Healthy Skepticism Library item: 8318

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Publication type: news

Kaiser Network.
Prescription Drug Makers Have Not Begun Many Pending Post-Market Studies on Newly Approved Drugs, FDA Says
Daily Health Policy Report 2007 Feb 2
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=42696

Full text:

Prescription drug companies as of Sept. 30, 2006, have not begun 71% of post-approval studies that were promised as a condition of FDA approval of a drug, according to an annual FDA report released on Thursday, Bloomberg/Long Island Newsday reports. Drug makers often agree to conduct post-market studies of safety, dosage and other factors of a drug to receive FDA approval. According to the agency, 899 of 1,259 pending post-approval studies have not been started (Bloomberg/Long Island Newsday, 2/2). FDA found that of the post-approval studies that had been initiated, 184 were on or ahead of schedule, 144 had been submitted for FDA review or terminated, and 31 were labeled as “delayed.” The FDA report did not indicate the number of drugs covered by the studies, as some drugs require multiple studies. In addition, the report did not specify over what time period the studies had been requested. Not all of the uninitiated studies were considered late by the agency, because drug companies and FDA can spend months discussing study design (Bloomberg/Los Angeles Times, 2/2). Post-approval studies usually are voluntary, so FDA cannot impose fines or penalties on drug companies who do not conduct the studies. Bill Vaughan, senior policy analyst with Consumers Union, asked, “How can the FDA claim it is committed to improving drug safety when it can’t even get drug makers to do the studies they promise? Should consumers really feel safe when two out of three studies aren’t being done, and the FDA doesn’t even have the authority to get them done?” FDA spokesperson Susan Cruzan said the agency is working to improve its ability to track and monitor post-approval studies and is looking to work with drug makers to complete the studies. Alan Goldhammer, deputy vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said that drug companies are committed to finishing post-approval studies but sometimes have difficulty finding study participants (Bloomberg/Long Island Newsday, 2/2).