Lawsuit against FDA challenges restrictions on abortion pill

On behalf of Graham Chelius, MD, a family physician in Hawaii, and various heath care associations, the American Civil Liberties Union filed a lawsuit to challenge “medically unjustified” federal restrictions that substantially limit access to the abortion pill, according to a press release.

“The abortion pill is safe, effective and legal,” Julia Kaye, staff attorney with the American Civil Liberties Union (ACLU) Reproductive Freedom Project, said in the release. “So why is the FDA keeping it locked away from women who need it? The FDA’s unique restrictions on medication abortion are not grounded in science — this is just abortion stigma made law.”

The FDA restrictions, known as a Risk Evaluation and Mitigation Strategy (REMS), limit where women can receive Mifeprex (mifepristone, Danco Laboratories) — a safe and effective medication for ending an early pregnancy up to 10 weeks, according to the release. ACLU argued that the FDA’s restrictions on abortion medication fail to support REMS protocol, which should only be used to ensure that the benefits of a drug outweigh its risks.

Patients are not able to fill a prescription for the pill at a retail pharmacy, rather women must receive the medication at a clinic, medical office or hospital from a health care provider who is pre-registered with the drug manufacturer and has ordered and stocked the pill, according to the release.

Due to these administrative impediments, many clinicians are not able to fulfill these “unnecessary” requirements, according to ACLU. This process may delay or entirely prevent access to abortion, especially for women in the most rural and medically underserved areas of the United States, according to the release.

“Many people think it’s easy to get an abortion in the U.S., but it’s not. Some women, especially in rural areas, have trouble getting the care they need,” Mateo Caballero, legal director of the ACLU of Hawaii, said. “The abortion pill is a safe, proven method to end a pregnancy — but politically motivated regulations place needless burdens on women seeking this option.”

For example, Chelius cannot stock or provide medication abortion at his associated hospital even though he is qualified and willing to do so, according to the release.

“I believe it’s my moral obligation to provide my patients with the care they need — whether that’s maternity care or abortion,” Chelius said. “Unfortunately, because of the FDA’s restrictions, my patients are forced either to fly to a different provider on another island — resulting in serious delays — or to carry a pregnancy to term against their will.”

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Arranging and paying for an additional trip to another health care provider is often “challenging or insurmountable” for many patients, according to ACLU.

ACLU noted that the American Congress of Obstetricians and Gynecologists (ACOG) support making medication abortion available by prescription at the pharmacy.

“[We believe] that a REMS is no longer necessary for mifepristone, given its history of safe use,” ACOG said in a statement in March 2016. “The REMS requirement is inconsistent with requirements for other drugs with similar or greater risks, especially in light of the significant benefit that mifepristone provides to patients.”

In 2016, the FDA even acknowledged that research and experience prove that Mifeprex is safe and effective to use, with very rare occurrences of serious complications, according to the press release.

“There is simply no medical justification for these restrictions, and they create a needless and harmful burden for women seeking this care,” Paul Blumenthal, MD, MPH, director of the gynecology service at Stanford University, said in the release. – by Alaina Tedesco