During the past several turbulent weeks for the U.S. health care system, rulings in the case Alliance for Hippocratic Medicine v. FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific review process to approve new drug applications. While the U.S. Supreme Court acted on the afternoon of Friday, April 21, 2023 to preserve access to the drug mifepristone while the case continues in the United States Court of Appeals for the Fifth Circuit, the future of mifepristone—and the FDA’s authority to approve new drugs—will continue to be debated on appeal.
On November 18, 2022, the Alliance Defending Freedom (“ADF”), a conservative legal group, filed a motion with the federal district court in the Northern District of Texas against the U.S. Food and Drug Administration (“FDA”) to withdraw approval of Mifepristone, an FDA-approved drug used to end pregnancies in the first trimester.[1] While this case addresses access to a single product and was prompted by abortion opponents’ efforts to eliminate access to medication abortion, a loss for FDA in this case could have far broader implications.
Blog Editors
Recent Updates
- New Proposed Federal Legislation Takes Aim at Concerns Regarding Perceived “Looting” of Health Care Systems by Private Equity Investors
- Podcast: The Future of Laboratory Testing Just Got a Little Clearer - FDA's Final Rule on LDTs – Diagnosing Health Care
- How Does the End of Chevron Deference Change the Relationship Between the Health Care Industry, Federal Regulators, and Congress?
- Podcast: Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court – Diagnosing Health Care
- Thoughts: AB 3129 Expands Its Reach