Axios Vitals: FDA revamp

Plus, why age matters | Wednesday, February 01, 2023

Open in app View in browser   Presented By PhRMA   Axios Vitals By Tina Reed · Feb 01, 2023 Good morning, Vitals readers. Today's newsletter is 1,006 words or a 4-minute read. 🧠 1 research thing: Sepsis is a leading cause of hospitalization and death worldwide. A new study in the Journal of the American Heart Association this morning found that threat can linger among patients long after they've been discharged. People who recovered from sepsis had a 38% higher risk of rehospitalization for all causes and a 43% higher risk of heading back to the hospital for cardiovascular events, the study found.     1 big thing: Republicans break with another historical ally: doctors Data: OpenSecrets; Chart: Will Chase/Axios Republicans' historical alliance with the nation's leading physicians' group has deteriorated to the point where several elected doctors are openly critical of the organization and what they refer to as its "woke" policies, Axios' Caitlin Owens and Victoria Knight report. Why it matters: The fractured relationship, similar to the GOP's relationship with the U.S. Chamber of Commerce, points to a substantial change in Washington's power dynamics under a newly empowered GOP House. Driving the news: Several GOP doctors voiced frustrations with the American Medical Association in interviews with Axios, frequently citing the organization's positions on issues like abortion and gender-affirming care. Some members of the congressional Doctors Caucus said they met with AMA leadership last week. "It looks like all you care about are woke issues," said Rep. Brad Wenstrup (R-Ohio), one of the co-chairs of the caucus, defining the group's policies on abortion and transgender issues as "woke" because they don't align with the Doctors Caucus' "pro-life" stance and feel like a mandate to practice medicine they don't agree with. Sen. Rand Paul (R-Ky.) told Axios that the AMA "has been very much left-wing or left-of-center for a long time ... If I had time, I could probably tell you 20 things the AMA has done in the last five years that I disagree with." The big picture: The fractured relationship represents major shifts within both the GOP and the AMA, including an increasing openness by the physicians' group to a larger role for the federal government in the health care system. But it's been the group's positions on major social issues that may have caused the most friction with congressional conservatives. "I think the AMA, it's been going on for maybe longer, but this summer when they were up on the Hill testifying about gun violence and to some extent the Dobbs decision, that might have been the end," said Joe Grogan, a University of Southern California Schaeffer Center senior fellow and former Trump administration official. The other side: Jack Resneck, president of the AMA, told Axios in an interview that while he knows some of AMA's policies may be seen as controversial, no doctor is likely to agree with all of the group's stances. "With this group of physicians in Congress we do have alignment," said Resneck, who cited prior authorization and payment rates as issues with bipartisan support. A version of this story was published first on Axios Pro. Get news like this by subscribing. Use code POLICY100 which gives you $100 off.     2. What the end of PHE will — and won't — mean Illustration: Brendan Lynch/Axios   The May 11 planned expiration of the COVID public health emergency could cause major disruptions for some health care providers while barely creating a ripple in other industry segments — at least for now. What it affects: The ending of the PHE will take pricing and coverage of COVID-19 vaccines and other countermeasures out of the government's hands and move it to the commercial market. The end of PHE will end flexibility that allows certain clinicians to prescribe controlled substances to patients they haven't seen in person via telehealth, per KFF. Waivers for nursing homes, home care and community-based services could go away, per the American Health Care Association and National Center for Assisted Living. What it won't affect: Lawmakers already agreed on a timeline to begin unwinding Medicaid continuous coverage protection on April 1, a process that could lead to millions becoming uninsured. The expiration of the emergency also won't impact most telehealth flexibilities, which were extended through 2024. It also doesn't impact FDA's ability to authorize devices, tests, treatments or vaccines for emergency use, and existing emergency use authorizations for products will remain in effect, the agency said. Share this story.     3. Califf reveals plan to reorg FDA food programs FDA commissioner Robert Califf. Photo: Nathan Posner/Anadolu Agency via Getty Images   The food portion of the FDA should be reorganized under a new deputy commissioner for Human Foods, FDA commissioner Robert Califf announced Tuesday. Why it matters: The FDA has come under significant scrutiny in recent years for its oversight of food products, culminating with last year's baby formula crisis. Califf promised a bold response after an independent review last year found that the agency's food division appeared at times "sluggish and nonresponsive to public health concerns." Driving the news: Under the proposed plan, several existing centers "will be unified into a newly envisioned organization called the Human Foods Program," per the announcement. The new deputy commissioner "will have decision-making authority over policy, strategy and regulatory program activities" within the program, Califf said. That deputy commissioner will report directly to the FDA commissioner, per Califf. Between the lines: As part of the plan, Califf suggested the creation of a "Center for Excellence in Nutrition," as well as an office to better integrate the FDA's food safety and response activities with state and local partners and an advisory committee of outside experts.     A message from PhRMA Data show PBMs shift costs to patients     Costly out-of-pocket expenses tied to deductible and coinsurance requirements are a leading concern for patients with commercial insurance. New IQVIA data break down how insurers and their PBMs are impacting how patients access and afford their medicines.     4. Age really does matter ... apparently Illustration: Shoshana Gordon/Axios   The year when a breast cancer patient turns 70 can make a big difference in the kind of treatment her doctor recommends, according to a study published in the International Journal for Radiation Oncology, Biology, Physics. Why it matters: Researchers said they expected to see recommendations for post-surgery radiation in breast cancer patients to decline gradually as expected lifespan shortened. Instead saw a steep cliff occur in this particular year. What they're saying: "Our decision-making is not as good as we think it is," Suzanne Evans, senior author of the study and a professor of therapeutic radiology at Yale Cancer Center, told Axios. "There are a lot of rules of thumb ... we use in all of our decision-making throughout life, even in medicine, and I think it's super important we don't overweigh any one factor and we look at the whole picture." Our thought bubble: Turning a year older could have an outsize impact on treatment for other conditions, like heart disease.     5. Catch up quick 👀 Pro-Russia hacker group targets hospital websites in several states. (Detroit Free Press) 📉 Pfizer forecasts a steep decline in COVID vaccine and drug sales. (BioPharma Dive) 👉 Trump unveils a sweeping attack on trans rights ahead of 2024. (Axios) 💰 Nursing home owners drained cash during the pandemic while residents deteriorated. (KHN)     A message from PhRMA Patients are frustrated     New data from IQVIA reveal patients with deductibles and coinsurance are more likely to abandon their medicines than patients with copays. The reason: Insurers and their PBMs shift the costs of covered medicines onto their patients. That's not fair. Learn more.   Did someone forward this email? Subscribe here. Thanks for reading, and thanks to senior editor Adriel Bettelheim and senior copy editor Bryan McBournie for the edits. Your personal policy analyst is here. Track health care policy formation at every step of the process with Axios Pro. Talk to our sales team today.   Axios thanks our partners for supporting our newsletters. Sponsorship has no influence on editorial content. 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