A divided three-judge federal appeals court panel has ruled that a lower court was wrong to try to reverse entirely the FDA's approval of the abortion drug mifepristone. The panel did find, however, that the agency violated regulatory rules in making the drug more easily available and that those rules should be rolled back. In practice, nothing changes immediately, because the Supreme Court has blocked the lower court's order that the drug effectively be removed from the U.S. market — for now.
The case is pivotal for the future of reproductive health, as the pill is part of a regimen that is now the most common way American women terminate early pregnancies and is also widely used by doctors to manage miscarriages.
Meanwhile, as President Joe Biden's Inflation Reduction Act turns one, Medicare officials are preparing to unveil which 10 drugs will be the first to face price negotiation under the new law.
This week's panelists are Julie Rovner of KFF Health News, Shefali Luthra of The 19th, Sarah Karlin-Smith of the Pink Sheet, and Alice Miranda Ollstein of Politico.
Julie Rovner KFF Health News @jrovner.
Julie Rovner is chief Washington correspondent and host of KFF Health News' weekly health policy news podcast, "What the Health?" A noted expert on health policy issues, Julie is the author of the critically praised reference book "Health Care Politics and Policy A to Z," now in its third edition.
- Shefali Luthra The 19th@shefalil
- Sarah Karlin-Smith Pink Sheet@SarahKarlin
- Alice Miranda Ollstein Politico@AliceOllstein
Among the takeaways from this week's episode:
- Wednesday's federal appeals court decision siding with conservative medical groups challenging mifepristone regulations has perhaps the biggest implications for the drug's distribution via telemedicine, which has been key to securing abortion access for people in areas where abortion is unavailable.
- The ongoing legal threat to mifepristone is reverberating through the drug industry, as drugmakers worry challenges to the FDA's scientific authority could cause serious problems for future drug development — especially in an industry that takes big financial risks on getting products approved.
- Texas is suing Planned Parenthood over past Medicaid payments made to the program, charging that the health organization "defrauded" the state, even though the claims were made while a court had specifically allowed Planned Parenthood to remain in the program. Still, the lawsuit emphasizes just how far Texas has gone, and will go, to maintain the legal authority to not support Planned Parenthood, even in its non-abortion work.
- The federal government is expected to release the list of 10 pharmaceuticals subject to Medicare price negotiations by Sept. 1. The drugs' identities are the subject of much educated speculation, as Congress laid out in the law how drugs qualify for consideration — though even stakeholders in the drug industry are wondering which specific drugs will be up for discussion.
- A national survey of pharmacists finds drug shortages are widespread and leading to rationing at the pharmacy level. A lack of incentives to produce generic drugs is complicating supply-chain problems, leaving fewer options when there are manufacturing or other types of issues with a particular drugmaker.
Plus, for "extra credit" the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: Time's "She Wasn't Able to Get an Abortion. Now She's a Mom. Soon She'll Start 7th Grade," by Charlotte Alter.
Sarah Karlin-Smith: MIT Technology Review's "Microplastics Are Everywhere. What Does That Mean for Our Immune Systems"? by Jessica Hamzelou.
Shefali Luthra: The Atlantic's "Right Price, Wrong Politics," by Annie Lowrey.
Alice Miranda Ollstein: Politico's "We're on the Cusp of Another Psychedelic Era. But This Time Washington Is Along for the Ride," by Erin Schumaker and Katherine Ellen Foley.
Also mentioned in this week's episode:
- States Newsroom/The Georgia Recorder's "Study Cited by Texas Judge in Abortion-Pill Case Under Investigation," by Sofia Resnick.
- Stat's "From Drug Shortages to High Prices, U.S. System's Shortcomings Have Deep Roots," by Matthew Herper.
Francis Ying Audio producer Emmarie Huetteman Editor
This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.
Posted in: Healthcare News | Pharmaceutical News
Tags: Abortion, Drugs, Health Care, Manufacturing, Medicaid, Medicare, Pharmaceuticals, Pharmacy, Reproductive Health, Technology, Telemedicine