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.
The bill, one of four appropriations bills that is being considered in a marathon session by the House of Representatives as the close of the federal fiscal year approaches, contains the following provision:
(a) The modifications made by the Food and Drug Administration on January 3, 2023 to the risk evaluation and mitigation strategy under section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) for mifepristone are hereby nullified.
(b) None of the funds made available by this Act may be used to establish, implement, or enforce—
(1) any provision of a risk evaluation and mitigation strategy under section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) for mifepristone that is substantially similar to any of the modifications nullified by subsection (a); or
(2) any non-enforcement or enforcement discretion policy for any provision of a risk evaluation and mitigation strategy under such section for mifepristone.
Bill passage is unlikely
The atmosphere surrounding the government funding bills is so unsettled that it is not clear whether this act will pass the House. The House of Representatives is split, not just along party lines, but also within the Republican majority in determining whether they will approve any of the appropriations bills.
The federal fiscal year ends on September 30. Both houses of Congress have been scrambling this week to pass either the necessary appropriations or a Continuing Resolution to allow the federal government to remain funded pending final appropriations bill passage. The House of Representatives began debating the bills in the evening of September 26 beginning with the text and amendments to the Agricultural and FDA appropriations bill which includes the mifepristone language.
The consideration of that bill lasted until the early morning hours of September 27. Upon reconvening, the GOP-controlled House began to debate and amend the other three appropriations bills, governing the Departments of Defense, Homeland Security, and State. As of publication, the bills are still under consideration but are expected to get voted on late in the evening. If they do eventually pass by the end of the week, they will then have to pass a closely divided Senate where Democrats have a majority. Because Democrats generally support the ability of retail pharmacies to dispense mifepristone, it is unlikely that Section 761 of the Agriculture and FDA bill would survive that chamber. Even if the bill manages to pass both chambers, it is unlikely that President Biden would sign a law that included that provision.
Continuing Resolution a possibility
At the same time, the Senate is considering a continuing resolution that would allow the government to stay open beyond the end of fiscal year. On September 26, the Senate voted for cloture on a vehicle for a continuing resolution 77-19. The Senate is scheduled to take up the resolution on September 28.
That resolution has bipartisan support in the Senate and, should it pass, may have a chance to pass the House as well. That does not mean that the House appropriations bills would fail, instead it would give both houses of Congress more time to make changes to those bills.
Additionally, any continuing resolution that passes the Senate would have to pass through the House as well, where the same members could attempt to include Section 761 into that bill instead of the appropriations bill.
REMS is subject to Supreme Court review
The REMS for mifepristone is currently the subject of a pair of petitions to the U.S. Supreme Court challenging a decision by the U.S. Court of Appeals for the Fifth Circuit which effectively would force FDA to rescind the January 2023 change to the REMS that allowed pharmacies to dispense mifepristone. The original FDA approval of the drug is also under review in this case as that was the subject of the district court action.
Placement of this policy priority into a must-pass piece of legislation like an appropriations bill at the end of the fiscal year is not an unexpected tactic. There are a number of other must-pass pieces of legislation that will come up in the next 12 months, including the 2023 Farm Bill and any extension of the debt limit beyond its current end of January 2025. So it is possible that, even if this attempt fails, it could be reinserted into a later piece of legislation.
Reed Smith will continue to track both legislative and judicial developments regarding the regulation of mifepristone. If you have a question about this, please feel free to reach out to the health care lawyers at Reed Smith.