Supreme Court justices seem skeptical about restricting access to abortion pills: Live updates
Supreme Court justices seem skeptical about restricting access to abortion pills: Live updates

The abortion pill case before the Supreme Court could have ramifications far beyond abortion, potentially undermining the regulatory system for all drugs in the United States.

The lawsuit, filed against the Food and Drug Administration by a consortium of doctors and anti-abortion groups, aims to limit the availability of mifepristone, the first pill in the two-drug abortion regimen. It was approved by the FDA in 2000 and has been used by more than five million women in the United States.

If the Supreme Court sides with the plaintiffs and decides to overturn or invalidate the FDA’s mifepristone regulations, it would be the first time a court has undermined the federal agency’s authority to independently decide the conditions governing when and how a drug can be used.

Drug policy experts and hundreds of pharmaceutical companies have raised alarm over the prospect. Such a ruling could spur lawsuits over other drugs, they say, including those that spark political controversy, such as vaccines or the morning-after pill. The companies say that if they can’t rely on the FDA’s regulatory authority, it could affect their decisions about which drugs to develop and how to make them available.

“The resulting litigation and regulatory uncertainty could destabilize the drug approval process, undermine drug development and investment, stall innovation, and compromise patient health,” said an amicus brief filed by more than 300 leaders of companies and industry associations.

The lawsuit, filed in November 2022, sought to overturn the approval of mifepristone. Last April, Judge Matthew J. Kaczmarik of the Northern District of Texas, a Trump appointee who is a longtime opponent of abortion, issued a preliminary ruling to pull the drug from the market. A panel of the US Court of Appeals for the Fifth Circuit later upheld the drug’s original approval, but reversed changes made by the FDA in 2016 and 2021 that made mifepristone more accessible to patients.

If the Supreme Court sides with the Fifth Circuit and orders mifepristone subject to pre-2016 regulations, patients will no longer be able to obtain a prescription via telemedicine and receive abortion pills by mail. They will need to get mifepristone in person from a doctor and will need to visit the doctor three times during the medical abortion process. Nurse practitioners, nurse midwives and physician assistants will no longer be able to prescribe mifepristone, further limiting patient access.

“If upheld, the Fifth Circuit’s approach could render drug development unworkable and freeze our approvals in time, depriving patients of the benefits of evolving science and imposing outdated, unnecessary burdens on health care providers,” the brief said message to the friend of the pharmaceutical industry.

“Far from being limited to a single drug,” the brief said, such a decision “would wreak havoc on drug development, approval and modification processes.”

The impact of the Supreme Court’s decision depends on how broadly it is pronounced. For example, some legal experts say the FDA could keep the 2016 and 2021 regulations in place while collecting additional data on those regulations in a way that would stand up to scrutiny in court. Also, because the ruling will apply to the FDA and not to abortion providers, some medical abortion services are stockpiling mifepristone and may continue to prescribe and mail-order their supply.

If providers couldn’t get mifepristone, many would only prescribe the second drug in the medical abortion regimen, misoprostol, which is used for other medical conditions and is widely available by prescription. It is used alone in many countries, although it is considered somewhat less effective and more likely to cause uncomfortable side effects such as nausea, chills, and diarrhea.

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