Healthy Skepticism Library item: 19545
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Henney J
The Drug Industry’s Performance In Finishing Postmarketing Research (Phase IV) Studies
Public Citizen 2000 Apr 13
http://www.citizen.org/hrg1520
Full text:
Jane Henney, M.D.
Commissioner, Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
Dear Dr. Henney,
The enclosed study, The Drug Industry’s Performance In Finishing Postmarketing Research (Phase IV) Studies, based on data obtained from the Food and Drug Administration through the Freedom of Information Act, paints a grim, dangerous picture. Pharmaceutical companies are systematically failing to fulfill their commitments to the FDA to do post-marketing (Phase IV) clinical studies of newly approved drugs, often required by the agency as a condition of approval. The results of Phase IV studies can provide important safety information to augment the FDA’s voluntary adverse drug reaction reporting system and could lead to more expeditious safety labeling changes or the withdrawal from the market of a new drug, if necessary.
From 1990 through 1994 a total of 88 new molecular entities (NMEs) were approved which had at least one Phase IV commitment. Only 13 percent (11 of the 88) were classified by the FDA as complete as of December 1999 (see table 1, page 5). This means that for at least five and as long as 10 years after drug approval, all of the studies for 87 percent of these drugs had not been completed. For the 107 NMEs with Phase IV commitments approved between January 1995 and the end of 1999, not one drug has been classified by the agency as having completed commitments as of December 23, 1999.
Previous research by the Health Research Group sheds further light on the Phase IV study issue. In late 1998, we surveyed FDA Medical Officers, who review New Drug Applications, regarding their attitudes towards the quality of the agency’s drug approval process. The Medical Officers’ comments on the issue of relying on postmarketing studies for approval of new drugs included the following:
“Good idea but no way to enforce Phase IV studies. If sponsors don’t do them correctly what recourse does FDA have? It’s tough to pull a drug.”
“My office director told me that he was going to overrule me because the sponsor (Wyeth-Ayerst) would just go over our heads to Capitol Hill. He felt it was best to approve the drug for an indication not studied and have the sponsors do a Phase IV post-marketing trial in support of the indication. I reminded him that this sponsor had failed to honor other Phase IV studies. He went ahead and approved the drug.”
The Medical Officers stated in our survey that 28 drugs had been approved in the previous three years only because Phase IV studies were required.
FDA advisory committee members may be more likely to recommend the approval of a new drug when there are questions of its safety and effectiveness if the manufacturer commits to Phase IV safety and efficacy studies. But, if advisory committee members were aware of the extraordinary failure of manufacturers to honor their Phase IV commitments, they might be less likely to recommend approval of a new drug based on the promise of a Phase IV commitment when lingering safety and effectiveness exist. We therefore ask that you send copies of the enclosed report to all FDA advisory committee members.
Under the current system, the FDA has the authority to revoke approval of some drugs for which Phase IV commitments have not been honored. This authority has never been invoked, nor is it clear that to do so would be in the best interests ofpatients. The FDA must ask for legislation to allow the agency to levy large civil monetary penalties against companies who fail to promptly finish phase IV study commitments.
We look for a prompt response to this serious problem.
Sincerely,
Larry Sasich, Pharm. D, M.P.H.
Staff Researcher
Peter Lurie, M.D., M.P.H.
Deputy Director
Sidney M. Wolfe, M.D.
Director
Health Research Group
