CONFLICTING COURT RULINGS PUT FUTURE ACCESS TO ABORTION MEDICATIONS AT RISK NATIONWIDE

By Daniela Torres

Image by Yuchaxz, cc 4.0 via Wikimedia Commons

April 13, 2023 (San Diego) -- U.S. District Judge Matthew Kacsmaryk in Texas has ruled to suspend the approval of mifepristone, a medication that has on the market for over two decades. But Thomas O. Rice, a federal judge from the state of Washington, has issued an opposite ruling, ordering that no changes be made that would restrict mifepristone. The conflicting rulings leave women and medical providers in limbo, with appeals to higher courts in the works to resolve the conflicting decisions.

The Texas ruling came in the lawsuit Alliance for Hippocratic Medicine v. FDA. The plaintiff’s complaint argued that the “FDA's approval and subsequent regulation of medication abortion was in excess of the agency's jurisdiction as well as arbitrary and capricious.”

The plaintiffs are conservative, pro-life organizations and physicians: Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians and Gynecologists, American College of Pediatricians, and Christian Medical & Dental Associations, Shaun Jester, D.O., Regina Frostclark, M.D., Tyler Johnson, D.O., and Geroge Delgado M.D..

A preliminary injunction was issued on April 7, after Kacsmaryk released his 67-page ruling. The injunction he ordered would take place seven days later to allow the federal government and U.S Food Drug and Administration (FDA) seven days to appeal.

The Department of Justice issued a statement from Attorney General Merrick B. Garland on April 7, which states that the department “strongly disagrees” with the decision made by Kacsmaryk and that they will be “appealing the court’s decision and seeking a stay pending appeal.”

Danco Laboratories is one of the pill manufacturers who makes mifepristone. The distributor requested that the U.S. Court of Appeals for the 5th Circuit to maintain the current approval on the medication.

The government stated that the court’s order would “thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity.” In addition, they state that the plaintiffs have no evidence backing up their claims that mifepristone harms those who take it.

President Biden and Vice President Harris have both released statements regarding the matter. The Biden administration will fight the ruling and continue “to fight to protect a woman’s right to an abortion”, says Biden in his statement.

U.S. Court of Appeals for the 5th Circuit, which has been said to be the country’s most conservative appeals court, has put on hold Kacsmaryk’s ruling to withdraw the approval of the medication. There is also still a possibility that the distribution of mifepristone through mail could be suspended. The Supreme Court may end up getting involved, which currently has a 6-3 conservative majority.

In Washington, Judge Thomas O. Rice has ruled that mifepristone must remain available and that no changes be made that would restrict individuals from obtaining and using the medication. Rice’s ruling could also be appealed and blocked by the courts.

What is Mifepristone?

Mifepristone blocks a hormone called progesterone and prevents a pregnancy from growing. It is typically taken alongside a second medication - misoprostal. Misoprostal can be taken right away or up to 48 hours after taking mifepristone. It causes the uterus to empty in order to expel the pregnancy.

Planned Parenthood states its effectiveness for both medications at:

• For people who are 8 weeks pregnant or less, it works about 94-98 out of 100 times.
• For people who are 8-9 weeks pregnant, it works about 94-96 out of 100 times
• For people who are 9-10 weeks pregnant, it works about 91-93 out of 100 times. If you're given an extra dose of medicine, it works about 99 out of 100 times.
• For people who are 10-11 weeks pregnant, it works about 87 out of 100 times. If you're given an extra dose of medicine, it works about 98 out of 100 times

There are less side effects when mifepristone is used alongside misoprostal; however, it is less effective on its own.

The FDA first approved Mifeprex in September of 2000. The generic version, mifepristone tablets, were approved in April of 2019. According to the occasional periodic reviews conducted, the FDA has not identified any dangers associated with taking the medication before the 10-week period.

The approved dosing regimen is 200 mg of mifepristone followed by 800mcg of misopristal.

There have been 28 reports of deaths in patients as of June 30, 2022, but the FDA cannot attribute them due to “concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient”. The FDA has declared that mifepristone is safe when used as indicated.

In comparison to the abortion pill, it is estimated that “30 women die for every 100,000 unsafe abortions.”

What happens next?

As for what health providers plan to do if mifepristone is withdrawn, misoprostal-only abortions will continue to be given in states such as California, where this is legal. Planned Parenthood’s press release stated that their health centers would continue to do “whatever is possible to provide patients with timely abortion care, including the method that is best for their circumstances.”

Advocates for abortion are strongly speaking out against Kacsymaryk’s decision. The Center for Reproductive Rights considers this ruling a “devastating blow to abortion access” across the country. If the Supreme Court is to uphold the Kacymaryk’s decision, mifepristone would be made illegal in all states. States that are renowned for providing individuals with reproductive rights and care would no longer be able to utilize mifepristone.

Abortion has already been banned or restricted in 17 states following the overturn of Roe v. Wade in June of 2022.

If the Supreme Court allows the Texas ruling forcing the FDA to withdraw its decades-old approval of mifepristone, the ruling could also lead to other drugs being scrutinized and possibly having their approvals withdrawn.

More than 500 pharmaceutical industry representatives have signed a letter warning that  if a court is able to make decisions on whether or not a drug is safe, rather than the FDA making science-based decisions, vaccines and other medications that are used daily by millions of Americans could be deemed unsafe by a single judge and no longer be accessible. Adding regulatory uncertainty would also likely reduce incentives for investment in new medications, endangering innovation, the industry executives concluded.