Almost every document published by the Food and Drug Administration includes this disclaimer: “The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health …”
The second phrase, which acknowledges the FDA’s role as part of the Department of Health and Human Services, would need to be eliminated if a group of former FDA leaders has its way.
Seven of the past eight FDA commissioners would prefer to slide it out from under the HHS umbrella and make the FDA an independent agency. They believe this switch will help the FDA carry out its critical public health missions by cordoning it off from political pressure.
I have great respect for the men and women who have led the FDA. These highly skilled individuals have helped tame epidemics, bring about new medical discoveries, and dedicated their careers to improving the health and well-being of countless Americans. I am thankful for their service, yet I respectfully disagree with them on this point.
Plucking the FDA out of the orbit of HHS is an idea that has been bandied about before without gaining traction. As a former insider myself — I was counselor for public health and science at HHS during the Obama administration — I see at least three reasons why the FDA should stay where it is in the federal bureaucracy.
First and foremost, the FDA’s work does not exist in a silo. It is woven into the fabric of its sister agencies across HHS.
The FDA coordinates with the Centers for Medicare and Medicaid Services (which is part of HHS) to smooth market access for new and innovative medical devices. The two agencies have also worked together to improve drug safety surveillance. The FDA collaborates with the Centers for Disease Control and Prevention (another branch of HHS) when the nation is faced with a public health crisis, from infectious diseases like Zika or Ebola to outbreaks of contaminated food or addressing the opioid epidemic.
The FDA has also partnered with the National Institutes of Health (also under the HHS umbrella) to advance precision medicine and other medical breakthroughs. In fact, according to a 2017 report by the NIH, it has nearly 300 collaborations on the books with FDA, second only to partnerships forged between the NIH and CDC.
The NIH report rightly notes, “Given the complementary missions of CDC, FDA, and NIH, the three agencies often work together closely to build on each other’s strengths and achieve shared objectives.”
Making the FDA independent of HHS wouldn’t preclude this type of coordination entirely, but it would make it harder, less efficient, and perhaps less likely.
Second, there is no guarantee that the FDA as an independent agency would be immune from the political world. In fact, it could subject the agency to even more extreme political pressure. Consider an account by Paul Volker, the former chairman of the Federal Reserve — an independent government agency — during the Reagan administration. His new memoir reveals how he was summoned to the White House by President Reagan and his chief of staff, Jim Baker, and instructed not to raise interest rates before the election in 1984.
To be clear, this kind of political pressure shouldn’t happen. But we should also be clear that while FDA officials may not like answering to the powers that be at HHS, the alternative for an independent FDA might be answering to a higher political authority.
Third, as an independent entity, the FDA could be strategically disadvantaged amid disputes with other federal departments and agencies that have cabinet-level officials at their helm. Consider the FDA’s efforts to secure the nation’s food supply or improve nutrition. This work often involves coordination with the Department of Agriculture. Should there ever be a disagreement between the two, the commissioner of an independent FDA would have to go toe to toe with a cabinet-level secretary. That’s not a fair fight.
Part of the proposal to make the FDA independent of HHS anticipates this issue and may include a recommendation to designate it as a cabinet-level agency. Having independent agencies as part of the president’s cabinet is not unheard of — the current cabinet includes the Small Business Administration. Yet these independent entities typically enjoy the status of “cabinet rank,” which means that a president can remove them on a whim. I don’t think that’s a risk worth taking.
The men and women who lead the FDA, as well as the thousands of people who work there day in and day out, are dedicated public servants. They protect our health and safety in multiple ways that many Americans don’t even realize.
The best way to protect that work is not to hamstring the agency by breaking it away from HHS, but rather by appointing and hiring experts who recognize and protect the important role the FDA plays as part of the HHS family.
Bobby Clark, who served as counselor for public health and science at the Department of Health and Human Services during the Obama administration from 2015 to 2017, is a public policy consultant based in Washington, D.C.