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Presented by UnitedHealth Group: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Lauren Gardner , David Lim and Katherine Ellen Foley | | | | | | | 
The Advisory Committee on Immunization Practices vote does not mean the Covid vaccines are mandated for children. | Jessica McGowan/Getty Images | CDC ADVISERS RECOMMEND ADDING COVID SHOTS TO VACCINE SCHEDULES — The CDC’s independent vaccine advisers voted unanimously Thursday to recommend the agency add Covid-19 vaccines to the childhood, adolescent and adult immunization schedules for 2023 . The recommendation applies to most Covid vaccines administered in the U.S., regardless of whether they’re authorized for emergency use (so shots for young children and boosters) or fully approved by the FDA. Not a mandate: The vote caused a stir on social media after Fox News commentator Tucker Carlson incorrectly claimed earlier this week that the vote would trigger mandates for students. While states often consult the schedules to make decisions about which vaccines to mandate for school entry, it’s up to them — or local jurisdictions, depending on the state — to decide which to require. Many don’t require flu and HPV vaccines, which have been on the childhood schedule for years, for students. And 21 states have banned Covid vaccine mandates for students. Non-federal levels of government “are the arbiters of what vaccines are required, if any, for school entry,” said advisory committee member Nirav Shah, who heads Maine’s Center for Disease Control and Prevention. “This discussion does not change that.” Expanding access: The committee also voted Wednesday to add Covid shots to the federal Vaccines for Children program, David writes. That means children who may not otherwise get vaccinated because their families can’t afford it will have access to those immunizations at no cost once the federal government stops covering the vaccines for everyone, which could begin as soon as January. It’s Friday . Welcome to Prescription Pulse, where your hosts’ are already enjoying the new Taylor Swift and Carly Rae Jepsen albums. Send tips, feedback and your favorite tracks 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 , Ben Leonard talks with Alice Miranda Ollstein about the upcoming decisions in Congress on telehealth funding. Plus, a dispatch from Pennsylvania, where a statehouse race is testing whether the GOP’s last abortion-rights supporters can survive.
| | | | | A message from UnitedHealth Group: Starting in 2023, we’re eliminating out-of-pocket costs for UnitedHealthcare fully insured group members on five life-saving medications, including insulin and epinephrine. Learn how we’re working to make prescription drugs more affordable for the patients who rely on them most. | | | | | | GOP QUESTIONS WHY U.S. CONTRACTED RAPID TESTS MADE IN CHINA — Top Republicans on the House Committee on Oversight and Reform on Thursday asked HHS to provide documents and communications related to its decision to acquire rapid Covid-19 tests from iHealth — which sells tests made in China — instead of American-made tests. “We request documents and information related to the use of taxpayer funds to procure testing materials in order to understand why the Administration chose Chinese manufacturers to the detriment of domestic testing sources,” ranking member James Comer (R-Ky.) and other lawmakers wrote . The Biden administration acquired hundreds of millions of rapid over-the-counter tests from iHealth to help respond to the Omicron surge — many of which were distributed through the U.S. Postal Service. U.S.-based Abbott and Swiss multinational Roche Diagnostics also were contracted to supply significant numbers of tests for the popular government program. “There was not enough U.S. capacity for demand,” White House spokesperson Kevin Munoz said. “Would they prefer we just didn’t get tests?”
| | | ALTRIA, PMI REACH NEW AGREEMENT ON ONLY U.S. HEATED TOBACCO DEVICE — Philip Morris International and Altria have ended their licensing agreement for IQOS, one of the only tobacco products cleared by the FDA as being less harmful than conventional cigarettes. The product is similar to a cigarette but heats rather than burns the tobacco. The companies forged the initial agreement in 2013, when PMI gave Philip Morris USA, an Altria subsidiary, the exclusive right to sell IQOS for five years after its FDA authorization in 2019. PMI, IQOS’ original maker, has now agreed to pay Altria $2.7 billion to market and sell the product starting in May 2024. IQOS is unavailable in the U.S. after the International Trade Commission banned its importation over a PMI patent dispute with British American Tobacco last year. PMI is gearing up U.S. manufacturing capabilities with plans to get around this dispute and expects the production of IQOS to be up and running by mid-2023, but it will need to submit a supplemental application to the FDA to market the product based on the production changes. Altria said that it will assess options to promote and sell the product before May 2024. FDA, DOJ ASK COURTS FOR PERMANENT INJUNCTIONS AGAINST 6 E-CIG MAKERS — The Biden administration on Tuesday launched its first litigation against e-cig manufacturers illegally selling their products when it asked six district courts for permanent injunctions against six companies, David reports. The manufacturers — Morin Enterprises, Soul Vapor, Super Vape’z, Vapor Craft, Lucky's Convenience & Tobacco and Seditious Vapours — received warning letters in 2021 from the FDA. The agency said the companies failed to submit marketing applications and continued selling their vapes. Five of the companies failed to respond for comment. A Soul Vapor spokesperson told POLITICO in an email that the company is “cooperating fully with the FDA and the Department and Justice, and [has] no further comment at this time.”
| | | | TUNE IN TO THE PULSE CHECK PODCAST: Keep your finger on the pulse of the biggest stories in health care by listening to our daily Pulse Check podcast. POLITICO’s must-listen briefing decodes healthcare policy and politics, and delivers reality checks from health professionals on the front lines. SUBSCRIBE NOW AND START LISTENING . | | | | | | | | FDA ENDORSES NOVAVAX BOOSTER — The FDA on Wednesday authorized the Novavax Covid-19 vaccine as a first booster dose for those 18 and older who can’t or won’t get an mRNA vaccine. The booster dose is to be given at least six months after receiving a primary vaccine series. The CDC endorsed the booster the same day. More than 35,000 doses of Novavax vaccine had been administered in the U.S. as of Oct. 12, according to CDC data — a fraction of the nearly 627.9 million total doses given as of that date.
| | | | A message from UnitedHealth Group:   | | | | | | SCHWARTZ: CYBERSECURITY FINAL GUIDANCE COMING — The FDA intends to publish final guidance on medical device cybersecurity by the end of the current fiscal year, Suzanne Schwartz, director of CDRH's Office of Strategic Partnerships and Technological Innovation, told the Alliance for a Stronger FDA on Thursday. The agency executive also redoubled calls for new device shortage reporting requirements. “We have a history of having to deal with a shortage or a crisis literally as it was unfolding, which of course puts one, or puts a center, in very much a reactive mode,” Schwartz said. FDA LISTS LABS OFFERING MONKEYPOX LAB-DEVELOPED TESTS — Laboratories offering monkeypox tests they developed under the agency’s current policy are now listed by the FDA on its website . “While the FDA has not reviewed the laboratory’s validation of the listed tests and has not issued EUAs for these tests, we are providing this information to promote transparency,” the FDA said in an email.
| | | | STAY AHEAD OF THE CURVE: Our Future Pulse newsletter will continue to bring you the biggest stories at the intersection of technology and healthcare, but now five times a week. Want to know what’s next in health care? Sign up for our Future Pulse newsletter. If you aren’t already subscribed, follow this link to start receiving Future Pulse . | | | | | | | | U.S. HAS EXPERIMENTAL EBOLA VACCINE FOR UGANDA — The U.S. has developed an experimental Ebola vaccine aimed at stopping an outbreak that has killed 44 people in Uganda, POLITICO’s Carmen Paun reports. The vaccine successfully prevented severe disease and death in monkeys and was safe in Phase I trials. HHS officials are awaiting approval from the World Health Organization and the Ugandan government to begin testing it in the central African country.
| | | FDA advisers recommend removing preterm pregnancy drug Makena from the market, Lauren reports.
| | | A group of 16 senators on Thursday sent a letter to CMS Administrator Chiquita Brooks-LaSure, urging the agency to publish a proposed rule on transitional coverage for emerging technologies by the end of 2022.
| | A message from UnitedHealth Group: Beginning in 2023, UnitedHealthcare fully insured group members will pay $0 out of pocket on five life-saving medications: insulin for diabetes, epinephrine for allergic reactions, glucagon for hypoglycemia, naloxone for opioid overdoses, and albuterol for acute asthma attacks.
This is an important step to help drive affordability for patients and combat the high price of prescriptions, which are set and raised by drug manufacturers. We are committed to continuing to use our negotiation and clinical capabilities to help lower out-of-pocket costs for consumers. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
