A group of recent FDA commissioners from both sides of the aisle have found an issue they agree on: The agency should break up with the Department of Health and Human Services.
Seven recent commissioners dating back to the first Bush administration argue in an article published in Health Affairs that moving the Food and Drug Administration out of HHS would better allow it to operate using the latest science and evidence.
“FDA policies and actions are not driven by partisan politics: The scientific foundation for its decision making is guided by legislation that almost invariably has bipartisan support,” the former commissioners wrote. “We believe that our recommendations fit squarely within that bipartisan tradition of keeping the agency as up-to-date and effective as possible.”
The article was co-authored by Robert Califf, Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan, Andrew von Eschenbach and Frank Young. The former commissioners conducted an 18-month review of FDA’s role in the federal government, with backing from the Aspen Institute.
The piece comes as the government shutdown has sent nearly half of FDA employees home, putting a spotlight on the agency’s operations. Agency employees warn that an extended shutdown could be dangerous for health and safety. Monitoring labs down to a skeleton crew are not in a position to provide comprehensive surveillance, according to CNN.
The shutdown also prevented Commissioner Scott Gottlieb, M.D., from attending the J.P. Morgan Healthcare Conference this week; he still delivered his keynote through—disrupted—live feed, CNBC reported.
FDA needs to be able to nimbly react to an ever-changing scientific landscape, and at present even initiatives that enjoy wide support can stall and unfold slowly, the former commissioners wrote. For example, the Food Safety Modernization Act of 2011 enjoyed bipartisan backing and created a more proactive approach to food safety, but it took FDA five years to put implementation rules on paper, and full rollout is still far out.
Reconfiguring FDA into its own department would eliminate several layers of clearance within HHS and allow the agency’s work to progress more efficiently and quickly, they said. The current “administrative bottlenecks” can hinder beneficial programs.
The Health Affairs article offered interim steps that HHS could take to streamline FDA’s processes, as siphoning the agency would require an act of Congress and could take a substantial amount of time.
HHS should start with an internal evaluation for areas to ease the multilayered oversight of FDA, in collaboration with the commissioner, they wrote. HHS should also create a more direct line of communication between the commissioner and the department secretary, as that could speed up high-priority processes. Other suggestions include giving FDA full hiring authority and setting defined criteria for which initiatives require an Office of Management and Budget review.