Does the abortion medication mifepristone remain legal and accessible in Connecticut?

Plain-English summary

Governor Ned Lamont asked the Connecticut Attorney General whether mifepristone, the first drug in the two-medication regimen used for medication abortion and miscarriage care, remained legal and accessible in Connecticut following a wave of April 2023 federal court rulings. The Attorney General concluded that it did. A Texas federal judge had preliminarily ordered the FDA to stay its approval of mifepristone in Alliance for Hippocratic Medicine v. FDA, but the opinion explained that ruling was not binding on Connecticut. Instead, a separate order in Washington v. FDA, obtained by Connecticut and sixteen other states plus the District of Columbia, required the FDA to maintain the pre-litigation status quo for mifepristone in those states, including Connecticut, "irrespective" of the Texas case or the Fifth Circuit's related ruling.

Because the Washington v. FDA order controlled, the opinion concluded the FDA had to keep mifepristone's approval, dosage, prescribing authority, and dispensing rules in Connecticut exactly as they existed under the January 2023 Risk Evaluation and Mitigation Strategy (REMS): both branded and generic mifepristone remained approved, for use through ten weeks' gestation, dispensable without a mandatory in-person visit, prescribable by qualifying non-physician providers, and dispensable through certified pharmacies, at the existing 200 mg dose.

What this means for you

Medicaid (HUSKY) administrators: The opinion states that Connecticut must continue to cover mifepristone prescriptions for HUSKY beneficiaries, citing Doe v. Maher for the proposition that the state constitution requires HUSKY to cover medically necessary abortions, and Regs. Conn. State Agencies § 17b-262348(r)(3) for the Department of Social Services' obligation to cover abortions a provider deems medically necessary.

Health care providers: The opinion states that prescribing mifepristone under the January 2023 REMS, consistent with the Department of Public Health's March 2023 abortion policies and procedures, is not by itself "illegal conduct" that exposes a provider to state discipline. The opinion notes this does not shield a provider from discipline for other sanctionable conduct, such as negligence or incompetence.

Pharmacies and patients: The opinion states that mifepristone's approved dosage, the ten-week gestation window, the lack of a mandatory in-person visit requirement, and pharmacy dispensing authority all remained in effect in Connecticut under the Washington v. FDA order, unaffected by the Texas ruling.

Common questions

Q: Did the Texas federal court ruling against the FDA make mifepristone illegal in Connecticut? A: No. The opinion concluded that the Texas ruling in Alliance for Hippocratic Medicine v. FDA was not binding on Connecticut, and that a separate order in Washington v. FDA controlled mifepristone's status in the state.

Q: Will Connecticut's Medicaid program (HUSKY) still pay for mifepristone? A: The opinion states yes, citing Doe v. Maher and Regs. Conn. State Agencies § 17b-262348(r)(3) as requiring HUSKY to cover medically necessary abortions, including medication abortion.

Q: Can a Connecticut health care provider be disciplined by the state for prescribing mifepristone? A: The opinion states that prescribing mifepristone consistent with the January 2023 REMS and the Department of Public Health's abortion policies is not, by itself, grounds for state discipline, though other sanctionable conduct remains subject to discipline.

Q: Did this opinion change the dosage or gestational limit for mifepristone in Connecticut? A: No. The opinion describes the existing rules, an approved dose of 200 mg and use through ten weeks' gestation, as staying in effect under the Washington v. FDA order.

Source

• Landing page: https://portal.ct.gov/AG/Opinions
• Original PDF: https://portal.ct.gov/-/media/ag/opinions/2023/2023-03_formal_opinion_on_mifepristone_access_in_connecticut.pdf?rev=5c034fd24feb4ef0a8f817959d806819

Original opinion text

April 14, 2023
The Honorable Governor Ned Lamont
Office of the Governor
State Capitol
210 Capitol Avenue
Hartford, CT 06106
Re:

Formal Opinion on Mifepristone Access in Connecticut

Dear Governor Lamont:
In response to your request, my opinion is that the Food and Drug Administration (FDA) approval of both branded and generic mifepristone remains in full force and effect in Connecticut under the status quo prior to this month's federal court orders. The FDA first approved mifepristone in 2000. Followed by misoprostol in a twomedication regimen, mifepristone is the gold standard for medication abortion and miscarriage care, used safely and effectively by 5.6 million patients to date. Over the years, the FDA modified its requirements for using, prescribing, and dispensing mifepristone as it received and reviewed new data. The most recent set of requirements, issued in January 2023, are known as the "2023 REMS," short for "Risk Evaluation and Mitigation Strategy." On April 7, 2023, a federal judge in Texas issued a preliminary order commanding the FDA to "stay" its 23-year-old approval of mifepristone. Our office strongly disagrees with that order – issued in Alliance for Hippocratic Medicine v. FDA, No. 22-223 (N.D. Tex.) ("AHM") – on procedure, substantive law, and underlying science. The U.S. Court of Appeals for the Fifth Circuit has put a critical element of the preliminary order on hold, and the FDA has asked the Supreme Court to prevent any aspect of the order from taking effect pending appeal. We supported that request with a friend-of-the-court brief, and we look forward to the preliminary order's complete reversal. But regardless of the appeals process: Neither the AHM preliminary order nor the Fifth Circuit ruling is binding in, or on, the state of Connecticut. 165 Capitol Avenue Hartford, Connecticut 06106 An Affirmative Action/Equal Opportunity Employer

Governor Ned Lamont
April 14, 2023
Page | 2

Instead, a separate federal court order – also issued on April 7, and reiterated on April 13
– forbids the FDA from "altering the status quo and rights as it relates to the availability of mifepristone" in Connecticut. Order Granting Motion for Clarification and Motion to Expedite, Washington v. FDA, No. 23-3026 (E.D. Wash. Apr. 13, 2023). In that case, Washington v. FDA, Connecticut partnered with 16 other states and the District of Columbia in suing the FDA to promote and ensure access to mifepristone. We won a federal court order from Judge Thomas Rice compelling the FDA to maintain the mifepristone status quo under the 2023 REMS. Judge Rice's order took effect before the AHM preliminary order and specifically applies to Connecticut "irrespective" of the Texas proceeding or the Fifth Circuit's order. Because Judge Rice's injunction controls here, the FDA must maintain mifepristone's approval in Connecticut under the pre-litigation status quo. That means, among other things, that the FDA must:

Maintain approval of branded and generic mifepristone;
Maintain authorization of mifepristone for use through ten weeks' gestation; Maintain authorization to dispense mifepristone without any mandatory in-person visit; Maintain authorization for health care providers, including some non-physicians, to prescribe and administer mifepristone subject to the January 2023 REMS; Omit any requirement that non-fatal adverse events be reported; Maintain authorization for certified pharmacies to dispense mifepristone subject to the January 2023 REMS; Maintain the dosage of mifepristone at 200 mg.

I specifically highlight two important implications of my opinion that mifepristone remains FDA-approved in Connecticut under the 2023 REMS. First: Connecticut must continue to cover mifepristone prescriptions for beneficiaries of HUSKY, our Medicaid program. That obligation comes from both caselaw and state regulations. See Doe v. Maher, 40 Conn. Supp. 394 (1986) (holding that the state constitution requires HUSKY to cover medically necessary abortions); Regs. Conn. State Agencies § 17b-262348(r)(3) (requiring the Department of Social Services to cover all abortions deemed medically necessary by a provider). Second: The State has no basis to take disciplinary action against a health care provider simply for prescribing mifepristone, if the provider may prescribe mifepristone under the 2023

Governor Ned Lamont
April 14, 2023
Page | 3

REMS and complies with the Department of Public Health's March 2023 abortion policies and procedures. Prescription of mifepristone, by itself, is not "illegal conduct" exposing a provider to discipline. Of course, nothing in this letter prevents or protects against discipline for any otherwise sanctionable conduct, including negligence and incompetence. The Attorney General's Office is deeply engaged in ongoing litigation over abortion rights and reproductive justice. We will promptly issue further opinions, guidance, and communication to reflect any further developments. Very truly yours,

WILLIAM TONG