Inside Health Policy- FDA Watchers Divided Between Woodcock, Sharfstein For Agency Chief

Beth Wang | February 08, 2021

President Joe Biden has yet to name a nominee for FDA commissioner, but policy watchers are making their preferences known, with more than 80 health organizations and advocacy groups backing FDA drug center director Janet Woodcock, who is currently serving as acting FDA chief, and 18 scientists, researchers and policy experts saying they want former FDA Principal Deputy Commissioner Joshua Sharfstein in the role.

Woodcock has been pegged as a potential front-runner for the full-time commissioner position ever since she was named acting agency chief by Biden. Supporters of Woodcock have said she would be a great pick for the full-time commissioner role, as she has decades of experience at FDA, is respected by the agency’s science and policy professionals, and has credibility as a manager. Sources also say Woodcock would work well with former FDA chief David Kessler, who now serves as chief scientific officer of the White House’s COVID-19 Response Team.

However, Woodcock also is facing opposition from some lawmakers, consumer advocacy organizations and anti-opioid groups who cite her history with opioid approvals.

Organizations like Public Citizen have said they support Sharfstein, who’s been eyed as a front-runner for the role for months. He fits the organization’s criteria in that he not only worked at FDA and comes from academia, but he’s also led public health departments.

Over the past few weeks, policy watchers have come out expressing their support for one over the other.

In a Sunday (Feb. 7) letter to the president and his HHS Secretary-nominee Xavier Becerra, more than 80 advocacy and research organizations, including Friends of Cancer Research, the American Association for Cancer Research, National Consumers League and EveryLife Foundation for Rare Diseases, say they strongly support Woodcock in her current role as acting agency chief and her potential nomination for the permanent position.

Woodcock, they say, has been an advocate for patients and consumers and an ally to patient advocacy groups. Her distinguished history as leader at FDA will help the agency meet the challenges presented by COVID-19, including the need for continued development, review and approval of coronavirus vaccines and therapies and assurance that medical products will be able to adapt to new strains of the virus.

The groups highlight Woodcock’s work advocating for more funding for oversight and inspections of overseas drug manufacturing, as well as her efforts to help reform pharmaceutical manufacturing and guide the agency toward a more patient-centered approach.

Under Woodcock’s leadership, the drug center’s regulatory decision-making processes have become more open and transparent to the public, the organizations say. Changes include publishing the center’s regulatory procedures and policies, developing more than 100 technical guidance documents that describe regulatory standards, giving consumer and patient representatives a say in FDA processes, and creating a drug center website that includes drug reviews and consumer information.

“Dr. Woodcock’s 37 years of senior-level experience at the FDA serves as both a touchstone for how to get things done and a master class in understanding the intricacies of the agency’s work,” the letter says. “This earned experience, and the respect that accompanies it, allow her to speak authoritatively on the processes that can be streamlined to ensure a rapid response to public health emergencies while ensuring that the structures that are vital to ensure the FDA’s mission and standards of independence and rigor are upheld.”

Another group of agency watchers is pushing for Sharfstein, who currently serves as vice dean for public health at Johns Hopkins.

The group of scientists, researchers and public policy experts, including Aaron Kesselheim, associate professor of medicine at Harvard Medical School, and Jerry Avorn, chief of Brigham’s Division of Pharmacoepidemiology and Pharmacoeconomics, wrote a letter to Becerra and acting HHS Secretary Norris Cochran saying that Sharfstein has integrity, leadership experience and a broad knowledge base, and that as commissioner he would strengthen FDA’s reputation and ensure the agency’s decisions are science-based and transparent.

Sharfstein also has a “special ability” to dissect complex problems, articulate core issues, and lay out the pros and cons for his recommended actions, the policy experts say. He can see the bigger picture and will work collaboratively to develop a plan.

The letter, dated Friday (Feb. 5), cites examples of Sharfstein’s work, including his efforts in Massachusetts to study the impact housing barriers have on people’s health, which gained attention from former Massachusetts Sen. John Kerry (D). He also worked with hospitals, state agencies and the Massachusetts Governor’s office to ensure emergency rooms provided beds for children and adolescents with mental health problems.

Sharfstein also has extensive knowledge and expertise in areas of importance to FDA, including HIV/AIDS, tobacco, opioids, vaccines, cold medicines, sunscreen, dietary supplements, health care payment systems and off-label marketing, according to the policy experts.

“We are writing this letter because we value the importance of science to the future of our country and we understand how much is at stake,” the letter writers says. “There is no doubt that Dr. Sharfstein has already established himself as a champion for evidence-based medicine and visionary leadership at the highest levels of government. He will bring great credit to the FDA as Commissioner.” -- Beth Wang (bwang@iwpnews.com)

 

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