Califf: Potential benefits of Twitter exceed risks

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

Nov 01, 2022 View in browser   By David Lim , Lauren Gardner and Katherine Ellen Foley Driving the Day The U.S. is seeing a sudden surge in respiratory syncytial virus cases, especially among children. | AP Photo WHERE ARE THE RSV VACCINES? — The role of RSV, or respiratory syncytial virus, in driving up pediatric hospitalizations so early in the cold-weather virus season is drawing attention to the lack of vaccines and therapies to prevent and treat it, Lauren and Katherine report. RSV hasn't enjoyed the same notoriety as the flu and, more recently, Covid-19 in the public consciousness, but that could change after this year's already-historic case surge — and the pharmaceutical options in the pipeline that could soon hit the market. Pfizer and GSK have each released data in the past few months showing promising efficacy of their vaccine candidates geared toward adults 60 and older — the other side of the population prone to the worst effects of the virus — with plans to file for regulatory approval this year. Immunizations for children are further behind. Moderna is the only company with an option for babies in an early-stage trial. Pfizer is studying a third option: Vaccinating pregnant people so their antibodies transfer to their fetuses, offering their babies some protection during the early months of life. The company released topline data today from its late-stage RSV vaccine trial in that group, showing a nearly 82 percent efficacy rate against severe lower respiratory tract infections from the virus in infants up to three months old and 69 percent efficacy in babies up to six months. IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Have you gotten your flu shot yet? 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 ). TODAY ON OUR PULSE CHECK PODCAST, Lauren talks with Alice Miranda Ollstein about how the increase in RSV cases casts attention on a handful of drugmakers with vaccines in the pipeline. Plus, Alice's dispatch from Michigan where Gov. Gretchen Whitmer is trying to make an economic case for abortion rights. Listen to today's Pulse Check podcast Eye on the FDA The FDA is reportedly worried that doctors are prescribing abortion drugs to women who aren't pregnant. | Jeff Roberson/AP Photo FDA: PROVIDING ABORTION PILL BEFORE PREGNANCY IS POTENTIALLY RISKY — The FDA is concerned that healthcare providers who preemptively prescribe medications to induce abortions could lead patients to use the drugs unsupervised , an agency spokesperson told POLITICO's Ben Leonard on Friday. "The FDA is concerned about the advance prescribing of mifepristone for this use," said an FDA spokesperson granted anonymity to describe sensitive agency policies. "Mifepristone is not approved for advance provision of a medical abortion." Abortion medication is regulated more tightly by the FDA than other drugs, restricting how the regimen can be prescribed. However, as of last December, providers, including those who work in telehealth, can prescribe mifepristone via a virtual appointment and mail the medication. The FDA spokesperson said the agency is concerned that if patients were to take mifepristone weeks or months after getting a prescription filled, a medical professional might be unable to assess whether a pregnancy is intrauterine or ectopic or to date pregnancies properly. The stance puts the Biden administration — which has publicly pledged to do everything within its power to preserve access to abortion — at odds with some abortion providers and abortion-rights activists. The FDA spokesperson declined to comment on whether the agency is considering updating its prescribing restrictions. FDA WILL KEEP TWEETING — Days after Elon Musk purchased Twitter, FDA Commissioner Robert Califf slammed "the kind of divisive and hateful language that we've seen on Twitter in recent days" as unacceptable. "I grew up in the segregated South, and our society is still struggling to progress past a part of the history that I experienced first-hand. There's absolutely no place for racism or antisemitism in our society," Califf tweeted on Monday . Califf said that while it would be easy for the FDA to abandon Twitter, the agency will continue to use the platform to communicate health information. Twitter "As we like to say, 'the potential benefits (of staying on Twitter) exceed the risk' at this time," Califf added . Tobacco EARLY TAKEAWAYS FROM COMMENTS TO REAGAN-UDALL'S EXPERT PANEL — As the Reagan-Udall Foundation undertakes its review of the FDA's tobacco program, a number of legal, industry and public health experts are presenting the expert panel with written and oral comments about the major issues they see with the Center for Tobacco Products' processes and operations, Katherine reports. The biggest takeaways so far: The new tobacco product application process needs more transparency and agility. The FDA needs to be clear about what products are legally allowed to be sold. CTP staff needs to be able to focus on science without political interference. Eyes emoji: Several anonymous commenters who self-identify as FDA employees said they were extremely concerned about undue pressure during the scientific review process. "Politics are being permitted to drive the science and even limit or alter science-based decisions," one employee wrote. "There is also no strategic, logical plan to address issues in a reason-based order. We are constantly being asked to focus on fixing a leaky faucet on the Titanic as it sinks." The FDA rejects these characterizations: "CTP's decisions are based on a scientific review of the data submitted for each product," said an FDA spokesperson in an emailed statement. JUDGE GRANTS STAY ON LOGIC'S MENTHOL MARKETING DENIAL ORDERS — For now, Logic's menthol capsules for its Logic Pro and Logic Power vapes — devices that received marketing authorization in March — can remain on the market thanks to a temporary stay granted by a judge in the U.S. Court of Appeals in the Third Circuit, Katherine reports. MEDICAL DEVICES FDA CONVENES PULSE OXIMETER ADVISORY COMMITTEE — The FDA convenes an advisory committee today to examine concerns about the accuracy of pulse oximeters for people with darker skin pigmentation. "There is mounting evidence from real-world studies that suggest performance of pulse oximeters can be affected by skin pigmentation," the FDA's executive summary states. The panel of outside experts is not slated to vote on any questions but is being asked by the FDA to discuss a variety of questions , including whether any clinical evidence demonstrates disparate performance in patients with darker skin, and if so, whether the experts believe that could lead to increased risks for those patients. The agency is also asking panelists to discuss whether changing labeling for the devices could help reduce the use of inaccurate readings. FDA: CONSIDER ALTERNATIVES FOR MRI-GUIDED BREAST BIOPSIES — Providers should tell patients to get procedures at other medical facilities if MRI breast biopsy grid plates and other disposables are unavailable because of shortages, the FDA said Monday in a letter to them. TRACHEOSTOMY TUBES IN SHORTAGE — Shortages of tracheostomy tubes used to help patients breathe after surgery disproportionately impact pediatric patients, the FDA said in a safety communication issued Monday . Challenges in obtaining the raw materials used to make the tubes are causing the short supply. "A shortage of Bivona tracheostomy tubes is more likely to impact pediatric patients because the supply of alternative tubes with similar functionality may be limited," the safety communication states. "While there are other FDA-cleared tracheostomy tubes for pediatric patients, there may not be enough available to adequately mitigate the shortage." Coming Up in Pharma TUESDAY: Pfizer holds its quarterly earnings call at 10 a.m. EDT. THURSDAY: Moderna holds its earnings call at 8 a.m. EDT. Pharma Moves Holly Grosholz is the American Clinical Laboratory Association's new director of government affairs. Document Drawer The FDA issued draft guidance for sponsors containing recommendations on how to track growth and pubertal development in clinical trials involving children with rare and common diseases. The FDA published final guidance outlining its regulatory approach toward human cells, tissues or cellular or tissue-based products. CMS issued a final rule outlining Medicare home health payment rates for calendar year 2023. The agency also issued a final rule outlining payment rates for dialysis treatment by an end-stage renal disease facility to patients with acute kidney injury.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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