FDA oversight less stringent for fast-tracked drugs and device modifications, studies find

Numerous fast-tracked drugs and updated medical devices lack sufficient follow-up data to ensure their safety and efficacy, according to two separate studies published Aug. 15 in JAMA.

Here are four things to know.

  1. The first study assessed the Food and Drug Administration's accelerated approval process, which grants fast-track approval for life-saving drugs that fill an unmet medical need. The agency approves the drugs based on fairly weak data and evidence, but requires drugmakers to conduct follow-up studies within three years to confirm the drug's efficacy.

  1. Researchers examined data for 22 drugs granted accelerated approval between 2009 and 2013. While FDA required 38 additional studies be performed on these drugs post-approval, only half of the studies have been completed as of 2016.

    "Our concern is that a lot of newer drugs approved through this pathway are not then being subjected to rigorous confirmatory trials in a timely fashion," said senior researcher Aaron Kesselheim, MD, an associate professor at Boston-based Harvard Medical School, according to the Arizona Daily Star.

  1. In the second study, researchers from UC San Francisco examined the FDA's process for regulating modifications and updates to high-risk medical devices like pacemakers and stents. They examined 83 studies supporting 78 applications for post-market device modifications approved by the FDA between 2006 and 2015.

  1. Researchers found the agency accepts much weaker evidence to support the approval of post-market device changes, compared to the data required for initial approval. Only 45 percent of the studies involved randomized clinical trials, 30 percent were blind trials and only 38 percent of primary clinical outcomes were compared with controls.

    "Studies without randomization are prone to various types of bias, making it difficult to ascertain whether these modified devices are safer or more effective," the researchers wrote in the study.

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