New Leadership for FDA Entangled in Politics

The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates. Consumer representatives have pressed to name Joshua Sharfstein to the job, a step up from serving as FDA principal deputy commissioner during the Obama administration; research and patient organizations seek to retain acting commissioner Janet Woodcock as permanent head of the agency. The administration’s inaction so far has set up the current situation as an unofficial trial period for Woodcock to display her leadership ability and political savvy as pressures continue for resolving the coronavirus pandemic.

A main claim against Woodcock is that she didn’t do enough to keep dangerous opioid treatments off the market in her long stint as director of the Center for Drug Evaluation and Research (CDER), and that she too often champions industry interests. Several leading scientists and consumer groups back Sharfstein as best able to balance public health with industry regulation.¹ At the same time, more than 80 health and research organizations have called on Biden to name Woodcock to the top job based on her deep understanding of how the complex and vital agency works after 37 years at FDA.^2,3 Sharfstein, previously Maryland public health commissioner and now a dean at Johns Hopkins University, appears more of a reformer, which makes industry nervous but pleases many Democrats.

Other names have emerged as possible candidates to lead FDA, including previous agency officials Amy Abernathy and Luciana Borio. Former FDA commissioner David Kessler dropped out of the running when he agreed to serve as scientific leader of the Biden administration’s pandemic countermeasures program, which will involve key FDA initiatives in new drug development, expanded manufacturing and vaccine delivery.

Confirmation battle brewing

One factor underlying the current debate is a mounting confrontation on Capitol Hill over confirmation of the administration’s choice to head the Department of Health and Human Services (HHS). The Senate appears headed for a contentious debate over the appointment of California attorney general Xavier Becerra to lead the department. Republicans criticize Becerra for contributing to California’s failures in combatting the pandemic in California, which has led to lawsuits and strong pushback in that state. Conservatives also oppose his support for abortion rights, for “Medicare for All,” and for expanding Medicaid.

At the same time, Becerra has alienated the pharmaceutical industry by siding with hospitals in the debate over 340B drug discounts and championing a range of drug price control proposals. His background in public health and the greater urgency to address the pandemic is expected to focus his attention more on health care coverage and access issues, and less on overseeing biomedical research and regulatory policy.

Meanwhile, Woodcock is busy at FDA preparing policies to facilitate the speedy review and approval of revised vaccines and medical products to address rapidly spreading COVID-19 variants. FDA also is readying its analysis of the new COVID-19 vaccine from Johnson & Johnson in preparation for the upcoming advisory committee review hearing in two weeks, and more new coronavirus vaccines and therapies are moving through clinical testing. The use of Emergency Use Authorizations (EUAs) to permit patient access to these innovative treatments will face further scrutiny as the pandemic winds down.

At the same time, FDA is under continued pressure to meet timeframes for approving the many non-COVID medical products moving through the R&D pipeline and to address shortages in vital ingredients and medicines aggravated by the pandemic. A recent agency decision to put off approval of a controversial Alzheimer’s drug will have to be revisited. FDA also is in the midst of negotiating renewed user fees with industry, which have to be approved by Congress through legislation that regularly provides a vehicle for wide-ranging reforms and new FDA initiatives. Woodcock has long championed policies to modernize drug manufacturing and to create a more efficient and effective clinical research system in the U.S., and these efforts have gained added impetus from pandemic pressures.

A main assignment for FDA’s new commissioner will be to restore the agency’s independence and reputation for relying on science in regulatory decisions in the wake of very public attacks on its authority by Trump administration leaders. These pressures on FDA, particularly in the last days of the former administration, has turned up the volume on calls for FDA to be an independent agency, separate from HHS. It is clear that FDA will remain in the spotlight for months to come, and strong, permanent leadership is needed sooner, rather than later.

Notes

1. https://www.statnews.com/2021/01/24/high-stakes-choosing-right-fda-commissioner/

2. https://friendsofcancerresearch.org/news/right-leader-fda-time-crisis

3. https://pink.pharmaintelligence.informa.com/-/media/supporting-documents/pink-sheet/2021/02/dr-woodcock-rare-disease-community-letter-2521.pdf