FDA Drug Approval Processes Not Consistent

The clinical trials new drugs and devices must undergo for approval by the U.S. Food and Drug Administration hold the drugs to varying degrees of approval, according to a study published in the Journal of the American Medical Association.

Analyzing the FDA's public database of regulatory actions, Drugs@FDA, researchers examined the clinical approval trials for therapeutic agents.

Although the FDA recommends drug manufacturers submit two independent clinical trials to prove evidence of drug efficacy, researchers found 36.8 percent of product approvals were based on just one clinical trial. Approximately 39 percent underwent two clinical trials and 25 percent were approved on three or more.

Types of drugs were also held to different standards. Cancer drugs were the least likely to be randomized (47.3 percent) and double-blinded (27.3 percent) compared to the rest of the drugs. Trial duration also varied depending on whether the drug was pharmacologic or biologic, at 12 weeks and 24 weeks, respectively.

However, the variation is not necessarily all bad news, according to the researchers. "Such regulatory flexibility allows for a customized approach to approval, including the ability to rapidly approve potentially effective therapies for life-threatening diseases, such as certain cancers, or those diseases for which there is no existing effective treatment," they wrote.

Still, researchers suggest physicians be mindful of these variations and varying degrees of confidence of benefits when choosing the best treatments for patients. 

More Articles on FDA Approvals:

FDA New Drug Approvals Decline in 2013
Sofosbuvir Earns FDA Approval as Hepatitis C Treatment

For FDA, Expedited Drug Review Has Trade-Offs

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