ACLU Sues FDA to Remove Restrictions on Abortion Pill

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By Dana A. Elfin

The American Civil Liberties Union Foundation is suing the FDA seeking to undo current restrictions limiting access to the abortion pill ( Chelius v. Wright , D. Haw., No. 1:17-cv-00493, complaint filed 10/3/17 ).

The group, which is suing on behalf of a Hawaii doctor and several professional health care associations, is asking the court to force the Food and Drug Administration to remove the Risk Evaluation and Mitigation Strategy (REMS) currently in place for the abortion pill Mifeprex. Currently, the REMS for the drug prevents women from accessing the pill at retail pharmacies because the restrictions mandate women receive the medication at a clinic, doctor’s office, hospital or from a health care provider who pre-registered with the drug manufacturer and orders and stocks the abortion pill in their health care facility.

The suit says the restrictions aren’t medically justified and place an undue burden on a woman’s access to abortion. If the court rules against the FDA, it will likely mean women will be able to get the abortion pill at local retail pharmacies, giving women greater access to abortions, particularly in states like Hawaii where many abortion clinics have shut down. That’s likely to be political hot potato for the Trump administration and the issues in the case may wind up going to the Supreme Court.

Headed for Supreme Court?

The trial court’s eventual ruling in the case is unlikely to be the final word.

“This case could very well wind up in the Supreme Court,” Roger Gannam, assistant vice president of legal affairs in the Orlando, Fla. office of the anti-abortion group Liberty Counsel, told Bloomberg BNA in a telephone interview Oct. 4.

The case involves highly technical issues because of the layers of regulations involved so it will be very interesting to see how it plays out, Gannam said.

“What we have here is the claimed abortion rights on the one hand running into the deference the courts give to the agencies on the other hand,” he said. It could reach the Supreme Court by 2019, he said.

Previous High Court Ruling

In the meantime, the trial court may wind up looking to the Supreme Court’s 2016 decision in Whole Woman’s Health v. Hellerstedt, which ruled health regulations cannot burden access to abortion without a valid medical justification, New York University School of Law professor Sarah Burns said. “A court may very well draw a parallel between this case and Whole Woman’s Health, where the Texas medical regulations were found to have no medical purpose at all and were struck down as unconstitutional,” she said.

“Plaintiffs put forward a compelling argument that the Mifeprex regulations are not medically necessary and instead that Mifeprex is treated very differently from other drugs with similar risk profiles simply because it is associated with abortion,” Burns told Bloomberg BNA Oct. 4. Burns is a director of the Reproductive Justice Clinic and Advanced Reproductive Justice Clinic at the NYU School of Law.

The other factor will be how heavily this regulation burdens women’s access to medication abortion, she said.

But Gannam said there’s nothing stopping the hospital where the physician plaintiff in this case works from stocking the abortion pill and following the REMS regulations. “It just doesn’t want to,” he said.

Benefits Versus Risks

The Food and Drug Administration may impose REMS restrictions on a drug to ensure a drug’s benefits outweigh its risks. Here, the ACLU said the REMs requirements aren’t justified and effectively cut some women off entirely from abortion services, hitting women in the most rural and medically underserved areas of the country particularly hard.

“The abortion pill is safe, effective, and legal,” Julia Kaye, staff attorney with the ACLU Reproductive Freedom Project, said in an Oct. 3 statement. “The FDA’s unique restrictions on medication abortion are not grounded in science — this is just abortion stigma made law.”

Mifeprex is indicated to end an early pregnancy up to 10 weeks. It’s made by Danco Laboratories, LLC, a privately held company based in New York. Mifeprex has been used by 3.2 million women in the U.S. since the FDA approved it in 2000, Abby Long, Danco’s director of marketing and public affairs, told Bloomberg BNA in an Oct. 4 telephone call.

Danco is aware of the ACLU’s suit over Mifeprex but isn’t commenting on it or on the drug’s REMS, Long said.

Plaintiffs include Graham Chelius, a family medicine doctor on Kauai; the Society of Family Planning; California Academy of Family Physicians; and Pharmacists Planning Services Inc. They are represented by attorneys with the ACLU and the ACLU of Hawaii.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

The lawsuit is available at http://src.bna.com/s4Y.

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