Corrected Feb. 17 | A tug of war over who should lead the Food and Drug Administration at a critical moment has become a referendum on how the value of agency experience stacks up against new perspectives on how the FDA should regulate the pharmaceutical industry.

The two front-runners are acting Commissioner Janet Woodcock, an FDA official of 37 years viewed as open to approving therapies through accelerated pathways, and Joshua Sharfstein, a public health academic who has expressed wariness about some industry incentives and procedures for fast-tracking approvals. The nomination decision comes as the FDA rushes to review desperately needed COVID-19 vaccines and therapies while recovering from recent blemishes to its reputation. 

Washington insiders say the promotion of a career official like Woodcock would demonstrate that the Biden administration is putting science before politics. Woodcock would be the third female commissioner.

Woodcock has lent attention to accelerated pathways and incentives for pharmaceutical companies making experimental treatments — including new cancer drugs, a priority of President Joe Biden’s during and after his service as vice president. That earned her praise from patient groups whose power has grown under Woodcock’s watch, including those backed by the pharmaceutical industry.

Dozens of patient groups, physician groups and industry groups have called for her nomination in recent days in public letters and a newspaper ad in The Los Angeles Times. More letters are on the way, according to the American Association for Cancer Research.

But FDA experts say some of these groups are viewed as industry mouthpieces, given that they often get large grants from drugmakers. 

“Patient groups are quite understandably interested in seeing new therapies and sometimes seek to lower the bar to get products to market. They’ve seen Janet as an ally,” said former FDA Associate Commissioner Peter Lurie. “People at the FDA treat the patient groups like any other stakeholder and don’t take into account where they are coming from. Most are funded at least in part by pharma.” 

Skeptics of the pharmaceutical industry’s sway at FDA want another nominee. Many support Sharfstein, a former principal deputy FDA commissioner and House Democratic aide who has published editorials calling for agency changes. They argue that the appointment of Sharfstein could improve the agency’s reputation. 

“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,” Lurie said. “For that you need Sharfstein.”

Some analysts say Sharfstein could be more wary of accelerating drug approvals. 

“If you read some of the op-eds he’s written and you look at some of the things he was engaged in as deputy commissioner … he has essentially questioned the way Woodcock has implemented some of these programs,” said Rob Smith, a health care analyst with Capital Alpha Partners.

For instance, Sharfstein has proposed changing certain incentives to encourage rare disease cures that have been manipulated over the years to prevent generic competition for common drugs. He has also proposed increasing oversight of drugs that are already on the market but can be dangerous, like fentanyl. He has said the FDA should reevaluate granting longer patent monopolies to certain pharmaceutical companies or withholding these incentives until companies prove that their drug is effective in clinical trials.

Sharfstein backers insist scientific rigor and speeding experimental therapies are not mutually exclusive. 

“I think that the commissioner will have to continue to make sure the FDA is on the vanguard of cutting-edge science,” said Aaron Kesselheim, a Harvard pharmaceuticals expert who signed a letter in favor of Sharfstein, who has criticized expedited reviews. “The FDA’s role is to separate the wheat from the chaff.” 

FDA and the opioid crisis

One hurdle for Woodcock could be calls for greater FDA accountability for decisions that dramatically expanded the nation’s supply of painkillers. Advocates, including a coalition that wrote a Jan. 27 letter opposing her nomination, say Woodcock presided over one of the “worst regulatory agency failures in U.S. history.” 

Woodcock’s critics say she was overly sympathetic to third-party groups funded by the pharmaceutical industry that helped redesign analgesic clinical trials in a way that boosted their chances of success. The opponents are calling for new leadership so the agency reexamines how it evaluates them. 

“I definitely think there could be improvements with some of these experimental cancer drugs. There should be a pathway for that. But these are narcotics. They’re not curing anything,” said Emily Walden, chair of FedUp!, a group that draws attention to opioid addiction.

The U.S. Pain Foundation, a patient advocacy group that has been probed by Senate Finance Chairman Ron Wyden of Oregon for its connection to the maker of a highly addictive fentanyl, was among the groups that signed on to the ad this week in the Los Angeles Times in favor of Woodcock. 

Lurie said some of the criticism of recent FDA opioid approvals is a “bum rap,” and he co-authored a 2014 article with Woodcock defending the agency’s approval of a controversial opioid. But he also said it’s undeniable that mistakes were made under Woodcock’s watch. 

High-profile critics of FDA opioid approvals under Woodcock include White House vaccine czar David Kessler, a former FDA commissioner, and Sen. Maggie Hassan, D-N.H., who sits on the committee that would vote on any nominee.  

Hassan said in a statement that she opposes any nominee who has not learned from the opioid crisis. Kessler did not respond to an email requesting comment. 

“I don’t think it will sink her candidacy,” said Smith, who pointed out that Woodcock has testified to Congress on opioids before. “This is not a new issue that Biden and his team aren’t going to know about, like she hasn’t paid her taxes or has a criminal conviction.”

Experts say Woodcock would be supported by some Republicans, so a “nay” from Hassan wouldn’t be enough to doom her confirmation vote. 

Woodcock’s backers say that holding any one person responsible for the opioid crisis is “absurd.”

“She’s been at the agency for over 30 years. If she lacked integrity, she wouldn’t still be there,” said American Association for Cancer Research CEO Margaret Foti.

Regardless of whether she is appointed to lead the agency, experts say Woodcock is likely to continue to have a lot of sway until she retires. Experts say commissioners often defer to her on key decisions anyway.

“That’s true that she has an outsized role in the agency,” said Lurie. 

This report was corrected to accurately describe Peter Lurie’s association with the FDA.