- The Government Accountability Office last week released a report on the FDA's expedited drug approval processes and subsequent safety monitoring, finding significant flaws in the agency's oversight.
- Roughly one quarter of drugs approved for the U.S. market between October 2006 and December 2014 relied on at least one of the four expedited approval pathways, according to the report.
- However, the FDA lacked appropriate data systems to track safety issues related to these drugs after they went to market. Furthermore, due to the inaccessibility and unreliability of the FDA's postmarket data, the agency failed to issue quarterly reports on safety issues which are required by law, according to the GAO.
With accelerated approval pathways like the fast track and breakthrough therapy designations, the development process is shortened with the goal of getting important drugs to patients faster. As part of that process, the FDA is required to track safety issues following the initial approval of drugs, along with monitoring drug company's postmarket safety studies. Representative Rosa DeLauro (D-CT) asked the Government Accountability Office to assess how the FDA was performing in this capacity, and to detail how often the programs were used.
The watchdog agency found drug companies had submitted at least 770 requests for fast track designations since 2007, of which the FDA approved roughly two-thirds. The FDA was stricter in approving requests for breakthrough therapy tags, denying more than 50% of the 220 requests since 2012. All told, the GAO concluded about one-quarter of the drugs approved between 2006 and 2014 came to market via an accelerated pathway.
However, the FDA fell short in its required oversight and tracking of reported drug safety issues following these approvals, according to the GAO. This is of particular concern for drugs approved through an accelerated process as there is less development time to assess potential safety issues with an expanded patient population.
According to the report, "[the] FDA’s data on postmarket safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult."
In particular, the GAO flagged major issues with the accuracy and accessibility of the database the FDA uses to track postmarket safety issues. Additionally, the report noted issues with entering information into the database in the first place. Due to these problems, the FDA failed to issue statutorily required reports on drug safety issues. While the GAO found some efforts had been made to address these concerns, there was no comprehensive plan to remedy the deficiencies.
"The GAO report confirms my greatest fear, that FDA lacks fundamental resources and leadership in ensuring that drugs brought quickly to market are truly safe and effective," Rep. DeLauro said in a statement following the issuance of the report.