A busy year ahead for the FDA

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

Dec 22, 2023 View in browser   By David Lim and Lauren Gardner Programming Note: We’ll be off next week for the holidays but back to our normal schedule on Wednesday, Jan. 3. Driving the day The Food and Drug Administration has several policies slated to be released in 2024. | Sarah Silbiger/Getty Images 2024 LOOK AHEAD — Washington is ending 2023 without a so-called Christmas tree bill in Congress, leaving plenty — including FDA appropriations and a potential health care legislative package — for lawmakers to address when they return in the New Year. The FDA also has its hands full. Here’s what we’re keeping our eye on in 2024: Changing of the guard: The FDA is prepping for the departure of Principal Deputy Commissioner Janet Woodcock and her almost 40 years of experience — a near-seismic event at an agency tasked with regulating 20 percent of the U.S. economy. FDA Chief Scientist Namandjé Bumpus is slated to succeed the longtime regulator as Califf’s No. 2. The downstream effects of Woodcock’s retirement on the agency’s regulatory stance toward drug oversight and day-to-day operations will likely ripple for many months if not years to come. Inspections get an overhaul: The agency will reorganize its inspection workforce with the rebranding of the Office of Regulatory Affairs as the Office of Inspections and Investigations. The goal? Strengthening the agency’s field-based oversight program. The revamp comes partly in response to the agency’s handling of the Abbott infant formula crisis and increased scrutiny by Republican lawmakers of the FDA’s foreign drug inspection program. Where are the tobacco regs: The White House’s regulatory clearinghouse continued to take meetings on pending final rules to ban menthol cigarettes and flavored cigars. The Biden administration’s latest Unified Agenda is targeting a March release for those regs and an April release for a proposal to set a maximum nicotine level in cigarettes and some other tobacco products. Changes in the cold/flu aisle: Agency advisers unanimously agreed in September that phenylephrine, a common ingredient in over-the-counter cold medicines, is ineffective at relieving stuffy noses when taken orally. That vote put the FDA on notice to decide whether to pull popular products off store shelves. It’s unclear when the FDA might act and the regulatory process to remove the ingredient from the market could take months or longer. In the meantime, consumers are pursuing class-action lawsuits against the drugmakers behind some of the products, and the Wall Street Journal reported that CVS is discontinuing sales of cold medicines containing phenylephrine as the sole active ingredient. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We hope you have a safe and restful end to 2023. Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim). TODAY ON OUR PULSE CHECK PODCAST, host Chelsea Cirruzzo talks with POLITICO health care reporter Daniel Payne about the ways artificial intelligence is already used across the medical landscape and how regulators are responding. Listen to today’s Pulse Check podcast Eye on the FDA GUIDANCE CHRISTMAS TREE — The FDA is clearing the regulatory deck ahead of the New Year, issuing a slew of final guidance documents in recent days on digital health technologies, real-world data from trial registries, master protocols for drug and biological development, updated recommendations on Covid-19 monoclonal antibody development and more. COMMON (FINAL) RULE — A longtime priority of FDA Commissioner Robert Califf — improving clinical trials — got a boost this week with the release of a final rule updating rules of the road aimed at protecting people who participate in clinical research. “We anticipate this new rule will enable minimal risk research that would not be practicable to conduct otherwise,” Califf wrote in a blog post. At the Agencies The Federal Trade Commission stepped in to intervene in pharmaceutical industry deals in 2023. | Pool photograph by Graeme Jennings GAO: BETTER DEVICE CYBER COORDINATION NEEDED — The FDA and the Cybersecurity and Infrastructure Security Agency should update how they collaborate, the Government Accountability Office wrote this week to bipartisan leaders of the Senate HELP and the House Energy and Commerce committees. “FDA developed a documented coordination agreement with CISA to support cybersecurity of medical devices; however, the agreement is outdated and does not reflect organizational and procedural changes that have occurred over the last 5 years,” the GAO report states. HHS Assistant Secretary for Legislation Melanie Anne Egorin said the federal health department will begin working with CISA to update the information-sharing agreement. A MAZE FOR PHARMA ACQUISITIONS? — Two Federal Trade Commission members took the unusual step of issuing a lengthy statement touting the antitrust body’s successful intervention against Sanofi’s now-abandoned effort to exclusively license Maze Therapeutics’ Pompe disease drug that successfully finished Phase I trials. The intervention caught the attention of many in the pharmaceutical industry, who worry the step will chill drug development because large drugmakers often partner or acquire smaller drug developers to commercialize a drug. “The complaint recognized that early-stage drugs could pose a competitive threat to an existing monopoly drug, even if the ultimate success of the early-stage drugs is not guaranteed,” FTC Chair Lina Khan and Commissioner Rebecca Kelly Slaughter said. “The complaint also broke new ground by charging that an acquisition of a product in the pipeline with no sales can still constitute illegal monopolization.” Craig Garthwaite, a health economist at Northwestern University's Kellogg School of Management, said it is important for the FTC to clarify whether its primary concern was that Sanofi would kill development of the potentially competitive drug or in effect create a monopoly in the rare disease area. “It’s not clear that multiple firms have the ability to support infrastructure to develop a set of treatments in the rare disease area,” Garthwaite said. “It will be interesting with this particular example. Does it get the assistance of another firm to bring it to market or does it never really get to market because Maze is unable to attract capital to bring it to the market itself?” WHAT WE'RE READING AdvaMed CEO Scott Whitaker sat down with POLITICO’s Megan R. Wilson to discuss the medtech lobby’s priorities in 2024. Former FDA Principal Deputy Commissioner Amy Abernethy is departing Verily, STAT’s Matthew Herper reports. Pharma Worldwide WHO ENDORSES SECOND MALARIA VACCINE — The World Health Organization prequalified the R21/Matrix-M malaria vaccine, making it easier to procure by international organizations, which could in turn provide wider access to it, POLITICO’s Carmen Paun reports. Document Drawer The FDA will hold a webcast on Jan. 10 at 2 p.m. to discuss the current medical device sterilization landscape — including ethylene oxide. HHS is asking for feedback on the impact that potential concepts being negotiated for the WHO’s Pandemic Preparedness Agreement may have on the rapid creation and equitable distribution of vaccines, diagnostics and treatments.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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