Free the FDA from overweening HHS bureaucracy, ex-agency chiefs say

FDA

The U.S. Food and Drug Administration needs more power. Or it needs more autonomy. Either way, the FDA needs to come out from under the Department of Health and Human Services.

That’s according to 6 former agency commissioners, appointed by Democratic and Republican presidents alike. Speaking at the Aspen Institute’s annual “big vision” gathering, the ex-FDA chiefs said the agency is hamstrung by layers of bureaucracy and interference from higher-ups.

Drug and device makers are familiar with delays reportedly caused by roadblocks at HHS. Agency insiders have said that a variety of FDA guidelines long-awaited by drug and device companies were held up in the HHS bureaucracy. Just last month, the House Energy and Commerce Committee fired off a letter to HHS chief Sylvia Burwell, accusing her department of dragging its feet on new guidelines for off-label marketing. 

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At the Aspen meeting, the former commissioners also cited HHS roadblocks. “The micromanagement from on top has probably gotten to the point where an independent agency is necessary,” according to David Kessler, who served as FDA commissioner under Presidents George Bush and Bill Clinton. “There are 150 people in between the commissioner and the president, and they all think they’re your boss--that’s the problem,” he added (as quoted by Politico).

Ranging from the most recent ex-commish, Dr. Margaret Hamburg, all the way back to the Reagan era’s Dr. Frank Young, all six agreed that some major restructuring is sorely needed. They suggested two potential approaches: Making the FDA a cabinet-level agency, or turn it loose as an independent regulator, like the Federal Trade Commission, Politico reports.

The group is considering writing a white paper outlining their concerns and ideas, Politico says.

To illustrate decisionmaking that frustrated the agency's efforts, Hamburg cited an HHS decision during her tenure. The FDA had recommended that morning-after birth control be made available over the counter, but HHS Secretary Kathleen Sebelius overruled that recommendation.

The off-label marketing guidelines, triggered by recent Supreme Court decisions, are another episode of FDA-HHS bickering, the Energy and Commerce committee leaders said in their letter to Burwell.

“It has come to the committee’s attention that such inaction may be the result of disagreements between FDA and HHS leadership,” stated the letter, signed by committee chairman Fred Upton and subcommittee on health chair Joseph Pitts. “Specifically, despite being on FDA’s guidance agenda since 2014, it is our understanding that HHS has not allowed FDA to issue its completed draft guidance addressing the scope of permissible ‘scientific exchange.’”

- get the Politico story

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