Patient groups and medical product developers are calling on President Joe Biden to quickly nominate a permanent FDA commissioner, and many are taking sides in a competition that they believe has come down to two candidates: Janet Woodcock, whom Biden named as acting commissioner, and Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health.

Nominating and ensuring speedy Senate confirmation of permanent agency leaders, including at FDA, is the first element in a blueprint for “100 days of innovation” released by BIO. The trade association has not publicly backed a specific candidate.

“We need to have a commissioner named, it is already overdue,” Michelle McMurry-Heath, president and CEO of BIO, told BioCentury. Senate-confirmed leadership is important for public confidence in the agency and to advance policies that will be essential during the pandemic and beyond, she said.

While FDA has often been led by acting commissioners, they historically have less authority and command less respect from Congress than a permanent commissioner, McMurry-Heath said.

The need to stabilize morale and rebuild public confidence in FDA after the tumultuous tenure of former Commissioner Stephen Hahn, which featured a series of missteps involving COVID-19 emergency use authorizations and battering of staff and leadership by former President Donald Trump, bolsters the case for quickly nominating and confirming a permanent commissioner.

LINING UP BEHIND WOODCOCK

More than 80 rare disease advocacy groups have signed a letter to Biden applauding his decision to name Woodcock acting FDA commissioner and requesting that he appoint her to the job on a permanent basis.

The letter, sent on Jan. 21, described Woodcock’s three decades of experience at FDA and said she is “the pressure tested leader we need to bring the country out of the Public Health Emergency and lead the agency into the future to improve the health of all Americans.”

The rare disease groups called Woodcock “a strong leader with vision, passion, and experience,” and said that she “has innovated a paradigm shift in therapeutic development, infrastructure, and stakeholder engagement within the ecosystem that has yielded robust development pipelines in disease areas with significant unmet need.”

Ellen Sigal, founder and chairperson of Friends of Cancer Research, told BioCentury that Woodcock’s

“qualifications to run the FDA at this vital moment are unimpeachable. She has always been straightforward in her belief in science, innovation and the important role FDA plays in the lives of patients.”

Woodcock has worked closely with key players in Biden’s orbit, including Eric Lander, Biden’s science adviser and director of the White House Office of Science and Technology Policy, NIH Director Francis Collins, and National Institute of Allergy and Infectious Diseases Director Anthony Fauci. She stepped away from FDA to lead therapeutics development on Operation Warp Speed

LINING UP AGAINST WOODCOCK

While she is strongly endorsed by patient groups, and behind the scenes by many biopharma companies, Woodcock has attracted the enmity of some groups that are influential in the Biden White House and on Capitol Hill.

In a Jan. 27 letter, Public Citizen and 27 other public interest groups wrote to HHS Secretary-designate Xavier Becerra expressing their “strong opposition” to Woodcock’s nomination.

The letter lays much of the blame for the opioid abuse epidemic at her feet, asserting that as director of FDA’s Center for Drug Evaluation and Research, “for more than 25 years, Dr. Woodcock presided over one of the worst regulatory agency failures in U.S. history.”

Public Citizen and the other groups wrote that if she is “nominated for and confirmed as FDA Commissioner, all hope will be dashed that the FDA would begin to base opioid decisions on the best available science.”

In addition to the opioid issue, Senate Democrats are being lobbied to oppose Woodcock by politically liberal groups that believe she has not been sufficiently adversarial to drug developers, and that she impeded approval of emergency contraceptives.

SUPPORTING SHARFSTEIN

Sharfstein’s supporters have launched public and private campaigns on his behalf.

Daniel Carpenter, a professor of government at Harvard University who has written about the politics and history of FDA, and Gregg Gonsalves, assistant professor at the Yale School of Public Health, wrote a commentary making the case for Sharfstein, highlighting his experience as principal deputy commissioner during the Obama administration, as well as his public health orientation.

In addition to his service at FDA, Sharfstein’s resume includes serving as secretary of the Maryland Department of Health and Mental Hygiene in 2011-14 and as health commissioner of Baltimore earlier in his career. 

Sharfstein led transparency initiatives during his tenure at FDA, and at Johns Hopkins he has been an advocate for increased access to opioid-abuse medication.

Sharfstein’s allies in the Biden administration include David Kessler, the former FDA commissioner who replaced Moncef Slaoui as scientific adviser to the government’s COVID-19 medical countermeasures development initiative.

https://www.biocentury.com/article/633821?editionId=ckkhqmca87doo0b29yu…