The Food and Drug Administration should shift its emphasis from the preapproval period to postmarketing, when new drugs pose the greatest risk of safety problems, a sweeping report from the Institute of Medicine recommends.
Many safety-related issues in recent years–including the widely publicized struggles over labeling changes for antidepressants and the recall of Vioxx (rofecoxib)–have led to a lack of confidence in drug development and regulation, according to the 15 experts impaneled by the IOM.
“The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years,” the committee said in its report.
The FDA, in particular, has floundered, hampered by a lack of funding and mismanagement that has led to strife and miscues that may have resulted in delays in addressing safety issues, said the panel, made up of academicians, ethicists, and the head of the U.K. Medicines and Healthcare Products Regulatory Agency.
“FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organizational changes that have not been completed or sustained, and an apparent slowness in addressing lack of sponsor compliance,” according to the report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”
The committee recommended that FDA consider requiring new molecular entities to carry a special caution that the products' true risks and benefits are unknown. The FDA also should consider restricting or banning direct-to-consumer advertising of those products during that early marketing period, the committee said.
After 5 years, the FDA should formally review all the available data on those products and publicize the findings, the panel said. Also, results of phase II-IV clinical trials submitted to the FDA should be published on the Web site www.clinicaltrials.gov
The FDA should not be given unilateral authority, however, said the panel. “We understand that offering discretion does not mean offering dictatorial power,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.
Dr. Janet Woodcock, deputy commissioner for operations, said the Center for Drug Evaluation and Research has long recognized many of these issues and has been addressing them by doing things like establishing a drug safety board. The Pharmaceutical Research and Manufacturers of America also defended FDA's recent strides and the industry's safety record.