The FDA commissioner’s race checks the affect of huge pharmaceutical firms. Hassan rejects lackeys from opioid profiteers in well being
WASHINGTON – A tug-of-war over who should head the Food and Drug Administration at a critical moment has turned into a referendum on how the value of agency experience compares against new perspectives on FDA regulation of the pharmaceutical industry.
The two front runners are Acting Commissioner Janet Woodcock, a 37-year-old FDA official who is viewed as open to approving therapies through accelerated routes, and Joshua Sharfstein, a public health academic, who has concerns about some of the incentives and procedures Industry has voiced for rapid approval. The nomination decision comes as the FDA rushes to review much-needed COVID-19 vaccines and therapies as it recovers from recent flaws in its reputation.
Washington insiders say the promotion of a career official like Woodcock shows that the Biden administration puts science before politics. Woodcock would be the third commissioner.
Woodcock has been looking to accelerate pathways and incentives for drug companies conducting experimental treatments – including new cancer drugs, a priority for Biden during and after his tenure as Vice President. That earned her praise from patient populations whose power has grown under Woodcock’s watch, including those supported by the pharmaceutical industry.
Dozens of patient groups, medical groups and industry groups have called for her nomination in public letters and a newspaper advertisement in the Los Angeles Times in the past few days. More letters are on the way, according to the American Association for Cancer Research.
However, FDA experts say some of these groups are viewed as the mouthpieces of the industry as they often receive high grants from drug manufacturers.
“Patient groups are understandably interested in new therapies and sometimes try to lower the bar in order to bring products to market. You saw Janet as an ally, ”said Peter Lurie, former FDA and Center for Drug Evaluation and Research employee. “The FDA staff treat patient groups like any other stakeholder and do not consider where they are from. Most are at least partially funded by pharmaceuticals. “
Skeptics about the influence of the pharmaceutical industry on the FDA want another candidate. Many support Sharfstein, a former FDA deputy commissioner and House Democrat advisor who has published editorials calling for changes to the agency. They argue that Sharfstein’s appointment could improve the agency’s reputation.
“For me, the biggest contextual matter right now is restoring the agency’s scientific integrity after the Trump pummel,” Lurie said. “You need Sharfstein for that.”
Some analysts say Sharfstein might be more cautious about speeding up drug approval.
“If you read some of the comments he has made and look at some of the things he has been concerned with as deputy commissioner, he has essentially questioned the way Woodcock implemented some of these programs,” said Rob Smith , a healthcare provider analyst at Capital Alpha Partners.
For example, Sharfstein has proposed changing certain incentives to promote rare disease cures that have been rigged over the years to prevent generic competition for common drugs. He has also suggested increasing supervision over drugs that are already on the market but can be dangerous, such as fentanyl. He said the FDA should reassess the granting of longer patent monopolies to certain drug companies, or the reluctance to use these incentives, until companies demonstrate their drug is effective in clinical trials.
Sharfstein supporters insist that scientific rigor and the acceleration of experimental therapies are not mutually exclusive.
“I think the commissioner must continue to ensure that the FDA is at the forefront of the latest science,” said Aaron Kesselheim, a Harvard pharmaceutical expert who signed a letter on behalf of Sharfstein criticizing expedited reviews. “The FDA’s job is to separate the wheat from the chaff.”
One hurdle for Woodcock could be asking for greater accountability from the FDA for decisions that have dramatically expanded the supply of pain relievers in the nation. Proponents, including a coalition that wrote a letter opposing her nomination on Jan. 27, said Woodcock led one of the “worst regulatory failures in US history.”
Woodcock’s critics say she has an inordinate understanding of drug-funded third-party groups who have helped re-engineer analgesic clinical trials to increase their chances of success. The opponents are demanding new leadership, so the agency is reviewing how it rates them.
“I definitely think there could be improvements in some of these experimental cancer drugs. There should be a way for that. But these are narcotics. They don’t cure anything, ”said Emily Walden, Chairwoman of FedUp! A group to raise awareness of opioid addiction.
The US Pain Foundation, a patient advocacy group investigated by Oregon CFO Ron Wyden, was among the groups that signed the ad in the Los Angeles Times earlier this week in favor of her association with the maker of an addictive fentanyl Woodcock.
Lurie said some of the criticism of the FDA’s recent opioid approvals was a “bum,” and he co-wrote an article with Woodcock in 2014 defending the agency’s approval of a controversial opioid. But he also said there was no denying 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 Senator Maggie Hassan, DNH, who sits on the committee that would vote on each candidate.
Hassan said in a statement that she speaks out against any candidate who has not learned from the opioid crisis. Kessler did not respond to an email requesting a comment.
“I don’t think this will affect your candidacy,” said Smith, who pointed out that Woodcock previously testified in Congress about opioids. “This is not a new topic that Biden and his team won’t know about as she hasn’t paid her taxes or has a criminal conviction.”
Experts say Woodcock has some Republican support, so a “no” from Hassan would not be enough to break their confirmatory vote.
Woodcock’s supporters say it is “absurd” to hold a person responsible for the opioid crisis.
“She has been with the agency for over 30 years. If she lacked integrity, she still wouldn’t be there, ”said Margaret Foti, CEO of the American Association for Cancer Research.
Whether or not she was named head of the agency, experts say Woodcock will likely continue to have a lot of influence until she retires. Experts say commissioners often postpone important decisions for her anyway.
“It’s true that she has an oversized role in the agency,” Lurie said.
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