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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim and Lauren Gardner | With Katherine Ellen Foley. | | | — FDA’s decision to ease access to abortion pills is fueling anti-abortion groups’ efforts to derail Robert Califf’s nomination. — The Biden administration’s website to request free at-home Covid tests went live a day early. — Hundreds of millions of N95 masks from the Strategic National Stockpile will be distributed through pharmacies at no cost, President Joe Biden will announce today. It’s Wednesday. Welcome back to Prescription Pulse. 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). | | | CALIFF NOMINATION CAUGHT IN ABORTION PILL FIGHT — Anti-abortion rights groups are using FDA’s December decision to loosen restrictions on how abortion pills may be prescribed and dispensed to try to upend Califf’s bid to be agency commissioner, Alice Miranda Ollstein and Lauren report. The effort has already worked on at least two Republicans — Roger Marshall of Kansas and Tommy Tuberville of Alabama — who had indicated to POLITICO after his Dec. 14 confirmation hearing that they were inclined to support the cardiologist’s nomination . But two days later, FDA announced plans to make looser, pandemic-induced distribution rules for mifepristone permanent. Anti-abortion groups plan to keep the pressure on senators until a floor vote is scheduled, and Friday’s March for Life on the National Mall provides another avenue for them to highlight the issue. Stakes are high: Five Democrats have already voiced opposition to Califf over his record on opioids and his pharmaceutical industry ties. With just four Republicans backing him in committee, Democratic leadership has a narrow margin to navigate. Are you plugged in to how the abortion pill decision affects Califf’s odds? Drop Lauren and Alice a line. FDA, MEDICAL DEVICE MAKERS MISS DEADLINE TO SEND USER FEE DEAL TO CONGRESS — The Food and Drug Administration and the medical device industry have missed a statutory deadline to submit an agreement to Congress outlining the contours of a five-year extension of a user fee program that helps fund product evaluations, David reports. The two sides had until Jan. 15 to come up with a mutually satisfactory plan. Although the groups haven’t had a formal meeting since before Thanksgiving, negotiations are ongoing. Some of the parties’ disagreements are around the amount of funding medical device companies should provide and which programs that money should support. But there are other sticking points about the fundamental structure of the agreement, which has been in place since 2002. Industry and regulators haven’t yet agreed on whether funding from companies is guaranteed or based on FDA’s performance, nor have they agreed on how much a full-time FDA employee costs. This isn’t the first time medical device user fees have been delayed; a decade ago, they didn’t come together until two months after the initial deadline. Meanwhile, user fees for prescription drugs, generic drugs and biosimilars made their way to Congress last Wednesday. | | | | DON’T MISS CONGRESS MINUTES: Need to follow the action on Capitol Hill blow-by-blow? Check out Minutes, POLITICO’s new platform that delivers the latest exclusives, twists and much more in real time. Get it on your desktop or download the POLITICO mobile app for iOS or Android. CHECK OUT CONGRESS MINUTES HERE. | | | | | | | | FEDS LAUNCH FREE HOME TESTING WEBSITE EARLY — The Biden administration’s website where households can order four free at-home Covid-19 tests went up a day earlier than anticipated in a “beta test” on Tuesday, but some users ran into issues placing requests for tests to be delivered to apartments and other multiunit residences, POLITICO’s Ben Leonard reports. Some residents in multiunit dwellings tried to register to have tests delivered but received error messages saying tests already had been ordered for their address. An administration official said the problem was not widespread and that orders are being prioritized for people in areas facing disproportionate Covid-19 cases and deaths — the first 20 percent of test orders processed will be for people in vulnerable ZIP codes. The U.S. Postal Service said the issue stems from buildings not being registered as multiunit complexes and affected only a “small percentage of orders.” BIDEN TO ANNOUNCE N95 DISTRIBUTION EFFORT — The Biden administration is announcing today a plan to distribute 400 million free, high-quality masks through pharmacies and community health centers, David and Adam Cancryn report. The masks will be N95s sourced from the government’s Strategic National Stockpile as part of an effort to ensure Americans can access the more-protective masks during a record surge of Covid-19 cases. The administration does not have kid-sized masks to distribute, but two sources said the government is working to procure them. Biden on Wednesday is also slated to hold a press conference where he’s expected to tout the administration’s efforts to tamp down the Omicron surge and make Covid-19 tests and masks more widely available. | | | CMS COMES UNDER FIRE FOR LIMITED PROPOSED COVERAGE FOR ADUHELM — Drugmakers and patient advocacy groups are waging a campaign to cast Medicare officials as villains after the program proposed extremely limited coverage for Aduhelm, an Alzheimer’s drug from Biogen, Katherine and Megan R. Wilson report. CMS draft coverage would limit Aduhelm, the first new drug for Alzheimer’s disease in nearly two decades, to those enrolled in a CMS-authorized study. Patient groups — many of which receive donations from drug companies, including Biogen — and drug lobbyists argue that this requirement would be redundant after FDA approved the drug in June 2021. “Right now, [CMS is] just backdoor disapproving the drug,” said John Murphy, the chief policy officer at the Biotechnology Innovation Organization, an industry group. Should CMS finalize its coverage determination, not only will Aduhelm be tied up in trials: Any future drug that works like Adulhelm would also be covered only for participants in ongoing, randomized research. | | | CDRH ISSUES PLAN TO BOLSTER WOMEN-FOCUSED DEVICE RESEARCH — FDA’s Center for Devices and Radiological Health released a strategic plan Tuesday to improve medical device research and regulation for women. The framework aims to address sex- and gender-based differences in how medical conditions can affect people, considerations historically absent from biomedical research, which has largely focused on males. “Representation in research is crucial to understand how medical products, including medical devices, interact with individuals of different sexes and genders,” Terri Cornelison, director of CDRH’s Health of Women Program, said in a statement. She pointed to pacemakers as one example of a medical device that can pose different outcomes and complications for men and women. ATTORNEYS GENERAL WANT STATES TO KEEP REG POWER OVER HEARING AIDS — A group of 42 state attorneys general asked FDA to clarify what level of preemption over state-level requirements the agency intended when writing its proposal establishing an over-the-counter hearing aid market. The group argues the agency’s proposed rule contains “inadequate age verification processes mandated and deficient labeling requirements” that don’t provide “proper guardrails to protect consumers’ health” — an argument that echoes language in the Hearing Industries Association’s comments on the proposal. “The proposed rule includes broad language that could be interpreted to repeal virtually all the state-requested exemptions from preemption issued by the FDA since 1980 — even those related exclusively to non-OTC hearing aids,” the bipartisan coalition of Attorneys General wrote to FDA and HHS. “Such language could create unneeded confusion and the potential for unnecessary litigation.” | | | | BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now. | | | | | | | | VACCINE EQUITY AT RISK FROM DEMAND FOR MODIFIED COVID JABS, WARNS GAVI — Gavi, the Vaccine Alliance, said that efforts to vaccinate people against coronavirus around the world risk a setback if rich countries monopolize the supply of new vaccines designed to treat emerging viral variants, POLITICO EU’s Sarah-Taïssir Bencharif reports. Gavi delivered its billionth Covid-19 vaccine dose last weekend to Rwanda as part of COVAX and expects to ship another billion donated doses in the next four to five months. But those plans could be derailed if demand spikes for new variant-specific vaccines in wealthy regions. “I’m a little worried, frankly, if there are new variant vaccines that we might have an ‘Inequity 2.0,’” said Seth Berkley, the group’s chief executive, at the Davos Agenda, the 2022 virtual edition of the World Economic Forum on Tuesday. | | | Global drug regulators will likely work together should they decide to update Covid-19 vaccines for specific variants, STAT’s Helen Branswell reports, which ensures that manufacturers won’t make those decisions alone. Gilead Sciences identified 85,247 bottles of counterfeit versions of its HIV medications sold to patients by obscure drug suppliers and distributors, Joseph Walker and Corinne Ramey report for The Wall Street Journal. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
