6 Ex-FDA Heads Urge Cabinet-level Status for Independent Agency
A panel of six former FDA commissioners, who combined have 32 years of FDA leadership experience, told an Aspen Institute/Atlantic magazine conference 6/25 they strongly believe the agency should be independent and not housed under Health and Human Services, and that it should operate under a model used by the Federal Reserve System and Securities and Exchange Commission. The panel was assembled at the Aspen Ideas Festival in Aspen, CO and included Margaret Hamburg (2009-2015), Andrew von Eschenbach (2006-2009), Mark McClellan (2002-2004), Jane Henney (1999-2001), David Kessler (1990-1997) and Frank Young (1984-1989).
Kessler said it was “very remarkable” that they all agreed an independent agency is needed. By watching from afar the last 10 years, the micro-management from top layers of the current administration in power “has gotten to the point where an independent agency is necessary,” he said. Most major rules over the past few years that have published were the outcome of “someone suing the agency to get them out and that is no way a government should work. There are about 150 people between the commissioner and the president, and they all think they are your boss — and that is the problem. The amount of micro-managing has gotten to the point where it needs to be addressed. The president needs to trust their secretary and their agency heads to do their job, and that trust has not been there.”
To illustrate her support for an independent FDA, Hamburg recalled the “Plan B morning after contraceptive controversy,” where HHS overruled FDA’s approval recommendation to move the product to over-the-counter status. She said it was the first time an HHS secretary had overturned an FDA decision, and it was “very disturbing, particularly because it was precedent setting.” She had considered resigning in protest, “but my feeling was not to leave FDA rudderless and there were many other battles to fight.”
Hamburg noted that the level of engagement by HHS and other officials has increased with each administration. Some of this is attributed to 24-our news cycles and blogs, which makes administrations want to control things more. “FDA makes news every day and it can be controversial at times,” she said, adding that more and more “sign offs” are required for guidances, regulations, press releases, health advisories, and public engagement opportunities.
Likewise with Young. He said he was pressured during his tenure by the administration’s Office of Management and Budget on a “treatment IND” regulation. OMB wanted it to be based on a promise of effectiveness and safety, and the agency objected. Young said he threatened to resign and the agency’s argument prevailed. “We have all had such interferences with, at times, no opportunity to defend the agency,” he said. Young also recommended that an FDA commissioner should have at least a six-year term so that the term “transcends” the next administration. Also, there needs to be a mechanism for the commissioner to have authority to meet with the president, he said.
Voicing his support, von Eshenbach said FDA should have a cabinet-level presence, much like the Environment Protection Agency, because almost everything the agency does somehow interacts with another or several cabinet-level work areas (Trade, Commerce, Defense Agriculture) “and you need that ability to interact at that level.” Another problem is that FDA is trapped in a structural problem, because it is part of HHS but is overseen by Agriculture due to the budget process.
Asked what the six could do collectively next to advance the proposal for an independent FDA, Young said there already has been some talk of them issuing a white paper to guide its direction. Henney acknowledged that there is a “prime opportunity with a new administration coming in next year, where “they will need to make critical decisions on how to run their administration and reorganize how the executive side will work. The new administration can begin taking steps to implement such a suggestion. But there are some pivotal things that could make FDA more effective, and this is one of them.”
Asked to comment on the drug approval system and whether user fees raise a troubling question of who is the client, the public or industry? Henney dismissed the notion: “What is purchased is the review and not the approval. Companies are not gaining leverage on approvals, which rests with the scientific evidence and the legal framework that it is based on.”
Asked to comment on what FDA does not do well, Kessler emphatically said food safety. “The enforcement of food and implementation of the food safety law, and the GRAS [generally recognized as safe] list is a joke,” he said. Also, Kessler questioned the 510(k) process for clearing medical devices. “This may have been useful in 1978, but four decades later to use that as the framework for 98% of medical devices is questionable.” He said the 510(k) process is broken, and there are structural issues that need to be addressed.
To view a video of the panel discussion, click here.