The U.S. Food and Drug Administration (FDA) has faced persistent challenges in hiring and retaining top talent in the centers that review medical products. The public servants working at the agency strive to protect public health by ensuring the safety, efficacy and security of medical products and by ensuring the safety of the country’s food supply and cosmetics. Their mission is daunting when considering that it encompasses 20 cents of every consumer dollar spent in the United States.
FasterCures has been following this issue closely, and much of the problem can be traced to the fact that industry has a competitive advantage in vying for a very small pool of highly trained scientific, medical and technical experts. We have identified opportunities to address this disadvantage, and fortunately, many of these reforms were instituted when the 21stCentury Cures Act (P.L. 114-255) was signed into law on Dec. 13, 2016. We have updated our analysis to reflect these and other developments. (Also, FasterCures is tracking the implementation and impact of more than 100 provisions in the 21st Century Cures Act, including the workforce provisions.)
Despite these efforts at progress, reform is still needed.
As of Nov. 1, 2016, the Center for Drug Evaluation and Research (CDER) had more than 700 vacancies, a 13 percent reduction in force. The other medical product review centers are facing similar workforce shortfalls. In the spirit of March Madness, imagine that the FDA is a basketball team competing with only four players on the court.
The passage of 21st Century Cures provided hope that the agency could address its chronic understaffing using the newly granted hiring authorities. However, the Trump Administration’s temporary hiring freeze has added new uncertainty to the equation. The presidential memorandum directs the Office of Management and Budget (OMB) and the Office of Personnel Management (OPM) to develop “a long-term plan to reduce the size of the Federal Government’s workforce through attrition.” Once this plan is implemented, the hiring freeze will be lifted. The Department of Health and Human Services has issued more detailed guidance that suggests that many FDA positions may be exempt from the temporary freeze, but there is still much uncertainty.
More worrying are the implications of the “long-term plan” that OMB and OPM are developing. FDA is most certainly not an agency where it is in the public’s interest to further reduce the size of the workforce. There has already been a robust, bipartisan policy debate about the FDA workforce during the development of the 21st Century Cures Act. There is consensus that the agency needs to fill its vacancies, which requires new tools to recruit and retain the very best talent. The law provides those tools, and it passed with overwhelming majorities in Congress.
Stakeholders both inside and outside of government recognize the need for the agency to be fully staffed:
- The industry is putting its money where its mouth is by committing to additional resources for FDA staff as part of the new prescription drug user fee agreement (PDUFA VI) negotiated with the agency.
- Representatives Fred Upton and Dianna DeGette, the bipartisan champions of 21stCentury Cures, recently wrote to OMB requesting a clarification of FDA’s hiring status and highlighting the need for the agency to be empowered to address its chronic understaffing.
Representatives Upton and DeGette concluded their letter to OMB with, “FDA’s ability to hire and retain top scientific talent is crucial to advancing these shared, bipartisan goals.” This issue does not need to be re-assessed, and FasterCures hopes that OMB and OPM will be guided by that consensus. We and many other stakeholders will work diligently to ensure that FDA has the people it needs to accomplish its mission to protect the country’s health and safety.