The Biden White House has yet to name a permanent FDA head, although two main candidates for the job have emerged: the FDA’s acting commissioner and FDA veteran Dr. Janet Woodcock and public health advocate Dr. Joshua Sharfstein.
On March 2, the National Black Church Initiative (NBCI), a coalition of 150,000 African-American and Latino churches representing 27.7 million African-American and Latino churchgoers, weighed in. The group strongly urged the administration to name Sharfstein to the agency’s top job, largely because of his advocacy for greater equity in healthcare and his recognition of the impact of racial inequality on public health.
A tipping point?
The insertion of health equity into the discussion and concerns about the FDA’s failure to ensure racial and ethnic diversity in clinical trials may represent a tipping point in the selection process. (See our previous coverage: “Behind the Fight Over Biden’s Choice for FDA Head.”)
In their letter to Xavier Becerra, President Joe Biden’s choice to head the Department of Health and Human Services, the Black religious leaders praised Sharfstein for his “inclusive, culturally sensitive approach to public health,” which, they predict, “will produce appropriate and effective approaches of action in the ever-changing environment of the pandemic.
“[S]o many medical treatments approved by the FDA have not been studied on enough African Americans and Latinos to determine if their benefits outweigh their risks,” the letter pointed out, a situation making it “impossible” for their physicians to “make informed decisions about the best options for their medical care. We believe Dr. Sharfstein will be sensitive to these issues and will do more to ensure minority representation in studies submitted to the FDA for review.”
Rev. Anthony Evans, NBCI’s president, told Blue Tent via email that Sharfstein is “willing to listen to the deep concerns of the black community in relation to racial health disparities” and recognizes the importance of using regulatory and legislative tools “to compel the pharmaceutical industry to stop talking about clinical trial diversity and start making it a reality for all Americans.”
“I think it is very interesting that Dr. Sharfstein is getting support from groups that don’t usually weigh in on FDA commissioner decisions,” noted Diana Zuckerman, president of the National Center for Health Research. Responding by email, Zuckerman, a longtime advocate for more oversight of drugs and devices at the FDA, wrote that NBCI isn’t wrong in its assessment: “[T]here’s every reason to believe that Dr. Sharfstein would be more proactive in ensuring that the benefits of medical products are proven to outweigh the risks for a more diverse group of patients and consumers.”
25 years of frustration
NBCI has spent years trying to achieve these reforms. In 2017, the group reached out to Trump FDA Commissioner Dr. Scott Gottlieb. In its letter to the newly appointed FDA head, the group, advised by African-American physicians, also included detailed recommendations to reform the process.
NBCI leaders complained that their efforts to work with federal regulators and drug companies to make clinical trials more inclusive had been rebuffed by both the industry and the National Institutes of Health.
Its 2017 letter spoke of “25 years of deep frustration” and its recognition that meaningful participation of people of color in clinical trials would occur only “through [FDA] regulations to compel the pharmaceutical industry” to intensify its efforts to recruit a more diverse clinical trial pool.
Woodcock’s allies and critics
Woodcock has the support of many drug company executives. Her fans also include patient groups, many of them financially supported by the pharmaceutical industry, which want the FDA to accelerate its pace of approving new drugs and treatments for a variety of medical problems.
Woodcock’s more than 30-year tenure at FDA has been mostly spent as head of the agency’s Center for Drug Evaluation and Research. In that capacity, she worked with drug companies to speed up the time for drugs to secure FDA approval.
Woodcock’s supporters haven’t been shy about endorsing her. Last month, more than 85 patient groups and medical providers endorsed Woodcock in a full-page ad in the Los Angeles Times. An accompanying op-ed published in the same issue of the paper also praised her. Ellen Sigal, chair of Friends of Cancer Research, a group funded in part by the drug industry, contended that “no individual is better positioned to navigate the pandemic and take the agency forward than the person leading the FDA right now.”
But families of opioid victims have a far different perspective. These groups sent a letter to administration officials blaming Woodcock’s lax regulation of addictive prescription painkillers for the opioid crisis, and calling her unfit to head FDA. That letter was also signed by Public Citizen and Physicians for Responsible Opioid Prescribing.
Three Senate Democrats—Sens. Maggie Hassan (N.H.), Ed Markey (Mass.) and Joe Manchin (W.Va.)—also have faulted her failure to better regulate opioids.
Will progressive values prevail?
Sharfstein spent nearly two years during the Obama administration as FDA deputy commissioner, where he oversaw an investigation of a knee implant whose fast-tracked approval ultimately had to be revoked by the agency.
His progressive bona fides include a stint between college and medical school working with Public Citizen and his tenure as an aide to Rep. Henry Waxman (D-Calif.) He later described that position as “a four-year immersion course in health policy and politics,” helping Waxman use his oversight powers to prod the FDA and other agencies to better protect the public.
Sharfstein served as Baltimore’s commissioner of health, and then as Maryland’s secretary of health and mental hygiene. He’s been vice dean of Johns Hopkins Bloomberg School of Public Health since 2015.
Sharfstein hasn’t had Woodcock’s high-profile endorsements, but he’s garnered some significant support. Eighteen physicians and public health leaders—many of them from well-respected academic institutions—came out publicly in support of his nomination.
Dr. Michael Carome, director of Public Citizen’s Health Research Group, said Sharfstein “would be much stronger in insisting that evidence of effectiveness and safety” drive the agency’s approvals of medical products, adding that he could “begin to change the culture” at FDA.
And Sharfstein hasn’t been reluctant to discuss the public health implications of the pandemic in the media.
He’s spoken forcefully about the importance of public health efforts “preventing people from getting COVID in the first place.” He pointed out that in the U.S., only three cents of every dollar spent on health goes to public health initiatives.
Writing in the Washington Post late last month, he called on Maryland Gov. Larry Hogan to better address vaccine inequities, noting that white residents in the state were twice as likely to be vaccinated as Black residents, with even fewer shots going to Hispanic residents. “The confusing rollout of coronavirus vaccines in Maryland is raising serious concerns of transparency and fairness,” he charged.
