United States Court of Appeals

State of Texas v. Becerra USDC No. 5:22-CV-185

The court has granted in part an extension of time, to and including August 4, 2023, for filing a reply brief in this case.

United States Court of Appeals

State of Texas v. Becerra USDC No. 5:22-CV-185

The court has granted an extension of time to and including June 30, 2023 for filing appellee’s/respondent’s brief in this case.

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.

Supreme Court of the United States No.

UPON FURTHER CONSIDERATION of the application of counsel for

the applicant, the response, and the reply filed thereto,

IT IS ORDERED that the stay issued on April 14, 2023, is hereby extended until 11:59 p.m. (EDT) on Friday, April 21, 2023.

Associate Justice of the Supreme Court of the United States

... federal-state cooperation on matters of drug safety and explained that “federal preemption is particularly weak where Congress has indicated its awareness of the operation of state law in a field of federal interest and has nonetheless ...

Because none of the challenged laws make mifepristone less safe, they do not pose an “actual conflict” with the FDAAA and are not preempted.

A reversal of the district court’s decision would set a precarious precedent permitting and encouraging individual states to enact a patchwork of restrictions on pharmaceutical products for which the U.S. Food and Drug Administration (FDA) has determined additional controls are necessary to protect patient safety.

Congress expanded FDA’s authority in 2007 to encompass drugs with important benefits that, due to their safety risks, would otherwise be unavailable but for an FDA-approved REMS, which can include specific controls called Elements to Assure Safe Use (ETASU).

FDA takes this mandate seriously and has emphasized the importance of “[a]ssessing the impact of REMS on patient access to the drug and its burden on the healthcare delivery system,” where “burden reflects the additional effort that USCA4 Appeal: 24-1576 Doc: 49 Filed: 10/17/2024 Pg: 45 of 56

development program to compensate for uncertainty regarding the scope of present and future state regulatory requirements), but also would also be unfair to the extent that, as in the case of the North Carolina medication abortion laws, FDA has already considered and rejected the restrictions imposed.

Further, a significant proportion of drug innovation is conducted by smaller biotechnology and pharmaceutical companies, such as amici, which lack the funding and resources to devote to the burdensome task of tracking and ensuring compliance with state-by-state restrictions.

Follow-up examinations of all 57 participants reflected no sensitization, and none of the women experienced any Rh sensitization impacts during the 11 Rh-positive pregnancies that occurred after.

Dear Clerk: The Court today entered the following order in the above-entitled case: The petition for a writ of certiorari is denied.

Sincerely, full &.

Yoo Scott S. Harris, Clerk

Before the Court is the American College of Obstetricians and Gynecologists’s and the Society for Maternal-Fetal Medicine’s (“Amici”) Application for Admission Pro Hac Vice (“Application”) (ECF No. 80), filed March 12, 2025.

James C. Martin represents that he has read—and will comply with—both Dondi Props.

1988) and the Local Rules for the Northern District of Texas.

And the Court has waived the local counsel requirement of Local Rule 83.10 for Amici.

Thus, the Application is GRANTED.

Before the Court is the American College of Obstetricians and Gynecologists’s and the Society for Maternal-Fetal Medicine’s (“Amici”) Application for Admission Pro Hac Vice (“Application”) (ECF No. 95), filed March 18, 2025.

Vicki J. Tankle represents that she has read—and will comply with—both Dondi Props.

1988) and the Local Rules for the Northern District of Texas.

And the Court has waived the local counsel requirement of Local Rule 83.10 for Amici.

Thus, the Application is GRANTED.

Before the Court is the American College of Obstetricians and Gynecologists’s and the Society for Maternal-Fetal Medicine’s (“Amici”) Application for Admission Pro Hac Vice (“Application’’) (ECF No. 83), filed March 12, 2025.

Arielle R. Lusardi represents that she has read—and will comply with—both Dondi Props.

1988) and the Local Rules for the Northern District of Texas.

And the Court has waived the local counsel requirement of Local Rule 83.10 for Amici.

Thus, the Application is GRANTED.

Before the Court is the American College of Obstetricians and Gynecologists’s and the Society for Maternal-Fetal Medicine’s (“Amici”) Application for Admission Pro Hac Vice (“Application”) (ECF No. 90), filed March 13, 2025.

Kristin B. Parker represents that she has read—and will comply with—both Dondi Props.

Savs.

1988) and the Local Rules for the Northern District of Texas.

And the Court has waived the local counsel requirement of Local Rule 83.10 for Amici.

In civil, agency, bankruptcy, and mandamus cases, a disclosure statement must be filed by all parties, with the following exceptions: (1) the United States is not required to file a disclosure statement; (2) an indigent party is not required to file a disclosure statement; and (3) a state or local government is not required to file a disclosure statement in pro se cases.

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No. __________ Caption: __________________________________ Amy Bryant v. Timothy Moore Pursuant to FRAP 26.1 and Local Rule 26.1,

(amici curiae do not complete this question) ✔ If yes, identify any publicly held member whose stock or equity value could be affected substantially by the outcome of the proceeding or whose claims the trade association is pursuing in a representative capacity, or state that there is no such member:

✔ If yes, the United States, absent good cause shown, must list (1) each organizational victim of the criminal activity and (2) if an organizational victim is a corporation, the parent corporation and any publicly held corporation that owns 10% or more of the stock of victim, to the extent that information can be obtained through due diligence.

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s/ Julia C. Payne July 7, 2024 Reset Form Print for PDF for Filing