The abortion pill case is poking the FDA. Is the agency bruised?

The Supreme Court ruled to keep mifepristone's approval intact as litigation seeking to revoke the FDA-approved abortion pill continues to play out in lower courts. 

On April 21, the Supreme Court issued a stay to keep mifepristone widely available with an unsigned, one-paragraph order. Justices Clarence Thomas and Samuel Alito Jr. dissentend.

How the legal case played out

In November, four organizations and four physicians filed suit against the FDA over its 2000 approval of mifepristone, arguing the drug is not safe and the agency did not have the right to approve it. A Texas federal  judge then ruled in April to suspend the approval, effective April 14. 

The FDA appealed the federal judge's decision, moving the case to the 5th U.S. Circuit Court of Appeals. The appeals court partially overturned the former ruling on April 12, stating the statute of limitations bars the judiciary branch from pulling an FDA-approved product. However, the appeals court ruled against the FDA's 2016 amendment to mifepristone's approval. 

In 2016, the FDA allowed medication abortion to be mail-ordered, and since then, some states have enacted their own laws against this practice, and telehealth options, by requiring physicians or clinicians be present while a patient takes the abortion pills — a dayslong process. 

After the appeals court released its decision, the Justice Department appealed and the Biden administration filed an emergency application asking the Supreme Court to intervene. Supreme Court Associate Justice Samuel Alito Jr. ruled April 14 to maintain mifepristone's status quo as the court collected arguments and deliberated the case, thus halting previous courts' decisions. 

Seven days later, the Supreme Court retained the status quo as the case now returns to lower courts. 

What this means for healthcare

Although this poke into the belly of the FDA failed to puncture a hole, it could leave a wound vulnerable to the next legal effort against an approved medication. 

Before the Supreme Court published its final ruling, dozens of biotech and pharma executives signed a virtual petition slamming the plaintiffs' case, saying the argument against mifepristone lacks science and evidence, putting "any medicine … at risk." 

Caleb Alexander, MD, a professor of medicine and epidemiology at Baltimore-based Johns Hopkins University, said he would "fall out of [his] chair if the FDA is forced to rescind approval for this product based on this case." But some states have begun stockpiling mifepristone and misoprostol, the other drug used in medication abortion, in case the pill's approval is pulled.

The FDA declined Becker's requests for comment on the case. Danco Laboratories, a company that makes and sells medication abortion, said the Supreme Court's stay "is an important step in maintaining access to medication abortion during the litigation."

It seems healthcare's muddy waters on abortion policies are not clearing up: Some health systems, such as Dallas-based Tenet Healthcare, are still reeling from the Supreme Court's summer 2022 decision to overturn Roe v. Wade

A conflicting order from a federal judge in Washington state could bring mifepristone's future to the Supreme Court again. As these cases wend through the judicial branch, the nation is waiting to see the color of the bruise on the FDA, which has been operating since the 19th century.

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