In a bid to cut bureaucratic red tape and elevate the agency’s importance, a bipartisan coalition of former FDA commissioners called for it to be made an independent federal body and potentially a Cabinet-level organization. It is currently housed under the Department of Health and Human Services (HHS).
The commissioners made their arguments during a discussion at the Aspen Ideas Festival’s Spotlight Health on Saturday, according to Politico. Speakers included nearly every agency chief dating back to President Ronald Reagan’s second term: Frank Young (Reagan appointee); David Kessler (George H.W. Bush appointee); Jane Henney (Bill Clinton appointee); Mark McClellan and Andrew von Eschenbach (George W. Bush appointees); and Margaret Hamburg (Barack Obama appointee).
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Current FDA commissioner Robert Califf was also present but didn’t join his predecessors’ call for an institutional breakup.
The agency chiefs’ recommendation was spurred by frustrations with political and bureaucratic micromanagement which, they argued, runs afoul of the FDA’s science and data-driven mandate to assess the safety and efficacy of foods and drugs. They also pointed to hazy budgetary boundaries that could leave funding up in the air.
“The micromanagement from on top has probably gotten to the point where an independent agency is necessary,” said Kessler, who was FDA commissioner from 1990 to 1997. “There are 150 people in between the commissioner and the president, and they all think they’re your boss. That’s the problem.”
As the gatekeeper of the U.S. drug market, the FDA has often found itself staring down political pressures. Former Obama HHS Secretary Kathleen Sebelius stunned former commissioner Hamburg when she unilaterally overruled FDA scientists’ recommendation that the emergency contraceptive Plan B should be available over-the-counter and without a prescription to girls as young as 11.
Sebelius slapped a 17-year-old age restriction on the prescription-free OTC rule, only to be overturned by a federal judge. The Obama administration eventually reversed its position, but the episode was “very disturbing,” according to Hamburg.
It’s unclear if bureaucratic and political pressures would subside entirely with an independent FDA. Patient and advocate groups lend their voices to the agency’s advisory committee meetings and have used deeply personal testimony and political clout to sway regulators to approve certain products, sometimes to controversial effect.