Abortion Laws : Ohio and Federal: Agency Guidance (Abortion Pills)

Politico 11/23/22

12/16/21 FDA.gov. Medical abortion drug mifepristone will be available by mail order prescription permanently.

The FDA warned Aidaccess.org in 2019 about providing mifepristone through the mail, but hasn't done anything about it.

VOX 5/7/22 Aidaccess.org sued the FDA over it's warning letter. The FDA has not brought further action against Aidaccess.

When FDA thinks that a manufacturer violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation. . The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate.

Makes mailing any article or thing designed, adapted, or intended for producing abortion illegal. The Comstock Law was passed in 1873, before women had the right to vote. The part of the Comstock Law applying to birth control was repealed in 1971, but the abortion language remains.

4/7/23 US Dist. Ct, Northern Dist of Texas enjoined use of abortion pill nationwide, but gave federal gov't 7 days to appeal.

The US Supreme Court granted cert in this case. Oral argument is on March 26, 2024. It will be decided in 2024.

The Supreme Court grants cert on whether the pandemic rules for sending mifepristone through the mail were arbitrary, but denies cert on whether the FDA's original approval of abortion pill was arbitrary.

Ohio Capital Journal 5/10/23

Law Dork 11/6/23

4/24/23 Ohio Capital Journal. Alliance for Hippocratic Medicine v. FDA will play out in the 5th Cir. Ct. of Appeals.

4/7/23 Federal district court said that abortion pills could not be enjoined nationwide.

4/12/23

HHS.gov 7/11/22

Texas sues to prevent HHS' guidance on emergency medical care including abortion from going into effect. 7/14/22

8/24/22

Veterans' Affairs' website 9/2/22

Aid Access is the private initiative of Dutch doctor, Rebecca Gomperts. The purpose of the website and the service is to help women who do not have the possibility of accessing local abortion services.

Ideastream 3/1/24

FDA.gov 1/3/23. Permanently revokes in person prescribing requirement and allows retail pharmacies to fill prescriptions for mifepristone, if it is legal in the state and if the pharmacy becomes certified and follows stringent reporting obligations.

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

Only certified pharmacies can carry mifepristone because of the REMS

The American College of Obstetricians and Gynecologists (ACOG) has long opposed the REMS for mifepristone. Decades of evidence and the consensus of the medical community underscore that mifepristone is a safe medication.

2/1/23