Six former commissioners say FDA should be independent agency

ASPEN, Colo. — Give the FDA independence and elevate its status. That’s the message from six former commissioners who led the FDA for a combined 32 years.

The FDA is currently part of the Department of Health and Human Services (HHS). Making it a Cabinet-level organization or finding another way to give it more autonomy would be a step in the right direction for public health, the former commissioners argued.

The newly confirmed FDA commissioner, Dr. Robert Califf, listened to their arguments but declined to comment on their call to elevate the stature of the FDA.

Dr. David Kessler, who headed the FDA from 1990 to 1997, complained of “micromanagement from the top.” He pointed out that there are about 150 people between the FDA commissioner and the president.

“They all think they’re your boss, and that’s the problem,” Kessler told a packed audience at Spotlight Health, part of the Aspen Ideas Festival.

That’s been a longstanding problem, said Dr. Frank Young, who led the agency from 1984 to 1989. “I could get to the vice president, but I could never get to the president,” said Young, who was appointed FDA commissioner by President Ronald Reagan.

Other former FDA commissioners speaking on the topic were Dr. Jane Henney (1999 to 2001), Dr. Mark McClellan (2002 to 2004), Dr. Andrew von Eschenbach (2006 to 2009), and Dr. Margaret Hamburg, (2009 to 2015). They were appointed by Presidents George H.W. Bush, Bill Clinton, George W. Bush, and Barack Obama.

All expressed frustration that decisions had made at levels above the FDA that were not supported by science and ran counter to what the FDA’s staff had concluded.

Henney said she signed off on a decision to regulate dangerous trans fats. But it wasn’t until Hamburg was named commissioner, eight years after Henney’s term ended, that the policy was put in effect.

Hamburg recounted a time when the FDA strongly recommended that the morning after pill — a form of emergency contraception — be made available over the counter without a prescription. The decision was overruled by then-HHS secretary Kathleen Sebelius.

“It was very disturbing,” Hamburg said, noting it was the first time a health secretary had overturned an FDA recommendation.

During von Eschenbach’s term, the FDA was asked to determine if milk from cloned cows should be allowed into the US milk supply. Agency scientists could find no scientific difference between milk from regular cows or cloned cows, he said. But if the milk had been allowed into the national supply, exports of American cheese would have been frozen out of the European market.

The FDA should be at the cabinet level so it can contribute more to decisions on interests like these, he said.

The fact that the call for FDA independence comes from six former commissioners who were appointed by Republican and Democratic presidents ought to strengthen its impact, said Young.

This is the first time the group has made the recommendation publicly, Young said, and suggested that the next step may be to write a white paper for the next US administration.