The Food and Drug Administration (FDA) is a frequent target of Congressional critics, sometimes for good reason. Earlier this year, Congress targeted the FDA after two highly critical reports were issued by the Government Accountability Office (GAO), suggesting that the FDA isn’t properly planning how to keep pace with medical science.
One report states that the FDA lacks goals, targets, and time frames for keeping up with scientific advances, while failing to track the money it spends on these efforts. The other report found fault with the FDA’s strategic plan, which is supposed to speed approval of drugs and devices, especially combination medical products, such as heart stents that also deliver blood thinners to prevent clots.
The first report takes issue with the fact that the FDA “issued strategic planning documents in 2011 and 2013 to guide its regulatory science efforts and identify priority areas for conducting work, but these documents do not specify the targets and time frames necessary for the agency to measure progress overall or within each of the eight priority areas related to medical products.” The report goes on to state, “while FDA cited examples of its achievements in regulatory science in a 2015 report, FDA cannot assess how those achievements constitute progress towards its goals. In addition, FDA lacks information about how funding targeted at regulatory science is distributed across the priority areas.”
The first report recommended that the Secretary of Health and Human Services should direct the FDA Commissioner: to develop and document measurable goals for its regulatory science efforts so it can consistently assess and report on the agency’s progress in regulatory science efforts; and to systematically track funding of regulatory science projects across each of its priority areas.
The second report found that the FDA’s strategic plan mentioned above “does not incorporate leading practices for strategic planning or document a comprehensive strategy for the centers.” The report notes that “the absence of a comprehensive long-term plan for medical product oversight may hinder FDA’s efforts to address emerging issues that require center collaboration, such as access to quality data.”
The second report recommended that in order to ensure that the FDA can effectively coordinate and integrate its medical product centers’ programs and emerging issues, the Secretary of HHS should direct the FDA Commissioner to engage in a strategic planning process, to identify challenges that cut across the medical product centers and document how it will achieve measurable goals and objectives in these areas.”
According to Senator Lamar Alexander, “these reports demonstrate the need for Congress to pass smart laws and then conduct rigorous oversight to ensure that an agency tasked with safeguarding the health of Americans isn’t falling behind.”
Other FDA Concerns
On top of bad press from the release of those GAO reports, the FDA also dealt with negative press relating to the number of generic drug applications rejected in the month ending April 16, 2016. In a data release of approvals and complete response letters (CRLs) for ANDAs, the FDA denied approval for an all-time high (dating back to FY 2013) of 190 ANDAs and approved 53 of the applications (16 applications were tentatively approved).
Those 190 denials served as a nearly 30% increase over the next highest month ever, which was the month ending March 16, 2016, during which the FDA rejected 147 ANDAs. Putting the 190 CRL figure in perspective, one finds that the FDA in FY 2016 has already rejected a total of 879 ANDAs, more than 21% of which occurred in late March and April, compared to a total of 1180 CRLs in FY 2015, 1254 in FY 2014, and 1251 in FY 2013.
Interestingly, the FDA has already approved 397 ANDAs in FY 2016, which puts the agency on pace to nearly double the total number of ANDAs approved in the previous fiscal years. However, the FDA has fallen back in line with its approval pace in recent months after an all-time high of 79 ANDA approvals in December 2015.
According to Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER), the FDA is making a significant dent in the growing ANDA backlog, after hiring nearly 1,000 new employees under the Generic Drug User Fee Amendments (GDUFA). According to Woodcock, FDA is hoping to have the backlog current before the next reauthorization of GDUFA in 2017.