Maryland Democrats defend abortion drug in brief to Supreme Court

Senate Democrats and independents and House Democrats argued that the “FDA’s determination that mifepristone is safe and effective is based on a thorough and comprehensive review process prescribed and overseen by the legislative branch.”

“Since mifepristone’s initial approval in 2000, FDA has repeatedly and consistently affirmed that the medication is safe and effective for its approved conditions of use,” the lawmakers said.  “FDA’s process and conclusions have been validated by both Congress and the Government Accountability Office – and by the lived experience of over 5 million patients who have used the drug in the United States.”

The Justice Department on Friday filed a brief with the Supreme Court seeking to block a Fifth Circuit Court of Appeals ruling restricting the use of the drug. Later the same day, Justice Samuel Alito placed a temporary hold until Wednesday night on the lower court’s ruling.

In her brief to the Supreme Court, Solicitor General Elizabeth Prelogar cited “unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone.”

“To the government’s knowledge,” she said, “this is the first time any court has abrogated FDA’s conditions on a drug’s approval based on a disagreement with the agency’s judgment about safety — much less done so after those conditions have been in effect for years.”

The Fifth Circuit ruling effectively would limit access to the drug, barring distribution of the pill by mail and shortening the period during which the pill could be used. But the appeals panel stopped short of agreeing with U.S. District Judge Matthew Kacsmaryk, who earlier ruled that mifepristone should be banned because the FDA incorrectly approved the drug nearly 23 years ago.

The FDA previously removed restrictions that required in-person doctor visits to prescribe the pill, extended its use through 10 weeks gestation, and permitted dispensing the pill by mail.

Nine Democratic members of the Maryland congressional delegation were among 50 senators and 203 House members signing the amicus brief: Sens. Ben Cardin and Chris Van Hollen, and Reps. Steny Hoyer, Glenn Ivey, Kweisi Mfume, Jamie Raskin, Dutch Ruppersberger, John Sarbanes and David Trone.

Rep. Andy Harris, the sole Republican in the Maryland delegation, has supported legislation restricting abortions. In September 2022, Harris co-sponsored a House bill that would limit abortions after 15 weeks.

“The consequences of the Fifth Circuit’s decision could extend far beyond mifepristone, for it undermines the science-based, expert-driven process that Congress designed for determining whether drugs are safe and effective,” the lawmakers’ brief said. “By permitting the district court to disrupt FDA’s current regulation of mifepristone, the Fifth Circuit has countenanced judicial interference that erroneously substitutes the district court’s judgment for FDA’s scientific determination.”

The senators and House members added: “Providers and patients rely on the availability of thousands of FDA-approved drugs to treat or manage a range of medical conditions, including asthma, HIV, infertility, heart disease, diabetes, and more. Moreover, the prospect of courts second-guessing FDA’s rigorous drug safety and effectiveness determinations will disrupt industry expectations and could chill pharmaceutical research and development.”

Last year, Van Hollen and Cardin were original co-sponsors of the Women’s Health Protection Act, legislation that would codify the protections guaranteed under Roe v. Wade nationwide.

Maryland Gov. Wes Moore on Friday announced a partnership with the University of Maryland Medical System to secure supplies of mifepristone.

“Maryland is going to lead on this,” Moore said Sunday on ABC News’s “This Week.”

In 2020, medication abortion (mifepristone and misoprostol) accounted for 53% of all facility-based abortions, according to research by the Guttmacher Institute.