Presented by

With Megan R. Wilson

WOODCOCK SET TO RETIRE — Longtime FDA regulator Janet Woodcock, who has worked at the agency since 1986, plans to retire in early 2024, FDA Commissioner Robert Califf told agency staff Thursday.

Califf’s all-hands email to FDA staff came hours after POLITICO first reported the news of Woodcock’s retirement plans.

The regulator — who close watchers of the agency describe as a tour de force — most recently has served as principal deputy commissioner.

“A legend in every sense of the word, Janet has made an indelible mark on so many of us, and on public health,” Califf said in the email.

During the pandemic, Woodcock helped spearhead the government’s work on Covid-19 therapeutics — a role she stepped into after leading the FDA’s Center for Drug Evaluation and Research for the second time.

“No part of the agency is untouched by her energy, determination and vision,” Steven Grossman, executive director of the advocacy group Alliance for a Stronger FDA, said.

Near the end of the Obama administration, Woodcock faced criticism for her support of Sarepta Therapeutics’ drug for Duchenne muscular dystrophy, which was approved despite opposition from FDA staff reviewers.

Trump-era FDA Commissioner Scott Gottlieb praised the longtime drug regulator for her role in shaping regulatory pathways for drug approvals in areas including antibody drugs and cancer therapies.

“She made enduring improvements in FDA’s operations that set a global standard, creating our modern regulatory system, and was a steady hand amid numerous changes in leadership, providing a sounding board and sage advice to many who have led the agency, myself included,” Gottlieb posted on X, the social platform previously known as Twitter.

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Your host regrets drafting Jordan Poole in his fantasy basketball league after watching the Wizards lose yet again.

Send news and tips to Lauren Gardner ([email protected] or @Gardner_LM), David Lim ([email protected] or @davidalim) and Katherine Ellen Foley ([email protected] or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, your host Katherine talks with POLITICO Europe health care reporter Carlo Martuscelli about the U.K.’s approval of a gene-editing treatment for some rare blood diseases that may receive U.S. approval next month.

COUNTING COUGHS — FDA advisers will weigh in today on whether a Merck subsidiary’s drug candidate for chronic cough produces enough benefit to patients to warrant approval.

A briefing document released ahead of the meeting suggests that agency reviewers are torn over whether the effects of the tablet, known as gefapixant, are “clinically meaningful” to treat refractory or unexplained chronic cough, defined as a cough that lasts eight or more weeks. The condition is believed to affect about 5 percent of the U.S. population, according to a 2021 analysis of federal data.

There was a large placebo effect in both company’s trials, FDA reviewers said, and the treatment’s small reduction of one to two coughs an hour led them to question whether it yielded “a benefit that is perceptible to patients.”

Still, there’s no FDA-approved therapy for chronic cough, which can impair sleep and work productivity in patients, as well as lead to anxiety and depression.

Dr. Joerg Koglin, Merck’s senior vice president for global clinical development, said the patients who participated in the drug’s late-stage trials averaged 500 coughs a day.

Patients often must see multiple specialists to find the underlying cause of the cough before determining whether it’s chronic and unexplained, said Dr. Albert Rizzo, the American Lung Association’s chief medical officer.

The agency denied a previous attempt by Merck to win approval for gefapixant in January 2022, citing concerns about how the company validated its cough-counting data. Merck performed a recount and analyzed it for the resubmitted application.

“How much is enough for somebody who’s been suffering for a long time?” Rizzo said.

The FDA is expected to make a decision by Dec. 27, Koglin said.

CANCER DRUG CONFIRMATORY TRIALS SCRUTINIZED — The FDA’s independent advisers on oncological drugs met Thursday to discuss whether Acrotech Biopharma’s plan to conduct required confirmatory trials on two drugs for a type of lymphoma is sufficient to keep them on the market.

The FDA granted Folotyn and Beleodaq accelerated approval in 2009 and 2014, respectively. But Acrotech’s delays in submitting a protocol for a confirmatory study mean final study results may not be available until 2030, according to meeting documents from FDA scientists and the company.

To date, 12 cancer drugs that received accelerated approval and are still on the market have blown past targets for confirmatory trials, including Folotyn and Belodaq. The agency asked advisers to discuss the best ways that sponsors can meet their deadlines while conducting these confirmatory trials to avoid so-called “dangling” accelerated approvals.

But the committee did not cast a vote on a recommendation. “We don’t have a direct answer for this,” said Dr. Andy Chen, a professor of medicine at Oregon Health & Science University and acting chairperson of the meeting. “We have significant concerns over the very prolonged delay in getting these confirmatory studies underway,” he said, referring to Acrotech’s two drugs.

Other advisers, including Gita Thanarajasingam, a professor of medicine at the Mayo Clinic, noted that pulling the drugs from the market could leave some patients without any treatment options. But she also emphasized the need for confirmatory data and suggested looking for ways to encourage more patients and clinicians to participate.

EYE DROP RECALL — The Indian manufacturer of more than 20 eye drop products for several major brands issued a voluntary recall this week, the FDA said. The agency warned consumers last month not to buy or use certain over-the-counter eye drop products after FDA investigators discovered unsanitary conditions in the manufacturing facility.

UK APPROVES GENE-EDITING THERAPY — The world’s first gene-editing therapy received authorization from the U.K.’s top drug regulator Thursday. The treatment, called Casgevy, is a potential cure for severe sickle cell disease and transfusion-dependent beta thalassemia. Manufacturers Vertex Pharmaceuticals and CRISPR Therapeutics are negotiating a final price for the therapies with the U.K. government.

Casgevy is under review by the FDA, and regulators are expected to make a decision by Dec. 8. Vertex said earlier this year that it has begun talks with federal and private insurers on a possible price.

Generic drugmaker Sandoz recently hired lobbying firm S-3 Group. The lobbyists working on the account include Michaeleen Crowell, former chief of staff to Sen. Bernie Sanders (I-Vt.), and Marty Reiser, a former aide to Rep. Steve Scalise (R-La.).

Medical device procurement company Health Supply US hired Todd Strategy Group to work on issues related to supply-chain and pandemic-preparedness policies. Among the lobbyists working on the company’s behalf is Taylor Sexton, a former senior adviser to the assistant secretary for Preparedness and Response at HHS.

The FDA is finalizing an overhaul of its inspections office that is expected to be announced at the end of the month, STAT’s Sarah Owermohle reports.

House Committee on Small Business Roger Williams (R-Texas) and Rep. Dan Meuser (R-Pa.) sent a letter Thursday to the Office of Management and Budget, expressing concerns over the economic impact of the FDA’s proposed ban on menthol cigarettes.

The FDA published a discussion paper on pulse oximeter accuracy to request feedback on its approach to regulating the devices.