President Joe Biden has not yet announced his nominee for Food and Drug Administration commissioner. Reportedly under consideration are Dr. Janet Woodcock, now acting commissioner, and Dr. Joshua Sharfstein, former principal deputy FDA commissioner, now a public health advocate and currently an associate dean at Johns Hopkins Bloomberg School of Public Health.
Who gets to head the FDA will determine the safety and effectiveness of future drugs and other medical products. That’s why some groups are publicly endorsing one or the other candidate for the job.
Dueling letters
On February 5, 18 physicians and public health leaders publicly supported Sharfstein for the job, stating that he “knows the FDA and will ensure that its decision making is scientifically beyond reproach, transparent and based on the principles of public health.”
“This is the first time any of us have endorsed a candidate to be FDA commissioner,” the letter states. But this endorsement was crucial, the letter concludes, “because we value the importance of science to the future of our country and we understand how much is at stake.”
The letter also took a subtle swipe at Woodcock without naming her, but mentioning some of the FDA’s “questionable decisions,” including its approval of the painkiller Vioxx, later linked to thousands of heart attacks and withdrawn from the market by drugmaker Merck; and its much-criticized regulation of opioids, both of which occurred during Woodcock’s tenure as head of the Center for Drug Evaluation and Research (CDER).
A few days later, more than 85 patient and medical provider groups released a letter asserting their support for Woodcock, who has been “an ally to patient advocacy groups, and a fearless leader at the FDA. Dr. Woodcock’s outstanding record of civil service at the FDA has helped transform the agency into one that strives to put patients at the center of its decision-making,“ the letter stated.
The drug industry has been clear about its preference for Woodcock. A recent poll shows that about two-thirds of drug industry insiders would welcome her nomination.
Where are progressive nonprofits?
Largely missing from the public fight are progressive nonprofits that have advocated for reform at the FDA over the years. It appears that only Public Citizen’s Health Research Group has been willing to both oppose Woodcock’s nomination and to praise Sharfstein as the better choice for the job.
Late last month, Public Citizen signed on to a letter asking Biden not to nominate Woodcock. The letter focused on her work as a regulator of opioids, and was also signed by 25 groups representing victim families, and by Physicians for Responsible Opioid Prescribing (PROP).
“Woodcock presided over one of the worst regulatory failures in U.S. history,” the letter charged. “Since 1999, more than 500,000 Americans have lost their lives to opioid-related overdoses, and millions of Americans have developed opioid use disorder from use of prescription opioids.”
The letter added that when taken to task for the FDA’s failures, Woodcock has “maintained a defensive posture.”
Dr. Andrew Kolodny, PROP’s vice president for federal affairs, said that when his group met with Woodcock in 2011, she seemed sympathetic. She told the group that she was a rheumatologist and knew that “opioids are really lousy for chronic pain,” he recalls.
It wasn’t until much later that the group realized how much power she had. She was “the reason we were getting nowhere and nothing is really changing,” he says. “That’s because Woodcock didn’t want it to change.”
Woodcock and the opioid crisis
Woodcock served as head of CDER from 1994 to 2004 and from 2007 through April 2020, when she joined the vaccine team for Operation Warp Speed. Woodcock still maintained a presence at FDA, although she recused herself from overseeing the agency’s approval process for any COVID-19 vaccines or products.
Under her watch, the powerful opioid Oxycontin, used for short-term pain, often in terminal patients, was approved for chronic pain, even though the drugmaker Purdue Pharma had not presented sufficient evidence to prove that it was safe for that type of use or that it would not be addictive. In addition, according to documents that Johns Hopkins public health researchers provided to the New York Times, the FDA did little to prevent wide prescription of powerful fentanyl opioids for a variety of medical conditions. The agency essentially trusted the drug companies profiting from drug sales to ensure the powerful opioid was being used properly. As a result, the drug, approved only for use by cancer patients already on opioids who require fentanyl for sudden excruciating pain, was prescribed to thousands of other pain patients, some of whom became addicted or died from overdose. Imposing stricter controls on the drug companies, Woodcock told the Times, would be “extremely onerous.”
Woodcock fostered a pro-industry culture
But Public Citizen has a far broader critique of Woodcock. “There are many other problems with her leadership ... that go well beyond opioids,” says Dr. Michael Carome, who directs its Health Research Group.
“She is someone who too often acts in the best interest of regulated industry rather than … in the interests of consumers, Carome says. “This is a pattern that has unfolded over the more than 25 years she has directed the drug division.”
Carome singles out a recent controversy, and one that epitomizes the problems with the FDA culture.
It concerns the approval process for a new drug to treat Alzheimer’s disease. Biogen, its lead sponsor, initially stopped clinical trials for the drug because it found little evidence that it worked. A few months later, in “close collaboration with the FDA,” the company “reanalyzed” its data and concluded that the drug worked at certain dose levels, and that it was going to seek FDA approval, Carome says.
When an FDA advisory committee of outside experts convened last November to consider the company’s application for approval of the drug, the experts found something unusual, Carome says. Usually, the FDA produces a briefing document explaining the staff’s review of the drug, and the company produces its own briefing document. But in this case, Carome says, “there was a joint briefing document written by FDA staff and Biogen,” with most of the material expressing “Biogen’s position.”
“The advisory committee members weren’t buying it,” and “were highly critical of the data,” Carome said, adding that members voted overwhelmingly to require another clinical trial. He said that this “was an example where Biogen and the FDA worked hand in hand to try to salvage a drug for which the evidence doesn’t support approval.”
He called this a “tremendous example” of the agency culture that Woodcock fostered, where the drug company is “viewed as a client or customer of the agency that they’re trying to help.”
Pleasing drug companies
“We’re not asserting that she’s corrupt,” he adds. To the contrary, she’s worked at the FDA for 30 years “on a government salary, not being paid by industry.”
But her career has been “closely linked” with the 1992 congressional passage of the Prescription Drug User Fee Act, (PDUFA) which marked “a significant change in the relationship between the FDA and regulated industry,” he says.
The law requires drug companies to pay FDA fees to cover a large portion of the cost of drug reviews. How much the companies pay is subject to negotiation every five years, and the drug industry attaches requirements that concern the “standards and the speed” of drug reviews, Carome explains.
Drug companies pushing for quicker approvals have put pressure on FDA staff to “to make decisions faster. If they have concerns, they might be less inclined to ask questions and ask for more data from the manufacturer.”
The law was implemented shortly before Woodcock joined the FDA, and “with it came more opportunities for meetings between industry and agency officials,” Carome says. Woodcock, he observes, thinks of drug companies as customers “whose needs and interests need to be served.”
“Under Woodcock’s leadership,” he says, “we have seen decision after decision where the data for safety or effectiveness or both was insufficient, in our view, to justify approval, and yet approval occurred.”
Sharfstein’s public health background
In contrast, Sharfstein served only two years at the FDA, and has spent most of his career in public health. Between college and medical school, Carome says, Sharfstein actually worked for Public Citizen’s health research group. His career has included service as an aide to health reformer Rep. Henry Waxman (D-Calif.), and stints as Baltimore’s commissioner of health and Maryland’s secretary of health. He joined Johns Hopkins Bloomberg School of Public Health in 2015.
“He’s someone who... would be much stronger in insisting that evidence of effectiveness and safety” for the agency’s approvals of medical products, Carome says, adding that he could “begin to change the culture” at FDA. Woodcock, he predicts, would push the agency “further in the wrong direction.”
But who gets to head FDA, Carome adds, is really up to the Biden administration. If Biden nominates Woodcock, Congress will approve her, Carome predicts. He points out that many patient groups who lobby Congress for faster drug approvals are funded by the drug industry. So lawmakers hear the same message from patients and from industry advocates. “For independent groups like ours, it is an uphill battle.”
Last month, Democratic Sens. Ed Markey (Mass.) and Maggie Hassan (NH) issued a joint statement opposing Woodcock’s nomination. “[I]t’s important that the next FDA commissioner is someone who has demonstrated that they have learned from the FDA’s past mistakes—not someone who has been involved in repeating them.”
Nevertheless, Carome insists, “If Woodcock were to be nominated, she would absolutely be confirmed. “All Republicans are going to vote for her because industry loves her. You’re not going to have Democrats line up to oppose an early nomination for anyone from the Biden administration.
“There may be a few [senators] in opposition, but they’ll be in the minority,” Carome says. “So we’re seeking to stop the nomination.”
