As Washington considers who should next lead the Food and Drug Administration (FDA), there will be a familiar temptation to focus on credentials. Should the Commissioner be a physician? A scientist? A lawyer? A policy expert?
As a former Secretary of the U.S. Department of Health and Human Services (HHS) and former FDA Commissioner, we know that more important to the role than any credential is understanding and being able to skillfully navigate policy, politics, and public service.
The FDA Commissioner does not need to be the nation’s doctor-in-chief. FDA already has physicians, scientists, statisticians, pharmacologists, toxicologists, epidemiologists, inspectors, lawyers, and other career experts whose job is to evaluate evidence.
The Commissioner must make sure FDA decisions are made through a process faithful to law, regulation, guidance, and science. The Commissioner must protect that process, hold the agency accountable to it, and defend the people who carry it out.
That means ensuring consistency, transparency, and predictability. When a company comes to FDA, receives guidance about how to develop a clinical program, spends years and millions of dollars following that guidance, and then returns only to be told that the agency now has a different “point of view,” that is not scientific rigor. That is institutional failure which undermines public trust.
Patients and physicians need to know FDA approval means it has been deemed “safe and effective” for its use. Sponsors need to know the rules will not change capriciously midstream. Reviewers need to know that if they follow the evidence and the proper process, their leader will stand behind them.
The next Commissioner must also understand that FDA operates in a political world without becoming political itself. FDA is accountable to the public through elected officials. It operates within HHS, under administration, subject to oversight by Congress, and amid pressure from industry, advocacy groups, media, and the public.
But FDA’s own decisions must be based on science and evidence.
There is a critical distinction between FDA making regulatory decisions and political leaders making policy decisions about FDA-regulated products. FDA’s role is to provide a rigorous scientific assessment and deliver an evidence-based judgement as to the safety and efficacy of a product. Elected leaders may choose to act on that assessment in a broader economic, trade, cultural, or political context. FDA can inform but not make those decisions.
For example, administration policies can impact the FDA. During our tenure the President’s Emergency Plan for AIDS Relief (PEPFAR) was initiated. The FDA was impacted by that policy decision requiring the accelerated approval of HIV drugs. The Commissioner’s role was not to simply expedite the policy but first and foremost to assure that the drugs provided were proven by FDA to be safe and effective.
Separating FDA from political issues applied in a quite different case involving small pet turtles. Turtle growers lobbied Congress to secure relief of an FDA rule that prohibited their sale because of the risk of poisoning small children with salmonella. The growers’ proposed solution was to treat the turtles in chlorinated water. FDA scientifically tested their hypothesis. The treatment reduced salmonella immediately after exposure, but the bacteria returned within days after exposure. The public-health risk remained, and the agency refused to change the rule.
In both cases, the correct process was not to make determinations based on politics or an economically advantageous outcome. Nor was it to dismiss participation out of hand. The answer was: make regulatory decisions based on scientific evidence. That is what the next Commissioner must do: Bring the focus back to evidence and affirm the trust that FDA decisions are based on the integrity of scientific evidence in support of promoting and protecting the public’s health.
The next Commissioner must also respect public service. The men and women of FDA do difficult work and make decisions that affect patients, consumers, physicians, companies, markets, and public confidence. They do so, aware that every significant decision will disappoint someone. The Commissioner’s role is to go to Capitol Hill, answer the hard questions, absorb the criticism, explain the decision and defend the process and the people who follow the evidence.
If the process was poor, the analysis incomplete, or the decision inconsistent with FDA’s own standards, the Commissioner must insist that it be remedied and assure the remedy occurs. But when the agency has done the work properly, its leader must stand behind it.
This is not to say the FDA should resist change- but FDA should adapt through deliberation, evidence, transparency, and process. It should modernize because science requires it, not because someone has an instinct, slogan, or theory to impose overnight.
An M.D. degree can be valuable in this role, as can scientific, legal, regulatory, and management experience. But no credential, by itself, guarantees that a commissioner understands the job. The next Commissioner must be judged by whether he or she can protect FDA’s real source of authority: a process in which evidence is heard, science is respected, decisions are consistent, and public servants can do their work.
Tommy G. Thompson served as U.S. Secretary of Health and Human Services from 2001 to 2005 and as Governor of Wisconsin from 1987 to 2001.
Andrew C. von Eschenbach, M.D., served as 20th Commissioner of the U.S. Food and Drug Administration and 12th Director of the National Cancer Institute.
