WASHINGTON – The Supreme Court will likely act on Wednesday in response to a federal government request to block an immediate ruling by a lower court that could threaten access to the abortion pill mifepristone.
Both the Food and Drug Administration and Danco Laboratories (which makes Mifeprex brand mifepristone) are seeking to put on pause a decision last week made by the 5th U.S. Circuit Court of Appeals would suspend several regulatory actions that were taken since 2016 to make it easier for women to access the drug.
The Supreme Court has a conservative majority of 6-3 and temporarily blocked the appeals courts decision on F riday, while it considers the next steps. The Supreme Court is expected to take action by midnight on Wednesday.
The Biden administration will need at least five votes from the nine justices of the Supreme Court, who voted 5-4 in the summer of last year to overturn Roe v. Wade, the landmark ruling that said women across the country have the right of abortion.
The new case will raise different legal questions about the FDA process for approving drug, but it’ll still test last year’s promise that the court would leave abortion policy up to the states and federal government.
The appeals court narrowed the scope a bit of a ruling that was issued by U.S. District Judge Matthew Kacsmaryk. The 5th Circuit did not suspend FDA approval for mifepristone, in 2000, like Kacsmaryk ruled. This would have made its distribution illegal.
The appeals court, however, allowed certain elements of Kacsmaryk’s decision to be in effect. If these parts are implemented, the FDA decision from 2021 that allowed mifepristone distribution by mail will be suspended. The same goes for the 2019 decision which approved a generic mifepristone made by GenBioPro.
The FDA made changes in 2016 that reduced the required number of visits to patients from three to just one, and permitted the prescription of the pill to women with a gestation of up to 10 weeks instead of seven.
The appeals court ruled that the coalition of anti-abortion groups who brought the lawsuit waited too long before contesting the approval from 2000 in court. The court found that claims could be brought against the 2016 revisions as well as later decisions. The court also determined that the Comstock Act of 19th century, which prohibited the mailing of any medicine or drug that could be used to induce abortion, was a factor in its analysis of 2021’s decision to allow the distribution of mifepristone by mail.
In a separate case, a federal judge in Washington State added another wrinkle to the story by issuing an injunction that bars the FDA from changing the status quo or rights in relation to the availability of the drug mifepristone.
This ruling, issued on April 7, only applies to 17 liberal states, Washington, D.C., and the District of Columbia, who sued the FDA in February, challenging its regulations regarding the drug.
The pharmaceutical industry has been critical of both rulings. The trade group PhRMA stated in a brief to the Supreme Court that the Kacsmaryk ruling would upset the “settled framework” and investments that depend on it if it were applied to other drugs.
Kacsmaryk’s ruling was the first since the FDA was created almost a century ago in which “any court had nullified an FDA approval by second-guessing a safety-and-effectiveness determination,” the brief said.
According to a Guttmacher Institute research group, the majority of abortions are performed in the U.S. using pills.
Due to the Supreme Court decision to overturn Roe V. Wade, several conservative states have passed strict abortion restrictions, making it hard if not impossible to end a pregnancy. This is true whether women use pills or undergo a surgical procedure. Guttmacher reports that abortion is banned in 12 states.