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GenBioPro Gives Up Abortion Pill Suit Against Mississippi (2)

Aug. 19, 2022, 1:32 PMUpdated: Aug. 19, 2022, 4:14 PM

Generic abortion pill maker GenBioPro is ending a challenge to a restrictive Mississippi law on ending pregnancies, effectively closing a legal battle over access to the drug amid the continued fallout spurred by the Supreme Court’s overturning of Roe v. Wade.

GenBioPro on Thursday told the US District Court for the Southern District of Mississippi that it was voluntarily dismissing its lawsuit against a state official. The lawsuit was an attempt for GenBioPro to ensure its abortion pills could be sold in the state. In overturning Roe, the Supreme Court triggered a ban on the majority of abortions across Mississippi.

The outcome marks a missed opportunity for a court to settle whether FDA regulations on a drug preempt state restrictions on access, a hot-button issue in the wake of the high court’s ruling.

GenBioPro however is signaling that it isn’t finished trying to get its product to consumers.

“Given the changed national landscape, we have decided to adjust our strategy,” company president Evan Masingill said in an emailed statement.

“We continue to believe that GenBioPro’s legal strategy is an important path forward to ensuring access to medication abortion care,” Masingill said. “We are committed to using the law to remove unnecessary barriers for patients and providers and we look forward to making an announcement soon about our next steps.”

Mississippi called GenBioPro’s dismissal a victory.

“We are pleased to have again successfully defended Mississippi’s abortion laws,” Attorney General Lynn Fitch said in a statement.

“These laws represent the will of the people and the intent of the Legislature to promote life, protect the health and safety of women, and preserve the integrity of the medical profession. Our victory in Dobbs affirmed the right of the people to pass laws that defend these legitimate public interests,” Fitch said.

Fitch also noted that in the wake of Roe, “all parties” should create laws for “more affordable and accessible childcare, stronger and more equitable child support enforcement, and improved adoption and foster care systems.”

FDA vs. States

GenBioPro had argued in its lawsuit that Food and Drug Administration regulations for dispensing and prescribing mifepristone preempt Mississippi’s stricter requirements, including that a licensed physician prescribe it in person.

Constitutional and FDA policy attorneys anticipated a decision in the case would set a roadmap for the Biden administration and others seeking to challenge state abortion pill restrictions that go beyond what the FDA has deemed necessary.

Mifepristone, together with another medication called misoprostol, can be used to end a pregnancy within 70 days of a person’s last menstrual cycle.

The drug is subject to a risk evaluation and mitigation strategy, a drug safety program that the FDA can use to make sure the benefits of a medication outweigh its risks. Several states require that a licensed physician prescribe mifepristone, even though the FDA has said it is still safe when prescribed by any certified health provider, including physician assistants and nurse practitioners.

A Mississippi law banning most abortions went into effect July 7 after a judge declined a request by the state’s only abortion clinic to temporarily block it. Latham & Watkins LLP attorneys representing GenBioPro in the mifepristone case wrote in a letter filed June 30 that the ban would “further distort” the balance “the FDA struck between risk mitigation and ensuring access to a safe and effective medication.”

Planned Parenthood has received funding from Bloomberg Philanthropies, the charitable organization founded by Michael Bloomberg. Bloomberg Law is operated by entities controlled by Michael Bloomberg.

The case is GenBioPro Inc. v. Dobbs, S.D. Miss., No. 3:20-cv-00652, notice of voluntary dismissal filed 8/18/22.

(Updated with additional context throughout.)

To contact the reporter on this story: Ian Lopez in Washington at ilopez@bloomberglaw.com and Celine Castronuovo at ccastronuovo@bloombergindustry.com.

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Cheryl Saenz at csaenz@bloombergindustry.com