
"We've seen less giveaways and less 2253 violations," Abrams said, referring to Form 2253, which makers of new drugs submit for their initial ad campaigns.
"Obviously, we're looking at the content of a promotion, not the types of gifts given out." The Department of Justice will be looking at those, he said.
Going forward, Abrams defined the three main priorities of DDMAC to be: the monitoring of DTC advertising, issues related to the launch of new products, and regulatory violations.
"Our highest priority will be reserved for serious safety risks and violations," he said, adding that the division receives more than 200 complaints per year. Each one is reviewed, and officials try to acknowledge each one within 30 days of receipt, during which time it is decided if the complaint has merit.
"If a complaint is deemed to have merit, it is prioritized according to the seriousness of the violation," he said, "and our definition of seriousness may be different than a company's definition. If one complaint is a competitive issue and one is a safety issue, the safety issue will be addressed first."
Byrd said APLB staff increased from three people to six since Byrd's appointment in April 2002.
"If you're involved in drug approvals, I urge you to look at the letters posted on our site," Byrd said. "It's not enough to do just that, but it's a good starting point Noun 1. starting point - earliest limiting point
terminus a quo
commencement, get-go, offset, outset, showtime, starting time, beginning, start, kickoff, first - the time at which something is supposed to begin; "they got an early start"; "she knew from the ."
Byrd said a number of changes are underway at CBER, such as the establishment of the Office of Cell Therapy, Tissues and Gene Therapy. The group has also become increasingly involved with bioterrorism/counterterrorism products and activities.
He said APLB is still part of CBER's Office of Compliance and Biologics Quality, despite the pending reorganization of the two centers. FDA implemented on March 17 the third phase of the consolidation of CBER/CDER review functions by transferring more than 200 CBER staff to CDER.
"There is nothing definitive to date," Byrd said. "APLB is still part of the CBER Office of Compliance." He went on to say that "therapeutics therapeutics
Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. is only a small portion of APLB's work," noting the staff also is responsible for vaccines, blood, gene/cell therapy and biologic devices.
"Do not change where you send your materials until you are formally notified by FDA," he advised.
The Byrd and Abrams handouts are available for $15 plus retrieval, Doc. 12283W.