FDA panel vote highlights accelerated approval concerns

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Oct 25, 2022 View in browser   By Lauren Gardner and Katherine Ellen Foley With Carmen Paun Driving the Day The FDA wants to speed up the process to remove from shelves drugs granted emergency use authorization that eventually failed to prove their effectiveness. | Manuel Balce Ceneta/AP Photo RENEWED ACCELERATED APPROVAL QUERIES, CRITICISMS  — Last week's overwhelming vote in favor of pulling preterm-birth drug Makena from the market — and the advisory committee's commentary before the 14-1 tally was taken — backed up concerns that keeping the injectable available to patients could undermine the FDA's accelerated approval process, Lauren writes. "I think it is important for us to make sure that we avoid going down the pathway that will cause regulatory chaos," said advisory committee member Mark Hudak of the University of Florida College of Medicine in Jacksonville. "I think that the accelerated approval has very clear expectations and these were not met." A look at the data: A September report from HHS' office of inspector general provides some fresh data to describe the pathway's evolution since its 1992 debut. While 278 products were approved under the program through the end of 2021, a quarter of approvals occurred in 2020 and 2021. And, as of May 2022, 13 percent of all fast-tracked drugs had been withdrawn by the drug's maker, with about half of those occurring since January 2021, the inspector general report said. Leaving Makena on the market despite the FDA's finding that it's ineffective "would upend the intention behind the accelerated approval pathway — one that pairs earlier access for promising treatments with withdrawal if the drug does not pan out," said Peter Stein, director of the FDA's Office of New Drugs. The agency's final decision isn't expected for several months, but it typically follows advisers' recommendations. IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE, where two of your newsletter writers are happy to see the Phillies make it to the World Series, while the third is a Giants fan. Send tips, feedback and sports team heckles to David Lim ( dlim@politico.com or @davidalim ), Lauren Gardner ( lgardner@politico.com or @Gardner_LM ) or Katherine Ellen Foley ( kfoley@politico.com or @katherineefoley ). TODAY ON OUR PULSE CHECK PODCAST , Daniel Payne talks with Krista Mahr about a new report from Resolve to Save Lives, which highlights the infectious diseases that didn't end in catastrophe. Listen to today's Pulse Check podcast In Congress Health insurers and payers are denying coverage for novel contraceptives by taking advantage of an outdated FDA chart of birth control methods. | Kevork Djansezian/Getty Images HOUSE OVERSIGHT: PLANS LIMIT ACCESS TO NO-COST BIRTH CONTROL — A new report by House Oversight Committee Democrats and shared exclusively with POLITICO found that some of the biggest health insurers and drug benefit managers engage in coverage restrictions and other practices that stymie access to no-cost birth-control options, contrary to the Affordable Care Act's goal. The findings confirm many practices that contraceptive-access advocates and drug manufacturers have said are widespread : Insurers and pharmacy benefit managers, known as PBMs, often impose cost-sharing requirements for dozens of products, meaning the patient has to pay a portion to help cover the drug's cost or otherwise coverage is limited. Plus, those companies often deny exception requests. "In the wake of the extreme Supreme Court decision to overturn Roe v. Wade, the ability to decide if and when to become pregnant has never been more important," Oversight Chair Carolyn Maloney (D-N.Y.) said in a statement. The panel's report identified 17 products for which all companies investigated require cost-sharing or impose coverage exclusions, including at least five that benefit patients with "distinct health care needs," such as people with conditions like high blood pressure or migraines. Four of those products aren't pills, and non-pill products are often used by low-income consumers and non-white patients, the committee said. GOP CONGRESSMEN QUESTION BIDEN ADMINISTRATION ON SMALLPOX STOCKPILE — Reps. Richard Hudson (R-N.C.) and Darrell Issa (R-Calif.) have urged HHS to disclose how many doses of smallpox vaccines — the newer Jynneos and older ACAM2000 — in the national stockpile have expired and have not been replaced. Their letter raises concerns about U.S. preparedness for a potential biological attack or an accidental release of the virus. Even before the recent monkeypox outbreak — smallpox vaccines can be used to protect people from monkeypox since the viruses are related — top U.S. health officials knew the Strategic National Stockpile didn't have enough doses of both shots.   TUNE IN TO THE PULSE CHECK PODCAST: Keep your finger on the pulse of the biggest stories in health care by listening to our daily Pulse Check podcast. POLITICO's must-listen briefing decodes healthcare policy and politics, and delivers reality checks from health professionals on the front lines. SUBSCRIBE NOW AND START LISTENING .     Tobacco TOBACCO PROGRAM REVIEW PANEL ENTERS DAY 3 OF LISTENING SESSIONS — The five-person expert panel tasked with evaluating the FDA's tobacco regulatory program will embark on its final listening sessions from industry, legal and public health experts today, Katherine reports. Today's session will focus on issues of enforcement and public education and communication; previously, the group heard input regarding regulation, guidance and the marketing application process. Lauren Silvis, a former FDA chief of staff, is leading the panel for the Reagan-Udall Foundation alongside former federal health officials with expertise in regulatory and government operations. Their formal mandate is to evaluate the Center for Tobacco Products' processes — and not specific tobacco policy decision-making — with a report due to the FDA no later than Dec. 19. Many experts in the sessions have focused on procedural issues, such as suggesting that the agency establish more general standards for tobacco products that applicants could reference when submitting new marketing authorization applications. Others pointed out the dearth of communication between FDA officials and tobacco product manufacturers after they've submitted marketing applications and the lack of guidance on designing cigarette alternatives that would maximize potential benefits to adult smokers while deterring their use by minors. Are you speaking at these sessions or submitting additional comments online? Reach out to Katherine at kfoley@politico.com . JUUL RELEASES FULL TEXT OF MARKETING DENIAL ORDERS — On Friday, Juul published the entirety of the FDA's late June marketing denial orders for all the company's products as well as the company's appeal of those orders filed a few weeks later. The company argues that the FDA's review, which found that Juul's applications didn't illustrate the full potential toxicological risks of their e-cigs, was procedurally flawed. Juul complained that, in addition to not fully reviewing all of the application materials, the FDA didn't engage with Juul via meetings or request additional information to the extent it did with other companies that received marketing authorizations. Shortly after Juul received its marketing denial orders this summer, both the company and the FDA requested a stay on the decision, putting a hold on the denial orders until the FDA re-reviews Juul's application. There's no clear timeline on when that re-review could be finished. Pharma Moves Sonja Nesbit has joined Arnold & Porter's legislative and public policy practice as a senior policy adviser focusing on health care. She previously was a managing director at FTI Consulting and is a House Ways and Means Committee and Obama HHS alum. Corey Pleasants will be Medicaid Health Plans of America's inaugural director of state affairs. He previously was director of regulatory and external affairs for Aetna Better Health of Virginia and was assistant secretary of health and human resources under former Virginia Gov. Ralph Northam. Rachel Kingery is now senior media relations manager at the American College of Obstetricians and Gynecologists. She previously was communications director for Rep. Robin Kelly (D-Ill.). Quick Hits Unilever has recalled several popular brands of dry shampoo after they were found to contain benzene, a cancer-causing chemical, Bloomberg reports. Juul is exploring a possible bailout with two of its investors, Jennifer Maloney at The Wall Street Journal reports late Monday. Document Drawer Last week, the FDA issued guidance on evaluating trials with multiple endpoints, which is applicable for new treatments that target conditions with several symptoms.   STAY AHEAD OF THE CURVE: Our Future Pulse newsletter will continue to bring you the biggest stories at the intersection of technology and healthcare, but now five times a week. Want to know what's next in health care? Sign up for our Future Pulse newsletter. If you aren't already subscribed, follow this link to start receiving Future Pulse .       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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