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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Lauren Gardner and David Lim | With Katherine Ellen Foley and Darius Tahir | | | — Covid-19 antiviral pills were supposed to be game changers. But bureaucratic and logistical hurdles are combining to complicate drug access. — FDA is extending its pause on non critical domestic inspections because of the impact of the Omicron variant. — House Oversight Committee Republicans are ratcheting up the pressure on FDA to explain its emergency use authorization decision-making process. It’s Friday. Welcome back to Prescription Pulse. We salute the sleuthing and social media skills of the New York women who collectively brought West Elm Man to our attention. 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). | | | COVID DRUG ACCESS ELUSIVE AMID SUPPLY, LOGISTICAL ‘CHAOS’ — In an earlier stage of the pandemic, antiviral drugs for Covid were envisioned as Tamiflu-esque: They’d be easy to pick up at a pharmacy and take at home, less costly than intravenous infusions of monoclonal antibodies and, more often than not, prevent consumers from developing severe bouts of the disease. That’s far from the case right now, Lauren reports, and not just because of the supply crunch. A confluence of regulatory, testing and logistical issues is complicating the pills’ rollout. The emergency use authorizations for Merck’s molnupiravir and Pfizer’s Paxlovid limit prescribing authority to doctors and certain physician assistants and nurses, cutting out pharmacists who already have PREP Act protections that allow them to administer Covid vaccines. Health officials and pharmacists say that raises the prospect of forcing symptomatic patients to make multiple stops for tests, prescriptions and the pills themselves, and all within the five-day window in which they must start the regimens. The drugs themselves have their limitations: Molnupiravir is much less effective than Paxlovid and might potentially cause birth defects, while Paxlovid interacts with dozens of drugs commonly prescribed to Americans. The pharmacists’ frustration is compounded by low reimbursement rates of sometimes $1 or less they say they’re getting for advising patients about the antivirals. “How many pharmacies are going to continue to even partner with the state health departments?” said Rebecca Snead, executive vice president and CEO of the National Alliance of State Pharmacy Associations. VETS’ HOMES AHEAD ON BOOSTER PACE — Nursing homes for elderly veterans are ahead of their civilian counterparts’ pace in booster administration, according to data shared with POLITICO from the VA. POLITICO’s Darius Tahir reports that 71 percent of patients in both Community Living Centers and State Veterans Homes — nursing homes and long-term care centers run by the federal VA and state agencies, respectively — have gotten their booster shots, the agency says. (The 71 percent figure for state veterans homes applies to patients eligible to get boosted; the figure for the centers is for the overall population.) The figures suggest the booster pace is running ahead of the civilian pace. Nearly 65 percent of residents of nursing homes have gotten boosted, according to the CDC. For watchers of state veterans homes, it’s a reversal of previous trends: The homes had an elevated death rate and were marred by political scandal. STUDY: COVID VACCINES DON’T AFFECT CONCEPTION CHANCES — An NIH-funded study of more than 2,000 couples has found that Covid vaccination doesn’t appear to hinder fertility. However, Covid infection may cause a temporary decline in fertility for some males if they test positive within 60 days of a given cycle. | | | | JOIN NEXT FRIDAY TO HEAR FROM GOVERNORS ACROSS AMERICA : As we head into the third year of the pandemic, state governors are taking varying approaches to public health measures including vaccine and mask mandates. "The Fifty: America's Governors" is a series of live conversations featuring various governors on the unique challenges they face as they take the lead and command the national spotlight in historic ways. Learn what is working and what is not from the governors on the front lines, REGISTER HERE. | | | | | | | | GOP PRESSURES FDA OVER COVID DRUGS, BOOSTERS — House Oversight Committee Republicans are demanding details on the FDA’s emergency use authorization process and raising questions about why the agency hasn’t sped more Covid-19 treatments to market. In a letter to acting FDA Commissioner Janet Woodcock, the lawmakers requested information on how many EUA applications the FDA has received for such treatments, how many were rejected and the expected approval dates for any still pending. But the GOP letter previews a line of attack the party may pursue if it wins back the majority. The committee’s top Republican, Rep. James Comer (R-Ky.), also sent Woodcock a separate letter Wednesday asking about the FDA’s decision not to convene its outside advisory panel before making some decisions on vaccines and whether those moves were politically influenced. PHARMA COMPANIES PUSH FOR DRUG SUPPLY CHAIN BILL — Two dozen companies and two coalitions sent a letter Thursday to the Democratic and Republican leaders of the House and Senate health and tax committees, urging them to advance legislation to overhaul the domestic supply chain for drugs and medical equipment. The bills, H.R. 3927 (117) and S. 2082 (117), would create a 30 percent tax credit for medical manufacturers who set up shop in Opportunity Zones and would revamp FDA’s inspection process for facilities making scarce drugs. “If the U.S. is to continue to lead the world in healthcare innovation, it is critical that Congress take concrete action to streamline our regulatory system, encourage the adoption of new manufacturing technologies, and reshore our domestic supply chain for branded drugs, generics and biosimilars,” and other medical products, wrote the group, which includes brand-name and generic companies like Pfizer, Teva Pharmaceuticals and Coherus BioSciences. | | | FDA EXTENDS PAUSE ON NON-CRITICAL DOMESTIC INSPECTIONS — FDA on Tuesday extended its pause on noncritical domestic inspections through Feb. 4 because of the ongoing spread of the Omicron variant. “The agency will proceed with previously planned foreign surveillance inspections that have received country clearance and are within the CDC’s Level 1 or Level 2 COVID-19 travel recommendation; otherwise, the inspection will be rescheduled,” FDA spokesperson Michael Felberbaum said. “The FDA’s goal is to return to a regular cadence for foreign surveillance inspections in April.” FDA TOUTS NEW REMS DASHBOARD — FDA on Thursday announced it launched a new public dashboard that lists drugs with an approved Risk Evaluation and Mitigation Strategy. “This new dashboard includes visualizations and charts for total and active REMS programs, elements to assure safe use, REMS modifications, revisions and released REMS programs that are no longer in effect,” the agency said. | | | JUDGE ASKS FOR SECOND EXTENSION FOR DECISION IN FTC V. ALTRIA-JUUL CASE — The Federal Trade Commission’s Chief Administrative Law Judge D. Michael Chappell asked for a second extension Wednesday for his decision in the challenge of Altria’s 35 percent stake in Juul Labs. Chappell was initially scheduled to make a decision today, but FTC granted the extension until Feb. 17. | | | | 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. | | | | | | | | Eric Bastings has stepped down from his role as deputy director of FDA’s Office of Neuroscience and has taken a role as the vice president of development strategy at Ionis Pharmaceuticals. Frank Clyburn, the executive vice president and president of human health at Merck, will step down on Feb. 1. The company has appointed David Weinstock vice president for Discovery Oncology. Rachel Sher has joined Manatt’s Washington-based health group to counsel clients on FDA regulatory issues. She most recently served as vice president for policy and regulatory affairs at the National Organization for Rare Diseases, and she spent 10 years as House Energy and Commerce Democrats’ FDA counsel and nearly three years at FDA. Hal Barron is departing his role as GlaxoSmithKline’s chief science officer in August 2022 to become CEO and board co-chair of Altos Labs. He will remain on GSK’s board as a non-executive director for an “initial period of three years.” | | | TUESDAY: Johnson & Johnson holds its earnings call at 8:30 a.m. EST. | | | NEW YORK SENATE CONFIRMS BASSETT AS HEALTH COMMISSIONER — New York state lawmakers approved Gov. Kathy Hochul’s pick to lead the Department of Health on a 43-20 vote along party lines following a brief floor debate over Bassett’s policy agenda, POLITICO New York’s Shannon Young reports. | | | EU COUNTRIES PREPARE SHIFT TO ‘PERSON-BASED’ TRAVEL RULES — EU countries are closing in on new travel restrictions that focus on a traveler’s individual health risk instead of their country of departure, POLITICO EU’s Hanne Cokelaere and Carlo Martuscelli report. Passengers within the bloc with a Covid certificate — which shows whether a person has been vaccinated or recently infected — wouldn’t face additional testing or quarantine, three EU diplomats said Thursday. Member countries may adopt these measures at a General Affairs Council Tuesday. | | | Biden FDA commissioner nominee Robert Califf said it is a failure there is often not quick confirmatory evidence produced after a company receives an accelerated approval for a drug during remarks at the CERSI Summit, Endpoints News’ Zachary Brennan reports. An analysis by the Kaiser Family Foundation found about half of reviewed insurers are offering reimbursement for only at-home tests, rather than a direct coverage option. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. Orphan drug “exclusivity cliff” approaches — A significant number of drug products approved by the FDA for rare diseases are set to lose their market exclusivity — the period of time during which the FDA will not approve a generic of the same product for the same condition — starting in 2024, according to an analysis by POLITICO’s AgencyIQ of the FDA’s Orphan Drug Designation database. Between 2024 and 2028, 366 rare disease drugs will lose exclusivity protections. The annual number of drugs losing exclusivity is set to greatly exceed historical averages, which until 2020 had never exceeded 30 per year. In comparison, 49 products are expected to lose exclusivity protections in 2022, and 88 in 2025. While some of the products losing marketing exclusivities are likely still protected by patent exclusivity periods, further delaying market competition, those without could face generic competition immediately thereafter. FDA guidance on racial and ethnic diversity in clinical trials under review — The FDA this week sent a much-anticipated draft guidance document on the topic of enrollment of diverse racial and ethnic populations in clinical trials to the White House’s Office of Information and Regulatory Affairs for review. The FDA previously issued guidance on “Enhancing the Diversity of Clinical Trial Populations ,” which was finalized in 2020. That guidance outlines (and recommends) approaches that may increase the ability for historically underrepresented populations to participate in clinical trials. However, while it recommended that “sponsors include a plan for inclusion of clinically relevant populations no later than the end of the Phase 2 meeting,” it stopped short of recommending that sponsors specifically develop proactive plans for ensuring that trial populations are racially diverse, or that they bolster health equity. Based on the title of the draft guidance currently under review, it appears these types of plans will be the focus of the new document. | | | FDA on Thursday classified retinal diagnostic software as a class II medical device with special controls. FDA on Thursday proposed to classify hHuman leukocyte antigen, human platelet antigen and human neutrophil antigen devices as Class II devices with special controls. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
