Healthy Skepticism Library item: 1149

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

FDA Reports More Than Half of Post-Approval Prescription Drug Studies Not Begun
California Healthline 2003 May 23

Full text:

The FDA yesterday said that more than half of post-marketing studies of drugs — which companies “routinely promise” as a condition of sales approval — have not begun, AP/Long Island Newsday reports. Treatment developers have not begun approximately 60% of 1,339 promised drug product research studies or 30% of 223 promised biological therapy studies, according to the FDA, which yesterday also released a Web site providing information on the status of follow-up studies. AP/Newsday reports that in some instances the FDA did not set a deadline for completion of the follow-up studies, which can be helpful for tracking drug side effects and proving medication efficacy. Among studies with deadlines, 2% of drug studies and 8% of biological studies are classified as delayed. For drugs approved through the FDA’s fast-track system, half of the post-marketing studies have been completed, 28% have not begun and 1.6% are officially delayed, AP/Newsday reports. “It shows there’s room for improvement” by drug companies and the FDA, Dr. John Jenkins, director of the FDA’s Office of New Drugs, said. Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, expressed disappointment in the findings and called for the FDA to seek congressional authority to impose fines on pharmaceutical companies that stall follow-up studies, AP/Newsday reports. Alan Goldhammer, vice president of the Pharmaceutical Research and Manufacturers of America, said the percentage of delayed studies “is very small” (AP/Long Island Newsday, 5/22).