Califf’s long day on Capitol Hill

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

Apr 12, 2024 View in browser   By David Lim and Lauren Gardner Driving The Day FDA Commissioner Robert Califf testifies before the House Oversight and Accountability Committee on Thursday. | Anna Moneymaker/Getty Images CALIFF HOLDS COURT — FDA Commissioner Robert Califf fielded questions for more than four hours in Congress on Thursday, vacillating between testy exchanges on Covid-19 misinformation and displays of Southern charm (he’s from South Carolina, he reminded members). Here are the biggest takeaways from his testimony before the House Oversight Committee: Covid misinformation: Some Republican members blasted the FDA’s pandemic-era messaging on ivermectin, an antiparasitic drug that some doctors and conservatives touted as a Covid treatment, as overstepping into the state-regulated practice of medicine. The agency recently settled a lawsuit over its public statements advising against ivermectin use to treat the disease. But Califf held firm that ivermectin — while effective as a deworming treatment in humans — has no efficacy against Covid. “We didn’t retract everything we had to say about ivermectin,” he said, later adding: “There’s just no benefit” against Covid. Illegal vapes: Democrats and Republicans pressed Califf on the FDA’s slow pace when evaluating new tobacco product applications, of which more than two dozen have been approved. The agency has denied millions of other e-cigarette products. Califf insisted the FDA is making progress, having processed 99 percent of the applications. But members said the agency has ignored “serious” marketing proposals that could meet FDA standards. Lawmakers in both parties also took Califf to task over the proliferation of flavored vape products imported from China, which they say appeal to children. Rep. Raja Krishnamoorthi (D-Ill.) suggested the agency didn’t respond to a congressional letter asking questions about its approach to managing the issue “perhaps because you don’t have an answer — it’s because you don’t have an approach.” Avian flu: Califf expressed confidence that antiviral medicines in the national stockpile would work against the circulating strain of avian flu. “There’s nothing in it that should confer resistance to the current antivirals that we have stockpiled,” he said of the viral structure. Government agencies are holding “Zoom congresses” multiple times a day as they monitor the spread of avian flu among cattle, Califf said. One farmworker has been identified as having contracted the virus. Patents: Califf was asked about drug prices, shortages and availability that he said fall outside the agency’s authority. But questioning by Rep. Ro Khanna (D-Calif.) on patent listings yielded an interesting exchange. Khanna pressed Califf on how drug manufacturers use the Orange Book, the FDA’s patent registry for approved drugs, to list patents to shield themselves from competition for some years. Califf said the agency has “not much discretion” on what patents get added to the list and if it declined to include any, “We’d get sued.” Liberal lawmakers have urged the FDA to update guidance for drugmakers listing patents in the Orange Book; the agency has indicated it will later this year. Mifepristone: Califf declined to answer some questions about the FDA’s regulation of the abortion drug mifepristone, noting the pending Supreme Court decision regarding agency actions that expanded access to the pills. But he said that overturning the FDA’s policies would set a troubling precedent for drug development. Ethics: Khanna asked Califf to commit to not taking any consulting fees from pharma companies after he leaves government. The commissioner has already pledged not to seek work for drug or device companies he’s regulated for four years after his tenure. “I’m not looking to make money. I’m looking to contribute to the development of effective” treatments, he said, adding: “I can’t speak for the rest of my life.” IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. The fine coat of tree pollen across the District is an unwelcome reacquaintance. Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).   YOUR GUIDE TO EMPIRE STATE POLITICS: From the newsroom that doesn’t sleep, POLITICO's New York Playbook is the ultimate guide for power players navigating the intricate landscape of Empire State politics. Stay ahead of the curve with the latest and most important stories from Albany, New York City and around the state, with in-depth, original reporting to stay ahead of policy trends and political developments. Subscribe now to keep up with the daily hustle and bustle of NY politics.      Eye on the FDA The FDA is warning that certain plastic syringes made in China should not be used. | Manuel Balce Ceneta/AP CHINESE SYRINGE IMPORT ALERT — The FDA added a new import alert on Jiangsu Shenli Medical Production Co. to prevent plastic syringes made by the Chinese manufacturer from entering the U.S. The action comes months after the agency cautioned in November that it was evaluating the risk of device failure of plastic syringes made in China. The agency said this week that because of potential quality and performance issues, U.S. suppliers, consumers, providers and health care facilities should transition from using plastic syringes made by the company “unless use of these syringes is absolutely necessary until you can complete the transition.” Research Corner DRUG SHORTAGE RECORD — The number of active drug shortages has reached the highest number — 323 — since the University of Utah Drug Information Service began tracking in 2001, a report from the group said Thursday. The American Society of Health-System Pharmacists, which monitors the data as the school's partner, said common and life-saving medicines like oxytocin, standard-of-care chemotherapy and sedatives are among the products in short supply. The association applauded HHS’ recent white paper proposing ways to prevent and mitigate drug shortages but expressed concern about potential penalties for hospitals that don’t shore up medicine inventories. In the Courts MARK YOUR CALENDAR — The U.S. Court of Appeals for the Fifth Circuit on May 1 will hear oral arguments in New Orleans on PhRMA’s challenge to Medicare’s drug price negotiation program. The arguments are notable because the court tends to be friendly toward conservatives.   Easily connect with the right N.Y. State influencers and foster the right relationships to champion your policy priorities. POLITICO Pro. Inside New York. Learn more.     In Congress GOP SHUFFLES E&C ASSIGNMENTS — A handful of Republican lawmakers are moving subcommittees in the House Energy and Commerce Committee, Chair Cathy McMorris Rodgers (R-Wash.) said Thursday. Of note for health care, Rep. Troy Balderson (R-Ohio) is joining the Health Subcommittee and leaving the Communications and Technology Subcommittee. See the rest of the moves here. Tobacco BETTER REGS FOR CIG ALTERNATIVES — A pair of former Republican FDA commissioners want the FDA to use its Modified Risk Tobacco Product pathway to approve more alternative nicotine products to combustible tobacco. Scott Gottlieb and Mark McClellan took to JAMA Health Forum on Thursday to make the case that for current adult smokers, the ability to off-ramp onto a noncombustible nicotine product should be a “renewed part of the U.S. public health agenda.” “Although alternative nicotine delivery systems might reduce harm for existing smokers, they also carry the risk of initiating new nicotine users, some of whom may eventually transition to combustible tobacco,” Gottlieb and McClellan wrote, acknowledging nicotine pouch Zyn is growing in popularity on social media platforms with young audiences. “These concerns are especially heightened for children.” Pharma Worldwide AFRICAN mRNA VACCINE PLANT ON PAUSE — Vaccine maker Moderna is pulling back from its plan to build an mRNA vaccine factory in Kenya, POLITICO’s Carmen Paun reports. The pause is notable because Moderna said it would build the plant in Kenya after several African nations complained that early distribution of the Covid-19 vaccine was unequal due to rich nations hoarding supplies. The reason? Demand for the vaccines has fallen off, and Moderna has not had a buyer for its Covid vaccine in Africa since 2022. “The demand in Africa for COVID-19 vaccines has declined since the pandemic and is insufficient to support the viability of the factory planned in Kenya,” the company said in a statement. Pharma Moves Mike Bailey will join the Consumer Healthcare Products Association as senior vice president of regulatory and scientific affairs. He most recently served as head of scientific affairs for North America and the U.S. at Sanofi Consumer Healthcare. WHAT WE'RE READING Medicare could spend $3.5 billion on the Alzheimer’s disease drug Leqembi in 2025, according to estimates by CMS actuaries obtained by STAT’s Bob Herman and Rachel Cohrs Zhang. Document Drawer The White House Office of Information and Regulatory Affairs received the FDA’s clinical trial diversity action plan guidance for review. The CDC released an updated public health data strategy for 2024-2025.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

To change your alert settings, please log in at https://login.politico.com/?redirect=https%3A%2F%2Fwww.politico.com/settings This email was sent to rouf@idiot.cloudns.cc by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA Unsubscribe | Privacy Policy | Terms of Service