FDA user fee bill timeline slipping, raising layoff-notice concerns

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

Jul 01, 2022 View in browser   By David Lim and Lauren Gardner PROGRAMMING NOTE: Prescription Pulse will not publish Tuesday due to the Fourth of July holiday. We'll be back in your inboxes on Wednesday. On Tap — Congress delivering a user fee reauthorization package to President Joe Biden before August is increasingly unlikely. — The generic manufacturer of a key abortion drug plans to challenge multiple states' laws limiting access to the pills. — The FDA has asked Covid-19 vaccine makers to include the Omicron strain in any composition updates they plan for boosters in the fall. It's Friday. Welcome to Prescription Pulse. Are you House Energy and Commerce Committee Chair Frank Pallone's chief of staff Liam Fitzsimmons? We want to hear from you. Send tips and feedback 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).   DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED:  Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today.     In Congress It is unclear whether FDA Commissioner Robert Califf will issue the required reduction-in-force notices if Congress fails to miss its August goal of sending a bill to reauthorize the FDA user fee programs. | Andrew Harnik/AP Photo TICKTOCK: USER FEE REAUTHORIZATION TIMELINE SLIPPING — Congress will likely miss its self-imposed goal of sending a bill to reauthorize the FDA user fee programs to President Joe Biden's desk before August, raising the specter that reduction-in-force notices will have to be sent to thousands of agency employees, people familiar with ongoing negotiations told Prescription Pulse. An agreement to reauthorize the programs — which fund nearly half of the FDA's annual budget — is still expected to be reached before they expire at the end of the fiscal year. But difficulty pre-conferencing the significant differences between the House-passed bill and the Senate HELP Committee's package is obstructing quick passage. At issue are major provisions in the Senate deal that aim to overhaul how diagnostic tests, dietary supplements and cosmetics are regulated, which are the subject of ongoing pre-conference negotiations between the two chambers. A House Energy and Commerce Committee Republican aide said it "is becoming more challenging" to renew the user fee programs before August because of "the Senate's holdups and failure" to pass its bill out of committee before Memorial Day. "Adding major riders that do not have broad bipartisan support would slow this down even more, especially given the strong bipartisan support already received in the House on a bill that did not contain these policies," the aide said. "The Senate should follow the House's lead and get this back on track so pink slips aren't issued." Democrats are still trying to reach a deal before pink slips are sent out, an outcome that might be avoided because of the agency's large user fee carryover balances. And in July 2017, former FDA Commissioner Scott Gottlieb deferred sending out layoff notices, citing the "high degree of confidence" that the user fee programs would be reauthorized before they expired. It is unclear whether FDA Commissioner Robert Califf will again delay formally issuing the required 60-day reduction-in-force notices if Congress does not act before early August. "At this time, it would be premature to speculate on the Commissioner's actions in advance of the September 30 deadline," FDA spokesperson Lauren-Jei McCarthy wrote in an email. "The user fee programs remain an essential part of FDA's mission to protect public health and accelerate innovation, therefore making the timely reauthorization of critical importance." HOUSE APPROPRIATORS ADVANCE HHS BILL AFTER ABORTION FIGHT — The House Appropriations Committee approved $242 billion legislation Thursday on a party-line vote that would fund the Department of Health and Human Services for fiscal 2023 — but without longstanding language banning the use of federal funds to cover abortions. Debate over the so-called Hyde amendment dominated the first two hours of the markup, with Republicans arguing that the provision would eventually need to be added to the bill to win enough Senate votes for HHS funding to be appropriated. The committee adopted an amendment to the bill report urging HHS to ensure abortion medication is "accessible, affordable, covered and convenient for patients, including through access to telehealth." The report already contained language calling on the department to bolster access to contraceptives. In the Courts Makers of mifepristone are suing states that restrict the abortion pill's access. | Allen G. Breed/AP Photo GENERIC ABORTION PILL MAKER PLAN MORE LAWSUITS — GenBioPro, the generic manufacturer of mifepristone, plans to take to court more states that have instituted laws restricting access to abortion drugs, Lauren scoops. Ken Parsigian, one of the company's attorneys, wouldn't specify which states they're eyeing, but it's safe to say they have their pick of more than a dozen states where abortion is already illegal or soon will be. GenBioPro has already sued Mississippi over its law effectively banning telehealth abortions by making pregnant patients visit doctors in person before and after receiving the pills, despite the FDA ending its own requirement that the pill be personally distributed in 2021. States with existing obstacles to telehealth abortions coupled with those moving to ban the practice before 10 weeks of pregnancy, which is up to when abortion pills are approved for use, give the company a range of venues to test a legal strategy that hinges on the notion that FDA approval of a drug trumps any state effort to restrict it. Parsigian pointed to Biden administration officials' statements calling out abortion pill access as aligned with his client's argument. "If [Attorney General Merrick Garland had] mentioned our suit by name, it would have fit right into what he said," Parsigian said. "We are doing what he said they want to do." Waiting on the administration: HHS launched a website in the wake of the Supreme Court decision overturning Roe v. Wade, but the effort might not be enough to stem progressive criticism that the Biden administration did little to prepare for the precedent's fall — and has yet to detail how exactly it plans to improve access to abortion pills, Lauren and POLITICO's Sarah Owermohle report. Related reading: A new study shows Google searches for information about abortion medications soared after POLITICO published the Supreme Court's draft opinion overturning Roe v. Wade on May 2, POLITICO's Ruth Reader writes. EPA SCOTUS OPINION RAISES BROADER AGENCY AUTHORITY QUESTIONS — A 6-3 Supreme Court ruling on Thursday that the Environmental Protection Agency does not have broad authority to curb pollution from power plants is raising concerns that other aggressive regulatory efforts by agencies could soon face increased legal scrutiny, POLITICO's Alex Guillén reports.   INTRODUCING POWER SWITCH: The energy landscape is profoundly transforming. Power Switch is a daily newsletter that unlocks the most important stories driving the energy sector and the political forces shaping critical decisions about your energy future, from production to storage, distribution to consumption. Don't miss out on Power Switch, your guide to the politics of energy transformation in America and around the world. SUBSCRIBE TODAY.     Coronavirus FDA ASKS VACCINE MAKERS FOR OMICRON BOOSTERS — Covid-19 vaccine manufacturers that want to update their formulations for the fall should develop bivalent boosters containing both the current shot composition and a component targeting the Omicron BA.4 and BA.5 spike proteins, the FDA said Thursday. The agency's ask came two days after its independent vaccine advisers voted 19-2 to recommend that the vaccines be updated to account for the Omicron variant ahead of a fall booster campaign. The Biden administration announced Wednesday it will buy 105 million shots — a combination of adult and pediatric doses — of Pfizer's Omicron-targeting vaccines for $3.2 billion. Eye on the FDA FDA SETS ADCOM TO DISCUSS DOWNCLASSING MELANOMA DETECTION AID — The FDA on Wednesday proposed to reclassify class III optical diagnostic devices for melanoma detection and electrical impedance spectrometers as "computer-aided devices which provide adjunctive diagnostic information about lesions suspicious for melanoma." If approved, they would be regulated as class II medical devices with special controls. The agency's General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee is scheduled to discuss the potential reclassification — which would allow firms to submit a 510(k) application instead of a premarket approval application for the device type — on July 28 and 29. WARREN, GRASSLEY: HEARING AID MAKERS ASTROTURFING OTC REG — Top hearing aid manufacturers are mounting an astroturf campaign to convince the FDA to enact over-the-counter hearing aid regulations that would allow lower device output levels than the agency initially proposed, according to a new congressional investigation conducted by Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa). The lawmakers sent the findings in letter to Califf. "Although couched in concerns about patient safety, the changes sought by these dominant manufacturers and their representatives would actually have the effect of making OTC hearing products less effective, protecting manufacturers' existing market share and locking in their competitive advantage," Warren and Grassley's investigation states. The Biden administration signaled in its recently released Unified Agenda that the FDA plans to issue a final rule to establish a regulatory pathway for over-the-counter hearing aids this month. Pharma Moves The FDA has hired Namandjé N. Bumpus as its new chief scientist and Hilary D. Marston as its new chief medical officer. Quick Hits The FDA has ordered Sanofi to stop treating some patients in Phase 3 trials with an experimental multiple sclerosis drug amid cases of drug-induced liver injury, BioPharma Dive reports. Newly released documents reveal consulting firm McKinsey & Company advised Opana manufacturer Endo and other opioid manufacturers, including Mallinckrodt, The New York Times' Chris Hamby and Michael Forsythe report. Document Drawer The FDA issued a warning Thursday that the cancer drug Copiktra may be associated with an increased risk of death and serious side effects compared to another medicine to treat leukemia and lymphoma. Sens. John Hickenlooper (D-Colo.) and Tina Smith (D-Minn.) sent a letter to Califf on Thursday asking what steps the FDA is taking to address contrast media shortages.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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