Crafting an Independent FDA: Former Commissioners Agree

The Aspen Ideas Festival, an annual event hosted by The Aspen Institute, provides a platform to present out-of-the-box thoughts and ideas conceived globally and across disciplines. The festival brings leaders from diverse fields under the same roof, galvanizing a productive exchange among some of the brightest minds. One such thought was about making the FDA an independent regulatory body that does not have to report to the HHS.

Six individuals who have led the FDA over the past 40 years participated in a discussion at Aspen, on the challenges that the agency faces and whether it is equipped enough to do its job. Margaret A. Hamburg, MD; Jane E. Henney, MD; David A. Kessler, MD; Mark B. McClellan, MD, PhD; Andrew C. von Eschenbach, MD; and Frank E. Young, MD, who served through Republican and Democratic presidencies, recommended independence of the FDA—either Cabinet-level powers or autonomy similar to the Federal Trade Commission. They believe this would significantly reduce the harm caused by bureaucracy, political meddling and the lack of clarity with Congressional budgets.

“The FDA is trapped in a structural problem,” said von Eschenbach, who was the FDA commissioner during the Bush administration from 2006 and 2009. The funding structure, he said, lays bureaucratic barriers that shackle the FDA and can delay its response to public health emergencies.

“The micromanagement from the top has probably gotten to the point where an independent agency is necessary,” said Kessler. “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. Hamburg echoed both their feelings.

The former commissioners also expressed frustration on the supposed disconnect between the FDA’s scientific conclusions and the decisions that are finally made that are beyond the FDA’s control. One such example was cited by Henney. She said that a decision on regulating dangerous trans fats that she had signed off on during her tenure as commissioner, took about 8 years to translate into a policy decision. Hamburg voiced her frustration about how the FDA’s recommendation on making the morning-after pill an over-the-counter medication was overruled by then—HHS secretary Kathleen Sebelius.

The next step for the commissioners might be a white paper on the topic, Young said.