Woodcock vs. Sharfstein for FDA Commissioner

Woodcock is seen as more pro-industry and favored by patient advocacy groups. Sharfstein's supporters say he would restore integrity to the agency. Sharfstein has proposed reforms to the FDA approval process.

The FDA commissioner’s job in the Biden administration is still open and several news outlets have reported that the president’s likely pick has come down to one of two people: Acting Commissioner Janet Woodcock, M.D., a longtime FDA official, or Joshua Sharfstein, M.D., a vice dean at the Johns Hopkins Bloomberg School of Public Health.

“Woodcock has lent attention to accelerated pathways and incentives for pharmaceutical companies making experimental treatments — including new cancer drug, a priority of Biden’s during and after his service as vice president,” reported CQ Roll Call.

Several dozen consumer and patient advocacy groups were signatories to an Feb. 7 ad in the Los Angeles Times supporting Woodcock for the top job at the FDA. The ad, presented as an open letter to Biden and his pick to become HHS secretary, Xavier Becerra, describes Woodcock as a “passionate advocate for American patients and consumers, an ally to patient advocacy groups, and a fearless leader at the FDA.” Many of the groups that signed the letter are patient advocacy groups for rare diseases, such as One Rare, the Phelan-McDermid Syndrome Foundation, Fabry Support & Information Group and Hermansky-Pudlak Syndrome Network.

But according to the Washington Post, “anti-opioid advocates (have)voiced opposition to Woodcock, saying she and the drug center (at the FDA) she helmed had approved too many opioids over the past two decades.”

Sharfstein is favored by “skeptics of the pharmaceutical industry’s sway at FDA,” according to CQ Roll Call’s reporting.

Roll Call quoted Peter Lurie, president and executive director of the Center for Science in the Public Interest and a former FDA official and a former FDA official as saying, “For me, the single largest contextual matter at the moment is the restoration of the agency’s scientific integrity after the pummeling it took under Trump. For that you need Sharfstein.”

Sharfstein wrote an editorial published in JAMA in January 2020 that described the FDA approval process as “a thicket of special programs, flexible review criteria, and generous incentives.”

Sharfstein proposed a four-point program for reforming the FDA approval process that included rationalizing the agency’s various expedited reviews, including promotion of “meaningful competition for nonorphan uses”; stronger oversight of postmarketing safety; “recalibrating” programs that provide companies with special marketing protections (he mentioned pediatric exclusivity and biosimilars as problem areas that Congress might address); and using “patent and pricing incentive” to push for the generation of definitive evidence for drugs.