Planned Parenthood Grateful For Efforts To Protect Access To Abortion Medication

Representatives from Planned Parenthood of Southern New England said Tuesday they are grateful for efforts by Connecticut Attorney General William Tong and AGs from 16 other states and Washington, D.C. to protect patients’ access to mifepristone, an abortion medication.

In a motion for summary judgement filed last week in a federal court in Washington state, the 18 AGs want the court to order the US Food and Drug Administration to come up with new regulations for mifepristone as the current restrictions, they say, make the drug less accessible to patients despite evidence that it’s safer than Tylenol.

In a statement issued Tuesday, Planned Parenthood of Southern New England thanked the coalition of AGs for their work.

“The evidence and research is clear; mifepristone is a safe and effective medication that has expanded abortion access and helped ensure patients are able to make their own private medical decisions – something that is under dire threat in this country,” the statement reads.

Tong said last week that the coalition wants the matter remanded back to the FDA to come up with new rules “based on science and safety.”

Representatives for the FDA declined to comment citing the pending litigation.

In the motion, the coalition argues that Congress authorized the FDA to impose special restrictions only if it is to ensure safety.

“The record also shows that FDA failed to consider its restrictions’ impact on patient access, violating Congress’s express directive,” according to the motion. “This Court should again hold that FDA violated the law in imposing special restrictions on mifepristone, and should remand this matter to FDA for proper consideration of the statutory requirements and record evidence.”

According to the FDA’s website, mifepristone blocks a hormone called progesterone which is needed for a pregnancy to continue. The drug is usually taken with misoprostol for first-trimester abortion. Mifepristone was first approved in September 2000 through 7 weeks gestation, which was extended to 10 weeks in 2016, according to the website. 

According to last week’s motion, a 2016 medical review by the FDA was based on 2.5 million uses of the drug in the country, and concluded it was safe based on research and experience with rare instances of complications. 

“Mifepristone is also far safer than a pregnant person’s alternative to abortion: giving birth, where the risk of death is ’14 times higher’ than with abortion, and which is far riskier to health,” according to the motion. 

Mifepristone is an FDA-approved drug that has extra restrictions known as a Risk Evaluation and Mitigation Strategy (REMS). Of 20,000 approved prescription drugs, there are only 73 REMS, according to the motion, which also notes that mifepristone is safer than common drugs like Viagra, and penicillin – none of which have a REMS.

The American College of Obstetricians and Gynecologists (ACOG), American Academy of Family Physicians, and American Medical Association (AMA), have opposed the REMS because they are both “scientifcally unfounded” and “harmful to patients because it interferes with evidence-based care and causes treatment delays “without supporting demonstrated improvements to patient safety or outcomes,” according to the motion.

The FDA approved the current mifepristone REMS in January 2023, including: prescriber certification, pharmacy certification, and a patient agreement form. 

“As the administrative record shows, the REMS creates stigma, fear, and reluctance to prescribe a safe and essential medication, artificially limits the number of providers who can prescribe mifepristone and the number of pharmacies that can dispense it, endangers providers’ and patients’ safety, and negatively impacts access to and quality of care,” the motion states.

In April 2023, the federal judge in Washington state, Thomas O. Rice, granted the coalition’s request for a preliminary injunction, which kept the FDA from doing anything that would reduce the availability of mifepristone in the 17 states and D.C.
According to a 2023 opinion drafted by Tong, mifepristone remains FDA-approved in Connecticut under the 2023 REMS.