Axios Vitals: Abortion pill legal questions

Plus, oversight of Medicaid funding tool under scrutiny | Monday, April 10, 2023

Open in app View in browser   Presented By PhRMA   Axios Vitals By Tina Reed · Apr 10, 2023 Happy Monday, Vitals readers. Today's newsletter is 880 words or a 3.5-minute read.     1 big thing: FDA's power tested by dueling abortion pill rulings Photo: Amanda Andrade-Rhoades/For The Washington Post via Getty Images   Last week's dueling court rulings on abortion pills are refocusing attention on what legal powers the Food and Drug Administration has over prohibited drugs — and how it can decide whether or not to disregard the prohibition, Axios' Adriel Bettelheim and Oriana González write. The big picture: If a Texas federal judge's ruling stands, and the abortion drug mifepristone no longer has FDA approval, then manufacturing, selling, and distributing it will be outlawed. Yes but: Some legal experts say the agency has the discretion to chart a path forward and keep some semblance of the status quo. They cite a 1985 Supreme Court ruling that held agency decisions not to take enforcement actions aren't subject to judicial review. And, they note, there's already an established legal path for revoking a drug approval that involves public hearings and gives the manufacturer a say. Zoom in: The case for FDA enforcement discretion was laid out in the aftermath of Friday night's rulings by University of Pittsburgh law professor Greer Donley and Rachel Rebouche, dean of Temple University's Beasley School of Law, in the blog Abortion, Every Day. They note the FDA can issue a notice and lay out guidance about how it will respond to the court orders, and possibly reiterate the position that mifepristone is safe and should remain part of the medication abortion regimen. The agency would therefore comply with the Washington state federal court ruling. Of note: U.S. District Court Judge Matthew Kacsmaryk's decision attempts to go around the FDA, by not explicitly ordering the agency to do anything but by staying the effective date of the agency's approval. Yes, but: While issuing a notice and exercising discretion would assert the FDA's administrative power and maintain access to medication abortion, the legal tussle is still subject to many more twists and turns, and would ultimately take up the bigger question of how much authority a federal agency has. Go deeper.     2. Ruling highlights fight over abortion language A federal judge's 67-page decision to roll back FDA approval of mifepristone repeatedly borrowed terms from antiabortion advocates, such as "chemical abortion," rather than the generally accepted terms used by the medical community. Zoom in: In one example, a footnote in U.S. District Court Judge Matthew Kacsmaryk's ruling states "jurists often use the word 'fetus' to inaccurately identify unborn humans in unscientific ways. The word 'fetus' refers to a specific gestational stage of development, as opposed to the zygote, blastocyst, or embryo stages." But, "centering the language on a future state of a pregnancy is medically inaccurate," according to the American College of Obstetricians and Gynecologists in an online language guide. "Through eight weeks after last menstrual period, 'embryo.' After that point until delivery, 'fetus.'" Our thought bubble: For many, the language in the ruling cast doubt on Kacsmaryk's objectivity. But it also strays from offering accurate health information from some of the largest medical organizations in the nation. Read the rest.     3. COVID's role in increasing maternal mortality rates Illustration: Aïda Amer/Axios   The U.S. maternal mortality rate increased during the COVID-19 pandemic, disproportionately impacting Black women, with far higher odds of severe complications among pregnant patients with COVID infection at delivery, a new analysis published in JAMA Network Open found, Axios' Arielle Dreher and Oriana write. Why it matters: The United States has the highest maternal mortality rate among developed countries, and the pandemic made it worse — in 2021, 1,205 women died of maternal causes, data from the CDC show, compared to 861 in 2020 and 754 in 2019. Driving the news: The JAMA analysis, led by researchers from the University of Southern California, found the mortality risk of pregnant patients with COVID-19 at delivery between March 2020 and December 2020 was 14 times higher than those without the virus. The big picture: Risk factors that made someone more susceptible to severe COVID-19 are also risk factors that make a pregnancy higher risk, including having higher blood pressure, cholesterol and diabetes. Previous studies have also found contributors to the high maternal mortality rate during the pandemic have included a lag in COVID-19 vaccination in pregnant people due to concerns over the potential effects of the vaccine, despite studies showing they are safe. Share this story.     A message from PhRMA The 3 largest PBMs denied coverage to over 1,150 medicines last year     And all three own or are owned by insurance companies. They often own your pharmacy too. That includes medicines that could lower your costs at the pharmacy. Pharmacy benefit managers (PBMs) are putting their profits before you. Haven't heard about this? That's by design.     4. Where that Medicaid funding is going Illustration: Sarah Grillo/Axios   An obscure Medicaid funding opportunity known as "directed payments" has allowed states to channel money to boost payments to providers, but appears to have limited oversight, a KHN report published in USA Today found. Driving the news: States received more than $25 billion last year through this program. Both the Government Accountability Office, as well as the Congressional advisory panel known as MACPAC, have said the funding needs more transparency. Between the lines: While much attention has been focused on how much money is flowing through Medicaid expansion, non-expansion states have used this tool to directly bolster hospital and provider funding rather than increase coverage for patients, Democratic officials told KHN. Yes, but: States like California, an expansion state, have also reported bringing in more than $6 billion just last year in new federal funds through directed payments, KHN reports.     5. While you were weekending Illustration: Aïda Amer/Axios   🏥 Big hospital property owner expects earnings hit. (Wall Street Journal) 👉 How WA's plan to transform its mental health system has faltered. (The Seattle Times) ✂️ Most oppose Social Security and Medicare cuts, an AP-NORC poll finds. (The Associated Press) 💰How a lobbying blitz led to weaker Medicare Advantage reforms. (The Hill)     A message from PhRMA Did you know that just 3 PBMs control 80% of all prescriptions?     And all three own or are owned by insurance companies. They often own your pharmacy too. This extreme market consolidation steers you toward pharmacies that make them more money — regardless of what's best or convenient for you. Haven't heard about this? That's by design.   Thanks for reading, and thanks to senior health care editor Adriel Bettelheim and copy editor Azi Najafi for the edits. 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