Axios Vitals: Pharma warning

Plus, hospitals to get a raise | Tuesday, April 11, 2023

Open in app View in browser   Presented By PhRMA   Axios Vitals By Tina Reed · Apr 11, 2023 Happy Tuesday, Vitals readers. Today's newsletter is 977 words or a 4-minute read. Join Axios' Niala Boodhoo tomorrow at 1pm GMT (9am ET) in Oxford, U.K., at the Skoll World Forum for an event laying out a global road map for solving some of the world's biggest problems. Register here to attend in person or virtually.     1 big thing: Pharma condemns Texas abortion drug ruling Illustration: Brendan Lynch/Axios   Drug and biotech companies are coming to the defense of the Food and Drug Administration and assailing a Texas court's ruling on abortion pills, saying it sets a dangerous precedent for undermining federal drug approvals, Axios' Adriel Bettelheim and I report. Why it matters: If the ruling is upheld, FDA decisions could be stayed by individual judges, injecting chaos into the regulatory process and creating new potential liabilities for manufacturers. U.S. District Court Judge Matthew Kacsmaryk, among other things, found doctors had standing to legally challenge the FDA's approval of the abortion drug mifepristone, because they had to treat patients who'd had ill effects from taking it. The industry says adding such uncertainty to the already risky work of developing drugs could chill investment in new cures. What they are saying: "Judicial activism will not stop here," a group of more than 250 drug industry leaders, including Pfizer CEO Albert Bourla, as well as other drug company and biotech execs and investors wrote in a letter on Monday. "If courts can overturn drug approvals without regard for science or evidence ... any medicine is at risk for the same outcome as mifepristone." In an interview on CNN, HHS Secretary Xavier Becerra laid out a list of potential targets. "You're talking about our vaccines. You're talking about insulin. You're talking about the new Alzheimer's drugs that may come on," he said. "If a judge decides to substitute his preference, his personal opinion, for that of scientists and medical professionals, which drug isn't subject to some kind of legal challenge?" Catch up quick: The industry statements came hours before the Justice Department and a manufacturer of mifepristone appealed Kacsmaryk's ruling. The FDA also asked a federal court in Washington state — which released a dueling opinion on Friday that would maintain the status quo on mifepristone — to clarify how it can move forward with that ruling if the Texas injunction prevails. The matter is expected to end up at the Supreme Court. What we're watching: In recent campaign cycles, the drug industry has favored Republicans, per KHN. That dynamic could change if Democrats steer efforts to prop up FDA's authority and maintain the status quo. Related: Democrats squeeze vulnerable Republicans over abortion pill ruling.     2. The next Warp Speed Photo: Win McNamee/Getty Images   The White House is launching a $5 billion effort to develop next-generation COVID-19 vaccines and rekindle some of the momentum from Operation Warp Speed, the Washington Post reports. Why it matters: The initiative aims to create more durable protection in the face of a fast-changing virus and lackluster public interest in annual shots. White House coronavirus coordinator Ashish Jha, head of the COVID task force which is disbanding next month, told the Post the effort will support creating long-lasting monoclonal antibodies, develop vaccines that produce mucosal immunity and accelerate work on pan-coronavirus vaccines. Catch up quick: Experts have been calling for a widened focus with other vaccine technologies that boost immunity through mucous membranes and establish "sterilizing immunity" against COVID, as well as a so-called "universal" coronavirus vaccine. What to watch: The $5 billion for the effort came after HHS was directed by the White House to shift funds for coronavirus testing, personal protective gear and other priorities, The Post reports. Expect another clash with Republicans over vaccine strategy.     3. Hospitals get slight pay boost from feds Hospitals are in line for a 2.8% pay increase, or $3.3 billion in additional funding in fiscal year 2024, under a proposed inpatient payment rule Medicare administrators released on Monday, Axios' Arielle Dreher and Maya Goldman write. Why it matters: Hospital margins are finally starting to stabilize after what many called the worst year for their finances in 2022. Yes, but: Payments to offset the costs of charity care for low-income patients will decrease by $115 million. The Centers for Medicare and Medicaid Services heard hospital groups' request for exploring additional payments to safety-net hospitals, however, and has asked for public comment on the matter. The intrigue: CMS is targeting equity initiatives and measures to evaluate hospitals in the future. CMS is proposing changes to how they score hospitals, including 15 new equity categorizations that would include more data collection. The agency is proposing an increased reimbursement for providers treating patients experiencing homelessness as a way to address one of the major social determinants of health. The new rule also clarifies that hospitals won't receive add-on payments for new COVID-19 treatments beginning in fiscal year 2024, so long as the public health emergency ends in May as currently planned. Read more.     A message from PhRMA Insurers and PBMs don't pay full price for your medicines. So why do you?     Insurers and pharmacy benefit managers (PBMs) get discounts on medicines. Surprised? These savings can reduce the cost of some brand medicines by 50% or more, but insurers and PBMs aren't required to share these savings with you. See what else they don't want you to know.     4. Data du jour: Few pediatricians address gun safety Reproduced from Pew Research Center; Chart: Axios Visuals Doctors seldom ask their patients about whether they keep firearms at home or discuss gun safety with them, a new survey from the Kaiser Family Foundation found, Arielle writes. Why it matters: As Axios' Erica Pandey reports, gun deaths are steadily increasing among children and teens nationwide, and gun violence is the leading cause of premature death in the United States. Some professional medical groups consider it a public health crisis. By the numbers: Just 14% of adults surveyed by KFF in March said their health care provider has asked them about gun ownership, and just 26% of adults said their child's pediatrician asked about having guns in the home. One in five adults say they have been threatened with a gun at least once in their life, and one in five say a family member has been killed with a gun, including by suicide. Black and Hispanic adults bear a disproportionate burden from gun violence, the KFF survey found. The United States is alone among developed nations in having firearm deaths account for one of the top four causes of mortality and the leading cause of death for children and teens. Share this story.     5. Catch up quick 💊 Why the hell is it so hard to get Adderall right now? (Vice) 👀 In two-state Texarkana, Medicaid expansion creates widening access divide. (Public Health Watch) 🖋️ Biden signs bill ending Covid national emergency. (NBC News)     A message from PhRMA What's a pharmacy benefit manager (PBM)?     They decide if medicines get covered and what people pay for them, regardless of what your doctor prescribes. These middlemen are putting their profits before your wellness. And getting between you and your doctor. You need to see what's going on.   Thanks for reading, and thanks to senior health care editor Adriel Bettelheim and copy editor Azi Najafi for the edits. Dive deeper into the future of health care Axios Pro is your personal health care industry analyst, here to help you make the news actionable and anticipate future outcomes. Subscribe today.   Axios thanks our partners for supporting our newsletters. Sponsorship has no influence on editorial content. Axios, 3100 Clarendon B‌lvd, Arlington VA 22201   You received this email because you signed up for newsletters from Axios. To stop receiving this newsletter, unsubscribe or manage your email preferences.   Was this email forwarded to you? Sign up now to get Axios in your inbox.   Follow Axios on social media: