FDA allows retail pharmacies to dispense abortion pills

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Jan 04, 2023 View in browser   By Katherine Ellen Foley and Lauren Gardner Driving the Day The FDA says that brick-and-mortar pharmacies can dispense the medication abortion drug mifepristone if they choose to. | Victor R. Caivano/AP Photo FDA MOVE WIDENS ACCESS TO ABORTION PILLS — The FDA late Tuesday updated its drug-safety program rule for mifepristone, one of the drugs used in medication abortion, to allow it to be dispensed at brick-and-mortar pharmacies. The move expands access to the drug amid a wave of state efforts to impose restrictions following the fall of Roe v. Wade — and likely sets up more legal fights from anti-abortion groups and states. Chain and independent pharmacies will be permitted to stock and dispense mifepristone to pregnant people with a prescription from a certified prescriber. But it's unclear how many pharmacies will agree to do so since they'd also have to follow a special certification process. Until now, pregnant people could receive the pill either directly from their doctor or via telemedicine and sent by mail, depending on their state's laws. Still, the new rule's reach will be felt in states that already allow the pill's use, though patients in states with abortion restrictions on the books could travel to pick the drug up from an out-of-state pharmacy. IT'S WEDNESDAY. WELCOME TO PRESCRIPTION PULSE. We're still reeling from the thought of not seeing The Thing parked around the Capitol on a regular basis. Send tips, feedback and Capricorn energy 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, Katherine talks with POLITICO's Alice Miranda Ollstein about the actions anti-abortion groups want the new GOP House majority in Congress to take. Listen to today's Pulse Check podcast Coronavirus Monoclonal antibodies have been successfully used to treat Covid by binding with the virus' spike proteins in the past, but they're not as effective against new variants. | Centers for Disease Control and Prevention LACK OF EFFECTIVE MONOCLONAL ANTIBODIES WORRIES IMMUNOCOMPROMISED — Specialized Covid-19 treatments, once heralded as game-changers for those at risk of getting severely ill from the virus, are not effective against Omicron and other widely circulating variants, leaving millions of people who have weakened immune systems vulnerable, Lauren reports. A few companies made those treatments, called monoclonal antibodies, which work by blocking the virus' entry into cells by binding with a portion of the virus' spike protein. But the existing antibodies can't bind with newer variations of the virus as it mutates. In 2022, the FDA pulled authorizations for four Covid monoclonal antibody treatments, citing reduced efficacy. While antiviral pills, like Pfizer's Paxlovid and Merck's Lagevrio, are still an option for some patients, they don't work for everyone. Paxlovid can't be taken with many widely prescribed drugs, while Lagevrio has shown lower efficacy compared to its competitor and to remdesivir, an IV-administered antiviral that requires three days of treatment. And the pipeline for more monoclonals is pretty empty: The federal government funding that drove drug development in the pandemic's early days has dried up, and lawmakers have rebuffed the Biden administration's pleas for more. Without that, drugmakers have little incentive to develop new antibody treatments that could be more effective. The omnibus spending bill lawmakers passed before Christmas left out the administration's $9 billion request for more money to fight the pandemic, meaning fewer dollars are available to address ongoing and emerging Covid needs. Eye on the FDA HOUSE DEMS RAISE ISSUES WITH FDA REVIEW PROCESS FOR ADUHELM — A joint report released last week by House Oversight and Energy and Commerce committees' Democratic staff found that the FDA's collaboration with Biogen, the maker of a controversial Alzheimer's drug, was "atypical" and skirted the agency's protocols for documenting interactions with drug companies, Lauren reports. The committees' report found that the agency inappropriately worked with Biogen to draft briefing documents for presentation to an advisory committee meeting and failed to adequately track meetings, phone calls and emails. The report also found that the FDA shifted Aduhelm's review from a traditional to accelerated approval pathway late in the process after agency scientists questioned whether the drug would benefit patients. In a statement, the FDA cited an internal review that found the actions were appropriate and said the agency has already started implementing changes consistent with the House committees' recommendations. FDA DEVICE CYBER CHIEF APPLAUDS NEW POWERS IN OMNI — The head of the FDA's office overseeing medical device cybersecurity called new powers included in the omnibus spending bill a "huge milestone" for health care, our Morning Cyber colleagues report. The $1.7 trillion spending package grants the FDA the right to stipulate which cybersecurity requirements manufacturers must meet before bringing internet-connected devices to market and the ability to enforce stricter security maintenance for approved products. The FDA has long recommended that makers of life-saving devices, such as insulin pumps and ventilators, provide better product-security protections, such as delineating a clear process for disclosing security bugs and producing a software ingredients list. But because that guidance was voluntary, only a "fraction" of medical device manufacturers adopted the practices, Suzanne Schwartz, director of the office of strategic partnerships and technology innovation at the FDA's Center for Devices and Radiological Health, said. Public Health THE FIRST OTC NALOXONE MAY NOT HELP THOSE AT HIGHEST OVERDOSE RISK — The Biden administration's latest effort to make some forms of opioid overdose reversal drugs available without a prescription likely won't benefit those at the highest risk of overdosing, Katherine reports. Last year, the FDA said it would consider approving some forms of naloxone as an over-the-counter drug if manufacturers submitted certain data. The agency identified two versions of naloxone as appropriate for OTC use: Either up to 4 milligrams of a naloxone nasal spray or 2 milligrams of naloxone administered through an autoinjector. The agency singled out those two forms of naloxone because they are the easiest for the public to use. Public health experts, however, caution that while those OTC naloxone products would help at the margins, they won't address funding challenges for harm-reduction programs, which are the primary naloxone providers for those who smoke or inject opioids and most likely to overdose. The programs distribute free injectable vials of naloxone that cost as little as $6 a dose. But the programs are already stretched far beyond what's needed: There are just over 400 needle-exchange programs across the country, according to the Kaiser Family Foundation; some states have none. "What we really need is for the FDA to be bold and lead the process themselves, making [syringe-injectable] naloxone available OTC everywhere," said Sarah Evans, the division director of drug policy at Open Society Foundations, a political network founded by George Soros. Pharma Moves Will McAuliffe will serve as Democratic chief counsel for the House Energy and Commerce Subcommittee on Oversight and Investigations. He joined the panel in 2021 as counsel and worked on the Democrats' Aduhelm approval investigation and inquiries into insulin prices. Molly Block rejoins the personal office of Sen. Bill Cassidy (R-La.) this week after serving as communications director for Sen. Kevin Cramer (R-N.D.). Anali Alegria has left the Senate HELP majority's press shop. Mark Battaglini will serve as the first chief strategy officer for the Alliance for Regenerative Medicine, an industry trade group. Quick Hits The Drug Enforcement Administration wrote a letter to the makers of ADHD treatments, citing concerns about "aggressive marketing practices" among telehealth providers, The Wall Street Journal's Rolfe Winkler reports. Health care lobbyists brace for longtime maverick Sen. Bernie Sanders as the leader of the Senate HELP committee, POLITICO's Megan R. Wilson reports. Parents decry the lack of FDA action on infant formula safety as the agency continues to respond to internal and external recommendations to improve its food safety program, Helena Bottemiller Evich writes for POLITICO.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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