Woodcock to depart FDA after nearly four-decade career

Presented by AHIP: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Nov 17, 2023 View in browser   By David Lim, Katherine Ellen Foley and Lauren Gardner Presented by With Megan R. Wilson Principal Deputy FDA Commissioner Janet Woodcock will retire from her post early next year. | Stefani Reynolds/Getty Images 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 (lgardner@politico.com or @Gardner_LM), David Lim (dlim@politico.com or @davidalim) and Katherine Ellen Foley (kfoley@politico.com 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. Listen to today’s Pulse Check podcast A message from AHIP: Big Pharma alone controls prescription drug prices, continuing to raise prices and making health care more expensive. Now, they are trying to run out the clock on American patients by shifting attention from their egregious practices – like abusing the patent system – to avoid accountability, undermine patients’ bargaining power and keep prices high. It’s time to stop Big Pharma from running out the clock on real solutions that will hold them accountable.   Eye on the FDA A Merck subsidiary's drug to treat chronic cough is set to be reviewed by FDA advisers. | Matt Rourke/AP 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.   GET A BACKSTAGE PASS TO COP28 WITH GLOBAL PLAYBOOK: Get insider access to the conference that sets the tone of the global climate agenda with POLITICO's Global Playbook newsletter. Authored by Suzanne Lynch, Global Playbook delivers exclusive, daily insights and comprehensive coverage that will keep you informed about the most crucial climate summit of the year. Dive deep into the critical discussions and developments at COP28 from Nov. 30 to Dec. 12. SUBSCRIBE NOW.     Pharma Worldwide 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.   A message from AHIP:   Pharma Moves 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.   A NEW POLITICO PODCAST: POLITICO Tech is an authoritative insider briefing on the politics and policy of technology. From crypto and the metaverse to cybersecurity and AI, we explore the who, what and how of policy shaping future industries. We’re kicking off with a series exploring darknet marketplaces, the virtual platforms that enable actors from all corners of the online world to traffic illicit goods. As malware and cybercrime attacks become increasingly frequent, regulators and law enforcement agencies work different angles to shut these platforms down, but new, often more unassailable marketplaces pop up. SUBSCRIBE AND START LISTENING TODAY.     WHAT WE'RE READING 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. Document Drawer 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. A message from AHIP: Big Pharma’s latest play? Spending millions of dollars on advertising in an attempt to shift the blame to others, avoid accountability, undermine the bargaining power health insurance providers deliver and keep prescription drug prices – and their profits – high. Congress has the opportunity for a slam dunk by lowering drug prices for patients by stopping pharmaceutical companies’ blame game, patent abuse and price hikes. When drug prices go down, Americans pay less. That’s why health insurance providers negotiate with drug companies for lower out-of-pocket costs and premiums for millions of patients. Congress: Call a foul on Big Pharma and pass solutions that will deliver lower prescription drug prices.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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