Kessler, Sharfstein in the Running for FDA Top Post

Speculation is growing as to who will be selected as FDA commissioner under the incoming Biden Administration, and two familiar names are circulating the rumor mill. Former commissioner David Kessler (11/8/1990 to 2/28/1997) and former principal deputy commissioner Joshua Sharfstein (2009–2011) are reportedly top contenders.

Kessler, if he wants the post, currently has an inside track for another government run. The former commissioner is currently co-chair of Biden’s advisory board on the coronavirus pandemic. During his previous tenure, Kessler slashed the agency’s approval time for AIDS therapies and he spearheaded its activities to regulate the tobacco industry — an ongoing top concern of his.

Kessler has joined other former commissioners in criticizing the Trump Administration’s handling of the coronavirus pandemic (see earlier story). Writing in a Washington Post op-ed earlier this year, he and six other former FDA commissioners warned that the perception of political influence in FDA’s science-based decisions is a serious concern, saying “political intrusion only prolongs the pandemic and erodes our public health institutions.” The seven said that a Covid-19 vaccine is urgently needed to reduce the virus’ health impacts and help the country return to normalcy. “But a safe and effective vaccine will not be enough,” they wrote. “People will also have to choose to take it. This depends on widespread confidence that the vaccine approval was based on sound science and not politics. If the White House takes the unprecedented step of trying to tip the scales on how safety and benefits will be judged, the impact on public trust will render an effective vaccine much less so.”

Sharfstein is the current vice dean for public health practice and community engagement at Johns Hopkins Bloomberg School of Public Health. He too has been a vocal critic of the Trump Administration’s assault on science. During his time at the agency, he was instrumental in advancing transparency in its regulatory decision making, but that stalled after he left FDA. He recently wrote that “Public confidence in FDA during the Covid-19 pandemic would be improved with greater transparency of the data and the reasoning on which it bases these and other complicated decisions.”

Earlier this year, Sharfstein said there were four things FDA and Congress should do to enhance the benefits and value and reduce the inefficiency and risks of the U.S. system of drug approval (see story). Sharfstein’s ideas appeared in a JAMA editorial accompanying a research article discussing the evolution of drug approval in the U.S. over several decades. According to Sharfstein, the picture is not of a struggling FDA but rather of a regulatory process that has evolved over time into a thicket of special programs, flexible review criteria, and generous incentives. He suggested that: 

• Congress and FDA rationalize the various programs for expedited review to, at least, promote meaningful competition for non-orphan uses and update requirements for fast track and breakthrough status to increase the chance the treatments will be shown to offer major advances for patients;
• FDA should strengthen its oversight of postmarketing safety for medications that offer major benefits but also pose serious risks;
• Congress should recalibrate the programs that provide companies with special marketing protections; and
• Congress should use patent and pricing incentives to accelerate the generation of definitive evidence under accelerated approval.