Former commissioners call for an independent, autonomous, more powerful FDA

Former FDA commissioners have called for Congress to give the agency more autonomy. The commissioners believed that micromanagement and a lack of access to the president negatively impact public health by hamstringing the agency’s ability to make decisions and implement rules. Other agencies or individuals have the authority to block the FDA’s decisions, which are supported by scientific discovery and extensive research.

Unanimous

The six former commissioners spoke at a panel in Aspen, Colorado, at the Aspen Ideas Festival. Dr. Frank Young (1984-1989), Dr. David Kessler (1990-1997), Dr. Jane Henney (1999-2001), Dr. Mark McClellan (2002-2004), Dr. Andrew von Eschenbach (2006-2009) and Dr. Margaret Hamburg (2009-2015) all raised their hands when asked if the FDA should escape the constraints of HHS. When asked, the panelists offered various examples from their tenures to support the need for an improved decision-making process.

A stronger presence

Von Eschenbach believes that the agency should have a Cabinet-level presence, while not actually being part of the Cabinet, similar to the Environmental Protection Agency. He stated that the FDA’s areas of governance are so broad that they interact with nearly every other area of government and the country’s interests, such as trade, commerce, defense, state relations, and agriculture, and that it only makes sense to have a stronger presence. In addition, the FDA gets its budget from the U.S. Department of Agriculture but is overseen by HHS, resulting in unnecessary difficulty obtaining funding for projects, such his mission to improve the information technology (IT) infrastructure to better track imports.

Too many bosses

Kessler’s arguments for autonomy focused on micromanagement. He pointed out that there are 150 government officials between the commissioner and the president and that every person up the chain views themselves as the FDA commissioner’s boss. He felt that there was not enough trust in the agency heads to allow them to properly do their job.

Hamburg offered an example of the agency’s inability to see its recommendations come to pass: availability of Plan B contraception. The company offering the drug had completed all of the studies, the FDA closely reviewed the scientific evidence, and a strong recommendation was made to offer the drug over-the-counter (OTC) to improve access. Then-HHS Secretary Kathleen Sebelius overruled the recommendation. Hamburg’s concerns extended beyond this one decision, and she expressed that this set an unwanted precedent and was an example of the high level of oversight surrounding every decision. She noted that nearly everything issued by the FDA was required to be approved by someone higher up.

Follow up

The former commissioners discussed uniting to create a white paper containing their agreed-upon recommendations to present to the next administration. Hamburg felt that the new administration will not tackle this issue soon after taking office, but agreed that it was critical to start the discussion, identify the pressing issues, and assist the legislature in creating workable solutions.