GAO Questions FDA’s Post-Marketing Oversight for Drugs Approved via Expedited Programs
[Posted on: Thursday, 25 February, 2016] A survey conducted by the Government Accountability Office (GAO) found that FDA does not have robust processes to oversee the safety of drugs approved under expedited programs. There are 4 programs under which new drugs can be approved by FDA under reduce testing burden and shorter review times. These programs are priority review, breakthrough therapy designation, accelerated approval, and fast track program. All of these programs reduce the NDA/BLA review time by about 30% with further reduction in time to market by reducing the number of clinical and non-clinical studies required to support the market approval application. In the recent years, increasing number of sponsors take advantage of at least one of these expedited programs, with several applying for 2 or more programs for the same product. These programs are essential for encouraging innovation and have been critical for bringing therapies faster to patients. But due to the reduced testing requirements all aspects of safety of the product have likely not been addressed and are expected to be collected in a post-marketing study. According to the GAO report, “FDA lacks reliable, readily accessible data on tracked safety issues and post-market studies needed to meet certain post-market safety reporting responsibilities and conduct systematic oversight.” Questions have been raised if the expedited approval of drugs increases the risk to patients of unforeseen adverse effects. GAO found that FDA’s data on post-marketing safety information lacked completeness, timeliness, and accuracy of information. FDA concurred with the findings but argued that FDA-approved drugs that used an expedited program do not necessarily require different post-market safety monitoring than other drugs, noting that tracked safety issues and post-market studies are required for all drugs after they are approved by FDA. FDA also commented that the additional risks posed by applications that use an expedited program may be acceptable given the seriousness of conditions being treated. FDA acknowledged the GAO comment that under the current process it is not known whether drugs that were developed under these programs pose additional safety risks to patients once they are available on the market. FDA indicated to the GAO that it is working to improve its post-market oversight on all products by prioritizing identifying, evaluating, communicating about, and taking regulatory action to address safety issues by better information collection into FDA’s Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) used for post-market data. FDA also remarked that in the recent years (2014-2015), about 90% of post-marketing commitments and post-market requirements are being met by the sponsors. FDA promised to fill all the gaps in its processes related to post-market safety in the near future.
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