Despite an increase in the number of drugs approved through expedited pathways, the Food and Drug Administration struggles to track the safety of those drugs once they are on the market, a report made public Thursday by the Government Accountability Office found.
Expedited FDA pathways can allow for the approval of drugs based on clinical trials that are shorter or smaller than typically required. When any new drug goes on sale, the FDA monitors its safety and legally must report on some of its postmarket surveillance efforts.
“If FDA is shifting more of the safety risk to consumers by allowing fewer and shorter clinical trials on expedited drugs, adequate tracking of drug safety issues and review of postmarket studies are absolutely vital,” Rep. Rosa DeLauro, D-Conn., who requested the GAO investigation, said in a statement.
From October 2006 to the end of 2014, the FDA granted about two-thirds of fast-track requests, totaling 525 drug applications with a quicker approval pathway.
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Under an accelerated approval program, drug makers must conduct a “confirmatory trial” once the drug is on the market. If the results do not reaffirm the drug’s safety or efficacy, the FDA may withdraw its approval. In 2012, the cancer drug Iressa was pulled off the market after a confirmatory trial failed to demonstrate that it worked. In 2015, however, the drug came back on the market for a different patient population.
But the FDA does not adequately track studies like these, the GAO report found. The agency does not routinely monitor the progress of the studies and fails to review final reports on the studies in a timely manner. Data tracked by the FDA can be incomplete: staff at the FDA’s Center for Drug Research and Evaluation found the data entry for tracking safety issues to be “time-consuming” and “burdensome,” the report said.
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“FDA acknowledges that drugs approved through expedited pathways can pose additional risks for patients, yet this new GAO report clearly highlights that FDA is not doing its due diligence in tracking drug safety issues and post market studies that are critical in ensuring patient safety,” DeLauro said.
The House-passed 21st Century Cures Initiative (HR 6), could speed up the FDA’s approval process even further and rely more on effective postmarket surveillance. Critics of that bill, which is awaiting a Senate companion, said that this report highlights how this is already a problem.
“The drugs are getting to patients more quickly on the basis of preliminary data, but too many of these drugs do not actually benefit patients,” Diana Zuckerman, president of the National Center for Health Research, told CQ HealthBeat. “This very important GAO report shows that the get-drugs–to-market-more-quickly-trajectory at FDA is more dangerous than expected.”
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The FDA’s struggles with device surveillance were also made plain on Wednesday, when Sen. Patty Murray, D-Wash., released the results of an investigation into widespread bacterial infection outbreak caused by improperly cleaned duodenoscopes, devices which are used to diagnose and treat pancreatic issues.
“Patients should be able to trust that the devices they need for treatment are safe and effective,” Murray said in a statement on Wednesday. “Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented.”
Andrew Siddons can be reached at AndrewSiddons@cqrollcall.com.
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