Intervenors/Defendants - Appellants and JOSHUA H. STEIN, in his official capacity as Attorney General for the State of North Carolina; JEFF NIEMAN, in his official capacity as District Attorney for North Carolina 18th Prosecutorial District; KODY H. KINSLEY, in his official capacity as the North Carolina Secretary of Health and Human Services;

DO, in her official capacity as a member of the North Carolina Medical Board; DEVDUTTA G. SANGVAI, M.D., MBA, in his official capacity as a member of the North Carolina Medical Board; JOHN W. RUSHER, M.D., JD, in his official capacity as a member of the North Carolina Medical Board; WILLIAM M. BRAWLEY, in his official capacity as a member of the North Carolina Medical Board; W. HOWARD HALL, M.D., in his official capacity as a member of the North Carolina Medical Board; SHARONA Y. JOHNSON, PHD, FNP-BC; JOSHUA D. MALCOLM, JD, in his official capacity as a member of the North Carolina Medical Board; MIGUEL A. PINEIRO, PA-C, MHPE, in his official capacity as a member of the North Carolina Medical Board; MELINDA H. PRIVETTE, M.D., JD, in her official capacity as a member of the North Carolina Medical Board; ANURADHA RAO-PATEL, M.D., in her official capacity as a member of the North Carolina Medical Board; ROBERT RICH, JR., M.D., in his

USCA4 Appeal: 24-1576 Doc: 60 Filed: 10/25/2024 Pg: 2 of 4 official capacity as a member of the North Carolina Medical Board Defendants - Appellees

USCA4 Appeal: 24-1576 Doc: 60 Filed: 10/25/2024 Pg: 4 of 4 Maine, State of Maryland, State of Michigan, State of Minnesota, State of New Jersey, State of New York, State of Oregon, State of Pennsylvania, State of Rhode Island, State of Vermont, and the State of Washington have filed an amicus curiae brief.

The court accepts the brief for filing.

Intervenors/Defendants - Appellants and JOSHUA H. STEIN, in his official capacity as Attorney General for the State of North Carolina; JEFF NIEMAN, in his official capacity as District Attorney for North Carolina 18th Prosecutorial District; KODY H. KINSLEY, in his official capacity as the North Carolina Secretary of Health and Human Services;

DO, in her official capacity as a member of the North Carolina Medical Board; DEVDUTTA G. SANGVAI, M.D., MBA, in his official capacity as a member of the North Carolina Medical Board; JOHN W. RUSHER, M.D., JD, in his official capacity as a member of the North Carolina Medical Board; WILLIAM M. BRAWLEY, in his official capacity as a member of the North Carolina Medical Board; W. HOWARD HALL, M.D., in his official capacity as a member of the North Carolina Medical Board; SHARONA Y. JOHNSON, PHD, FNP-BC; JOSHUA D. MALCOLM, JD, in his official capacity as a member of the North Carolina Medical Board; MIGUEL A. PINEIRO, PA-C, MHPE, in his official capacity as a member of the North Carolina Medical Board; MELINDA H. PRIVETTE, M.D., JD, in her official capacity as a member of the North Carolina Medical Board; ANURADHA RAO-PATEL, M.D., in her official capacity as a member of the North Carolina Medical Board; ROBERT RICH, JR., M.D., in his

USCA4 Appeal: 24-1576 Doc: 4 Filed: 07/02/2024 Pg: 2 of 3 official capacity as a member of the North Carolina Medical Board Defendants

Intervenors/Defendants - Appellees and JOSHUA STEIN, in his official capacity as Attorney General for the State of North Carolina; JEFF NIEMAN, in his official capacity as District Attorney for North Carolina 18th Prosecutorial District; KODY H. KINSLEY, in his official capacity as the North Carolina Secretary of Health and Human Services; PHD MICHAUX R. KILPATRIC, M.D.

; DO CHRISTINE M. KHANDELWAL, in her official capacity as a member of the North Carolina Medical Board; MBA DEVDUTTA G. SANGVAI, M.D., in his official capacity as a member of the North Carolina Medical Board; JD JOHN W. RUSHER, M.D., in his official capacity as a member of the North Carolina Medical Board; WILLIAM M. BRAWLEY, in his official capacity as a member of the North Carolina Medical Board; W. HOWARD HALL, M.D., in his official capacity as a member of the North Carolina Medical Board; PHD, FNP-BC SHARONA Y. JOHNSON; JD JOSHUA D. MALCOLM, in his official capacity as a member of the North Carolina Medical Boad; PA-C, MHPE MIGUEL A. PINIERO, in his official capacity as a member of the North Carolina Medical Board; JD MELINDA H. PRIVETTE, M.D., in her official capacity as a member of the North Carolina Medical Board; ANURADHA RAO-PATEL, in her official capacity as a member of the North Carolina Medical Board; ROBERT RICH, JR., M.D., in his official capacity as a member of the North Carolina Medical Board

She simply contends that states cannot impose restrictions on a REMS drug that FDA considered and rejected and that interfere with FDA’s efforts to facilitate patient access.2 Parties in litigation should deal with their opponents’ arguments forthrightly, and intervenors’ refusal to do so speaks to the weakness of their position.

And, like in Geier and unlike in Williamson, the record here leaves no doubt that FDA “thought it important” to free patients and providers from the restrictions at issue and give them “a choice” between meeting with a REMS-certified prescriber in person or via telemedicine and USCA4 Appeal: 24-1576 Doc: 67 Filed: 12/18/2024 Pg: 15 of 38

Intervenors also argue (at 18–19) that Congress prohibited FDA from regulating “the practice of medicine.” But the statute they rely on says only that the FDCA shall not be construed to interfere with a healthcare practitioner’s “authority … to prescribe or administer any legally marketed device,” which is not at issue here.

Intervenors say (at 2, 34) that preemption of North Carolina’s in- person informed-consent requirement depends on “tortured logic” and “vague ‘notions’ of agency intent,” but there is nothing vague about it: FDA expressly determined that “[a] certified prescriber can … review the USCA4 Appeal: 24-1576 Doc: 67 Filed: 12/18/2024 Pg: 22 of 38

As Dr. Bryant explained, Wyeth supports that claim because the Court went out of its way to emphasize that “FDA did not consider and reject” the state-law requirement at issue there and to leave open the possibility that state law could have been preempted if FDA had done so.

Counsel for Intervenors/Defendants- Appellants Timothy K. Moore and Philip E. Berger, Plaintiff-Appellee Amy Bryant, M.D., Defendant-Appellee Joshua H. Stein, and Defendant-Appellees Sharona Y. Johnson, Michaux R. Kilpatrick, and members of the North Carolina Medical Board consent to amici’s filing.

Amici believe that all patients are entitled to treatment that is medically and scientifically sound, including access to drugs that have undergone the FDA’s rigorous approval process.

USCA4 Appeal: 24-1576 Doc: 50-1 Filed: 10/17/2024 Pg: 4 of 8 Additionally, amici have a strong interest in ensuring that legal decisions are based on sound, scientifically-backed evidence.

In of support Plaintiff-Appellee’s arguments, amici seek to file this brief to provide a medical perspective on the issues in this case, with a specific focus on the real-world practice of medicine, and to demonstrate the patient harms that will occur should this Court reverse the judgment of the district court insofar as it held that North Carolina’s restrictions governing medical abortion are preempted by federal law or uphold the judgment of the district court insofar as it held that North Carolina’s restrictions governing medical abortion are not preempted by federal law.

The proposed brief will aid the Court both by providing the perspective of a wide range of medical professionals with real world experience prescribing and administering USCA4 Appeal: 24-1576 Doc: 50-1 Filed: 10/17/2024 Pg: 5 of 8 mifepristone and by bringing peer-reviewed studies demonstrating mifepristone’s safety and efficacy to the Court’s attention.

Intervenors next argue (at 23–25) that “FDAAA’s structure and context confirm that Congress did not intend to broadly preempt state law.” But none of the evidence they cite suggests Congress did not want ordinary, background ...

Intervenors nonetheless claim (at 23) that FDAAA’s only purpose was “to increase drug regulation,” ignoring Congress’s express commands to FDA to minimize burdens on patient access and the healthcare system.

The district court nonetheless held that these requirements escape preemption because they are “unrelated to mifepristone.” JA633.