The U.S. Supreme Court announced Wednesday it will review a lower-court ruling that would restrict access to the widely used abortion pill mifepristone, bringing a high-profile battle over reproductive rights back to the same court that overturned Roe v. Wade last year.
The court will hear appeals from the Biden Administration and mifepristone developer Danco Laboratories over access and distribution of the drug. The judges won’t, however, take up a request from conservative group Alliance for Hippocratic Medicine, which has challenged the Food and Drug Administration’s 2000 approval of the medicine. That means that while the court could limit access to mifepristone, its decision won’t affect the pill’s standing as a marketed product.
Arguments will be heard in the spring, with a decision expected by the end of June.
The Biden Administration appealed to the Supreme Court after the 5th U.S. Circuit Court of Appeals ruled to restrict access to mifepristone, challenging an FDA decision in 2016 to make the drug available through online prescriptions and mail orders. The appeals court decision would also only allow use of the drug for the first seven weeks of pregnancy, down from the 10-week period the FDA cleared.
The ruling, though, was stayed by the Supreme Court in April, upholding the status quo while the appeals process continues. The stay also halted an earlier decision by U.S. District Court Judge Matthew Kacsmaryk to suspend the drug’s approval.
Mifepristone, also known under the brand name Mifeprex, is used in combination with another drug called misoprostol for medication abortions. The regimen is used in about half of all abortions in the U.S. Testing and decades of use have shown it to be broadly safe and effective for terminating pregnancies.
While the case before the Supreme Court won’t challenge the drug’s original approval, the outcome could still have far reaching implications for the biotechnology industry. Limiting mifepristone’s use would undermine the FDA’s authority for regulating and evaluating drugs, opening the door for other legal challenges in the future.
The issue marks the latest front in the ongoing fight over reproductive rights, meanwhile. Since the overturn of Roe v. Wade, several states have enacted partial or total abortion bans.
“As the Department of Justice continues defending the FDA’s actions before the Supreme Court, President Biden and Vice President Harris remain firmly committed to defending women’s ability to access reproductive care,” White House Press Secretary Karine Jean-Pierre wrote in a statement Wednesday. “We continue to urge Congress to pass a law restoring the protections of Roe v. Wade—the only way to ensure the right to choose for women in every state.”
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- Source: https://www.biopharmadive.com/news/mifepristone-abortion-pill-supreme-court-appeal/702407/