A three-judge panel of the Federal Court of Appeals was divided, ruling that a lower court had been wrong in seeking to completely revoke FDA approval of the abortion drug mifepristone. However, the panel found that the authorities had violated regulatory rules to make the drug more readily available and that those rules should be rescinded. In reality, nothing will change immediately. That’s because the Supreme Court has so far stayed a lower court’s order to effectively exclude the drug from the US market.
This lawsuit is of great importance to the future of reproductive health. Because the pill is now the most common way American women terminate early pregnancies and is part of a regimen widely used by doctors to manage miscarriages.
Meanwhile, as President Joe Biden’s Inflation Control Act enters into its first year, Medicare officials are preparing to announce the 10 drugs that will face price negotiations first under the new law. .
This week’s panelists are Julie Lobner of KFF Health News, Shefali Rusla of The 19th, Sarah Karlin Smith of Pinksheets and Alice Miranda Allstein of Politico.
the host
Julie Rovner KFF Health News @jrovner.
Julie Rovner is Washington’s chief 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 her critically acclaimed reference book Health Politics and Policy A to Z, now in its third edition.
panelist
Here are the takeaways from this week’s episode:
- Wednesday’s federal appeals court ruling, which sided with conservative medical groups challenging mifepristone regulation, has likely been key to ensuring access for people in areas where abortion is not available. Telemedicine drug delivery will have the greatest impact.
- Continued legal threats to mifepristone have echoed in the pharmaceutical industry, with pharmaceutical companies concerned that challenges to the FDA’s scientific authority could pose serious challenges to future drug development. , especially in an industry that takes significant financial risk in product approval.
- Texas has previously criticized the Planned Parenting Program, accusing the health care provider of “frauding” the state, even though the request was made while the court specifically granted him to remain in the program. It’s suing the Family Planning Agency over paid Medicaid payments. Still, the lawsuit highlights how far Texas has gone—and will continue to go—to maintain its legal authority not to support family planning, even in efforts other than abortion.
- By September 1, the federal government plans to release a list of 10 drugs that will be subject to Medicare price negotiations. Because Congress statutes how drugs are subject to review, the identity of drugs is subject to much educated speculation, including by stakeholders. The pharmaceutical industry is wondering which specific drugs will be the subject of debate.
- A national survey of pharmacists found widespread shortages of medicines, leading to distribution at the pharmacy level. The lack of incentives to produce generic drugs complicates supply chain issues, leaving certain pharmaceutical companies with fewer options when manufacturing or other types of problems arise.
Additionally, as “extra credit”, I’ll suggest a health policy article that the panelists read this week that you think you should read too.
Julie Rovner: Time magazine, “She couldn’t have an abortion. Now she’s a mother. Soon to be in the seventh grade.” by Charlotte Alter.
Sarah Carlin Smith: “Microplastics are everywhere. What does that mean for our immune system?” by Jessica Hamzellow in MIT Technology Review.
Shefari Lutra: “Right Prices, Wrong Politics” by Annie Laurie for The Atlantic.
Alice Miranda Allstein: “We are at the height of a new psychedelic era, but now Washington is on board,” by Erin Shoemaker and Catherine Ellen Foley of Politico.
Also mentioned in this week’s episode:
credit
Francis Yin Audio Producer Emary Hüttemann Editor
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