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FDA Defends Abortion Pill Approval in Response to Texas Lawsuit

Jan. 18, 2023, 4:58 PM

A Texas judge should reject an attempt by abortion opponents to halt access to a pill that induces abortions, the FDA said in response to a lawsuit challenging the agency’s decades-old approval of the drug.

An order granting the motion from conservative legal group Alliance Defending Freedom to stop the distribution of mifepristone would improperly undo a “longstanding scientific determination based on speculative allegations of harm,” attorneys for the Department of Health and Human Services and the Food and Drug Administration wrote in a Jan. 13 court filing.

They added that a decision in favor of ADF would also “upend the status quo and the reliance interests of patients and doctors who depend on mifepristone, as well as businesses involved with mifepristone distribution.”

The Biden administration’s response comes as it seeks to maintain abortion access after the Supreme Court’s ruling overturning Roe v. Wade. Legal observers have said that ADF’s challenge, which sits before a Trump-appointed Texas judge, poses the greatest legal threat in years to access to abortion pills in America.

ADF, known for Supreme Court victories such as its protection of a Christian baker who refused to make a wedding cake for an LGBTQ couple, argued in its November legal filing against the FDA that the agency used accelerated approval regulations to improperly characterize pregnancy as an illness. The provisions are supposed to apply to drugs that “are intended to treat serious or life-threatening illnesses” and provide a substantial benefit over existing treatments.

But a 2008 Government Accountability Office report on the FDA’s approval and oversight of mifepristone, known by the brand name Mifeprex, found that the agency properly used its Subpart H authority to impose dispensing restrictions on the abortion pill to defend its safety, including that only authorized prescribers dispense the drug with informed patient consent. The GAO also supported the FDA’s argument that “the termination of an unwanted pregnancy is a serious condition, and that the drug provided a meaningful therapeutic benefit over existing therapies by allowing patients to avoid the procedure required with surgical termination of pregnancy.”

Danco Laboratories, the brand-name manufacturer of mifepristone, filed a motion on Jan. 13 to intervene in ADF’s lawsuit. The company argued that a decision in favor of ADF means “Danco will be deprived of the federal agency approval that has guaranteed public access to Mifeprex for more than two decades.”

ADF senior counsel Julie Marie Blake said in an emailed statement Wednesday that the FDA’s approval of mifepristone “puts a woman or girl’s life at risk.”

“No abortion is safe, and chemical abortions are particularly dangerous, especially when basic facts about a pregnancy are not confirmed via an in-person exam or ultrasound,” Blake said.

The American College of Obstetrics and Gynecology has long defended the safety of mifepristone for use in terminating early pregnancies. Studies show mifepristone is safer and sends fewer people to the ER than Tylenol and Viagra.

FDA Actions

The FDA’s court filing came about a week after it officially approved a plan for pharmacies to get certified to dispense mifepristone. Mail-order pharmacy Honeybee Health is the first certified under the new requirement, and both Walgreens Boots Alliance Inc. and CVS Health Corp. have said they plan to seek certification.

Mifepristone, together with another medication called misoprostol, can be used to end a pregnancy within 70 days of a person’s last menstrual cycle, before the end of the first trimester. Mifepristone is subject to a risk evaluation and mitigation strategy (REMS), a drug safety program that the FDA can use to make sure the benefits of a medication outweigh its risks.

Since the FDA first approved mifepristone in 2000, abortion pill use has steadily climbed among medical providers, and accounted for 54% of all US abortions two years ago, according to the Guttmacher Institute.

Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, No. 2:22-cv-00223, Response in Opposition 1/13/23

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editor responsible for this story: Cheryl Saenz at csaenz@bloombergindustry.com