UPDATE: Late in the evening of September 28, the House defeated H.R. 4368 by a vote of 191-237, with 27 Republicans voting against the bill. It was the only one of the four appropriations bills to fail.

Editor’s Note: This post was originally published at 11:15 PM EST on September 27, 2023 while the House of Representatives was still voting on amendments to other appropriations bills.

A group of conservative Republicans in the House of Representatives’ proposed Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 (H.R. 4368) would rescind the Food and Drug Administration (FDA)’s January 2023 change to the Risk Evaluation and Mitigation Strategy (REMS) program to allow certified retail pharmacies to dispense mifepristone as part of a medication abortion regimen. The proposal would effectively limit retail pharmacy dispensing of the only medication that is labeled for medication abortion.Continue Reading GOP House Bill Proposes Repeal of Retail Pharmacy Dispensing of Mifepristone

On April 7, 2023, only minutes apart, two federal district courts issued rulings on cases challenging the Food and Drug Administration’s regulations governing mifepristone, a key medication for women seeking an abortion. Both rulings faulted the FDA’s handling of the approval and its subsequent restrictions on the dispensing of mifepristone, but the two rulings came to very different conclusions as to what the availability of the drug should be.

Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued a 67-page opinion ordering that the FDA’s initial approval of the drug, which was approved in 2000, should be stayed pending the court’s full review of the merits of the case. The court then stayed its own order for seven days to allow the FDA to appeal to the U.S. Court of Appeals for the Fifth Circuit.

Just minutes later, Judge Thomas Rice of the U.S. District Court for the Eastern District of Washington issued a 31-page opinion ordering FDA and HHS not to make any changes to the availability of mifepristone under the current operative Risk Evaluation and Mitigation Strategy (REMS) program, which requires the drug to be prescribed and dispensed only by certified providers, among other requirements. Unlike Judge Kacsmaryk, whose injunction has nationwide effect, Judge Rice limited the effect of his order to only the 17 states and the District of Columbia who brought the challenge in his court. The 17 plaintiff states in this lawsuit are: Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington and the District of Columbia.

The most difficult-to-reconcile aspect of the two orders is the fact that Judge Kacsmaryk’s order is a nationwide stay of the drug’s approval, while Judge Rice’s order to maintain the status quo availability only applies to the specific plaintiffs.  Notably absent from the Washington order’s applicability would be California, Massachusetts, New Jersey, New York, North Carolina, New Hampshire, and Virginia.Continue Reading Mifepristone Cases – Our Thoughts