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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 | PROGRAMMING NOTE: Prescription Pulse won't publish from Monday, Aug. 28, through Tuesday, Sept. 5. We’ll be back in your inbox on Wednesday, Sept. 6.
| | |  The FDA and the FTC are updating TV and radio advertising standards for prescription drugs, but some consumer health advocates say they should also focus on advertisements on social media like TikTok. | Drew Angerer/Getty Images | PHARMA’S ONLINE INFLUENCE — The White House budget office is reviewing a final FDA rule to update standards for radio and TV prescription drug ads, raising the possibility that pharma companies would need to alter how they market their medications to consumers inundated with catchy jingles during their evening programming. But some consumer health advocates and pharmacists are concerned that the FDA and the FTC aren’t doing enough to monitor where more and more people see ads touting pills and treatments — social media, particularly influencers. It’s a tricky area for oversight: The FDA’s domain in the advertising sphere falls squarely on drug manufacturers, packers and distributors. Kim Kardashian’s Instagram endorsement of a morning sickness drug caught the agency’s attention in 2015 for failing to disclose the post was an ad and omitting side-effect information — drugmaker Duchesnay got a warning from regulators as a result. On the broadcast side, Khloe Kardashian’s gig as a spokesperson for migraine drug Nurtec landed maker Biohaven Pharmaceuticals in hot water, too, for similar violations. Other levels of influence: But some advocates worry about influencers who might not have a Kardashian’s name recognition but are well known in online circles with thousands of followers. Marketing companies tend to facilitate unbranded campaigns between influencers and drug companies where the social media account drives traffic to an educational website — say, about quitting smoking — that’s actually sponsored by the maker of a drug geared toward the issue. And with more young people getting information from apps like TikTok, some say regulators should do more to ensure those online spaces present responsible drug information. The coming rule: The big issue at play in the forthcoming rule is whether the FDA decides to require drugmakers to superimpose text explaining a drug’s side effects and interactions on the screen in addition to audio describing the same information. Trade group PhRMA argues the visual component could confuse consumers and discourage appropriate prescriptions by overemphasizing a drug’s risks. IT’S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Is everyone on vacation this week except for us? Send news, tips and coffee date invites to Lauren Gardner (lgardner@politico.com or @Gardner_LM), David Lim (dlim@politico.com or @davidalim) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, your host Ben talks with POLITICO's Mia McCarthy about her reporting on the first locally transmitted malaria cases reported in the U.S. in 20 years — a mysterious reemergence that's puzzling public health experts.
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The FDA has approved a vaccine for pregnant people that will help protect their infants up to 6 months old from RSV. | Rogelio V. Solis/AP Photo | FDA ENDORSES MATERNAL RSV SHOT — In a first, the FDA approved Pfizer’s respiratory syncytial virus vaccine, Abrysvo, on Monday for pregnant people, the latest in a suite of medical innovations targeting the virus’ impact on vulnerable populations. The shot would be administered to pregnant people between 32 and 36 weeks’ gestation, with protection passing through to babies. That immunity would help protect infants up to 6 months old when they are most susceptible to serious outcomes from RSV infection. The CDC may need to weigh in on how parents should consider the vaccine against a recently approved monoclonal antibody shot for babies born before or during an RSV season. The FDA is requiring Pfizer to conduct postmarketing studies about the risks of preterm birth and preeclampsia in vaccine recipients. The agency said not enough data is available to establish or exclude a causal link between preterm birth and the vaccine.
| | | | DOWNLOAD THE POLITICO APP: Stay in the know with the POLITICO mobile app, featuring timely political news, insights and analysis from the best journalists in the business. The sleek and navigable design offers a convenient way to access POLITICO's scoops and groundbreaking reporting. Don’t miss out on the app you can rely on for the news you need. DOWNLOAD FOR iOS – DOWNLOAD FOR ANDROID. | | | | | | | | SPEED UP THE CONTRACT — Pharmacies and the Biden administration are attempting to finalize contracts that would allow uninsured Americans to be administered free updated Covid shots as early as mid-September, POLITICO’s Adam Cancryn and David report. POLITICO and other media outlets reported last week that Americans without health insurance would need to wait until mid-October to get no-cost shots at pharmacies but could obtain an updated vaccine from community health centers and some providers as soon as they are rolled out, which is expected the third week of September. “They are talking about ways to do it earlier, but nothing is set in stone,” one of the people granted anonymity to discuss the contracts said. In response to questions about the agency’s timeline, CDC spokesperson Kathleen Conley said only that contract negotiations are still underway and the agency can’t say when pharmacies will be able to distribute vaccines to the uninsured until those agreements are finalized.
| | | | TEVA, GLENMARK SETTLE PRICE-FIXING CASE — Two major generic drug companies agreed Monday to settle criminal price-fixing charges with the Justice Department after a nearly decade-long investigation, including the unusual move to sell off the drugs involved, POLITICO’s Josh Sisco reports. The U.S. arms of Israel-based Teva and India-based Glenmark will pay $225 million and $30 million, respectively, according to court filings. The companies agreed to enter into deferred prosecution agreements, a resolution in which charges are suspended but a company must admit wrongdoing and comply with the terms of the agreement. Both companies agreed to sell off their operations that make the cholesterol drug pravastatin. Companies typically pay criminal fines to settle antitrust charges instead of selling off lines of business. DOJ UNCOVERS LAB FRAUD — The Department of Justice said the owner of LabSolutions, Minal Patel, has been sentenced to 27 years in prison for his role in a scheme in which $463 million in unnecessary genetic and other laboratory testing charges were submitted to Medicare for reimbursement. The testing was procured through bribes and kickbacks paid to patient brokers, according to the DOJ. “In one of the largest genetic testing fraud cases ever tried to verdict, today’s sentence makes clear that the Department will seek justice for those who put profits above patient care, including owners and executives,” Acting Assistant Attorney General Nicole Argentieri of the Justice Department’s Criminal Division said in a press release.
| | | | MODERNA ENLISTS CANCER VACCINE PARTNER — Moderna and CARsgen, a Chinese CAR T-cell therapy company, have made a deal to test a treatment candidate with the American firm’s mRNA cancer shot.
| | Jeffrey Nesbit is now HHS’ assistant secretary for public affairs. He was most recently the Social Security Administration’s deputy commissioner for communications and served as former FDA Commissioner David Kessler’s public affairs chief. The Pharmaceutical Care Management Association has hired former GOP congressman Ryan Costello. Baxter appointed former Quest Diagnostics CEO Steve Rusckowski to its board of directors.
| | | A new study published in Nature Medicine that examined electronic medical records from VA databases found that even those who had mild Covid-19 have heightened risk for certain long Covid symptoms after two years, The Washington Post’s Amy Goldstein reports.
| | The FDA said Monday it will not add ephedrine sulfate and hydroxychloroquine sulfate to its 503B bulks list of drug substances that have a clinical need for use by compounding outsourcing facilities. CMS published draft guidance Monday outlining the details of an Inflation Reduction Act program intended to allow people with Medicare Part D to spread out-of-pocket costs over a calendar year, starting in 2025.
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