Studies Show FDA’s Approval Process Varies for Devices, Rx Drugs
The ways in which FDA approves prescription drugs and medical devices "vary widely," with some drugs gaining approval after a single large-scale clinical trial, according to research published Tuesday in the Journal of the American Medical Association, the Washington Post reports (Dennis, Washington Post, 1/21).
Assumption of Safety, Efficacy
For example, one study found that many heart devices are approved by FDA in part on the assumption that they are safe and effective because they are updated versions of previously approved devices.
Aaron Kesselheim, an assistant professor at Harvard Medical School and one of the study's co-authors, said that although the devices undergo rigorous review when they are first approved, subsequent changes are often approved through a "supplemental" review process that does not always require the updated devices to be tested in human clinical trials. He noted that such devices receive an average of 50 changes in the years following the devices' initial approvals.
Rx Drugs Approved After One Study
The analysis, conducted by Yale University School of Medicine researchers, found that 37% of 188 drugs approved between 2005 and 2012 were approved after one clinical trial instead of the two FDA usually requires (Loftus, Wall Street Journal, 1/21).
Further, 34% of the approved drugs had a clinical study period of more than six months. The study also found that 32% of the trials compared the new product with an existing one, instead of against a placebo (USA Today, 1/21). In addition, the study found that 45% of the approved drugs' trials examined only surrogate endpoints, such as lab tests, instead of clinical health outcomes (Wall Street Journal, 1/21).
Still, the study noted that almost 90% of the drugs were studied in randomized trials, and nearly 80% were double-blinded.
Limitations Not Understood
According to Joseph Ross, one of the Yale researchers, patients do not always understand what it means when certain drugs receive less-rigorous testing than others. Ross noted that a 2011 survey found that 39% of people believe that FDA approves only "very effective" drugs, while 25% believe that the agency only approves treatments without serious side effects, neither of which is true. "'New and approved' doesn't necessarily mean 'new and improved,'" Ross said (USA Today, 1/21).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.