Half of Post-Market Trials for Products With Accelerated FDA Approval Not Complete, Report Says
Drug companies that are granted accelerated approval by FDA for some treatments complete only about half of post-market clinical trials promised as a condition of approval, according to a congressional report commissioned by Rep. Edward Markey (D-Mass.) and released Wednesday, the Los Angeles Times reports. Since 1992, FDA has granted pharmaceutical companies accelerated approval following an abbreviated series of clinical trials if a medication appears promising in the treatment of a life-threatening illness. The companies must agree to conduct more complete studies gauging safety, efficacy and side effects after the drug is sold.
Accelerated approval drugs are not required to include any additional warnings (Alonso-Zaldivar, Los Angeles Times, 6/1). For the report, Markey staff members examined FDA and Securities and Exchange Commission data and found that drug companies have not completed 42 of 91 studies ordered on products that were approved from 1993 to October 2004.
Of the studies that have not been completed, 21 have not yet begun and three studies have been delayed. The report also found that 68% of drug companies did not disclose to SEC that they were required to conduct additional studies. According to the Wall Street Journal, "It is unclear if companies were required to divulge that information."
As a result of his findings, Markey plans to introduce a bill next week that would give FDA more authority over prescription drug labeling, such as requiring that labels indicate whether the drug was authorized for sale under accelerated approval. The bill would establish fines of up to $1 million a day for failing to conduct timely post-market studies. The measure also would give FDA the authority to order post-market studies on products even if they received regular approval (Corbett Dooren, Wall Street Journal, 6/1).
Markey said, "It is outrageous that drug companies and the FDA have been dragging their feet when it comes to conducting required post-marketing studies" (AP/Long Island Newsday, 6/1). "It was supposed to be a system of approve today and prove tomorrow. But it's become a system of approve today, but no further proof needed," Markey said (Henderson, Boston Globe, 6/1). He added that his forthcoming bill would "address the failures of the drug companies and the FDA to do their due diligence" (AP/Long Island Newsday, 6/1).
Thomas Fleming, chair of the biostatistics department at the University of Washington, said, "When the (maker) of a drug is in a pre-market setting, there is a sense of urgency to do a reliable assessment. When accelerated approval has been provided, there is a loss of urgency" (Los Angeles Times, 6/1).
FDA spokesperson Susan Cruzan said that the agency has not reviewed the report but added that "accelerated approvals allow the agency to give earlier access to promising therapies for serious and life-threatening conditions" (Boston Globe, 6/1).
Caroline Lowe, Pharmaceutical Research and Manufacturers of America vice president of scientific and regulatory affairs, said that the recall rate of accelerated approval drugs has remained constant at 3% since their inception, indicating that the process has not introduced unsafe products (Los Angeles Times, 6/1). Several representatives from various large drug manufacturers said that they take accelerated approval seriously and that they are continuing to conduct post-market clinical trials, the Globe reports (Boston Globe, 6/1).