Not all FDA-approved drugs undergo uniform, rigorous testing

The FDA has the power to fast-track the regulatory process of approval of certain drugs, usually those that are improvements on previous versions or can be studied through comparative studies with already-existing drugs.
Posted By Ananth Baliga  |  Jan. 21, 2014 at 5:04 PM
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Patients and consumers might assume that all drugs and medical devices approved by the Food and Drug Administration are uniformly tested, but new research shows that the amount of testing required to approve a drug can vary dramatically.

Two papers published Tuesday in the Journal of the American Medical Association, suggest that some FDA-approved drugs underwent very little testing as compared to the FDA's requirement for new drugs, which requires them to prove themselves in large, high quality clinical trials.

The first study, led by the Yale University School of Medicine, found that a third of drugs were approved after submitting a single clinical trial, and many others involved limited testing with a small group of patients. Forty percent of approvals involved comparative studies of new drugs with already-existing drugs.

According to Joseph Ross, senior author of the study and professor at Yale, the study showed that there was a "lack of uniformity in the level evidence" provided to the FDA pre-approval. The study was based on 200 or so approvals given by the agency between 2005 and 2012.

The FDA has responded by saying that while the agency does tweak clinical trials and other requirements depending on the drug, there is no leniency in the standard applied for approval.

“The agency applies the same statutory approval standards of safety and efficacy to all drugs, but uses regulatory flexibility in applying those standards,” spokeswoman Stephanie Yao said in a statement.

Authors of the Yale study did acknowledge the need for flexibility when it comes to drug testing and that having a one-size-fits-all approach was not required. They say their only intent was to inform patients and doctors about the differences in testing standards and to enable a doctor-patient discussion that looks into these matters.

Another study out of Harvard Medical School looked at approvals given to newer medical devices based on approvals received for older versions of it. According to Aaron Kesselheim, one of the authors of the study, such medical devices undergo rigorous testing when first being approved, but consequent upgrades or versions are deemed safe and effective based on earlier evidence.

These second-tier approvals, dubbed "supplemental review process," don't require manufacturers to perform clinical trials on humans.

"If you took a device approved 15 years ago and you put it side by side with the one from today, they might look nothing like each other," Kesselheim said.

[USAToday] [Washington Post] [JAMA]

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