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HomeHealthGOP states say FDA lacks authority to override state bans

GOP states say FDA lacks authority to override state bans

Boxes of the medication Mifepristone used to induce a medical abortion are prepared for patients at Planned Parenthood health center in Birmingham, Alabama, March 14, 2022.

Evelyn Hockstein | Reuters

The Food and Drug Administration’s power to approve drugs does not override state bans on the abortion pill, a coalition of Republican attorneys general told a federal judge this week.

The 21 GOP attorneys general told a federal court in West Virginia on Monday that it should dismiss a lawsuit filed by GenBioPro, one of the manufacturers of the abortion pill mifepristone. The company has asked the court to overturn West Virginia’s abortion ban, arguing that it conflicts with how the FDA regulates mifepristone under federal law.

The Republicans, in their brief to the court, argued that FDA approval of a drug does not give the manufacturer an unconditional right to the sell the medication at all times. The states have the power to regulate abortion whether it is performed through a surgical procedure or a medication, they said.

The GOP attorneys general said West Virginia’s law does not completely ban the abortion pill. Mifepristone can be used in cases of medical emergency, rape and incest, they said. But the FDA’s powers wouldn’t override West Virginia law even if the state did completely ban mifepristone.

“Even if West Virginia had banned mifepristone, there still wouldn’t be a preemption problem,” the Republican attorneys general argued. Nothing in the statute that governs the FDA prevents a state from banning a drug that federal law otherwise permits, they said.

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GenBioPro has argued that West Virginia’s abortion ban violates the supremacy and commerce clauses of the U.S. Constitution, which give the FDA the power to decide which drugs are sold nationwide.

“Individual state regulation of mifepristone destroys the national common market and conflicts with the strong national interest in ensuring access to a federally approved medication to end a pregnancy, resulting in the kind of economic fracturing the Framers intended the Clause to preclude,” GenBioPro’s lawyers argued in the lawsuit.

“A State’s police power does not extend to functionally banning an article of interstate commerce — the Constitution leaves that to Congress,” the company’s lawyers wrote.

Mifepristone has become a central front in the battle over abortion access in the wake of the Supreme Court’s decision to overturn Roe v. Wade last June. The FDA and companies such as Walgreens have been thrust into the center of that conflict.

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A group of physicians who oppose abortion have sued the FDA in a federal district court in Texas to overturn its long-standing approval of mifepristone. Republican attorneys general in 22 states have also formally backed that lawsuit through a brief filed in support.

The Biden administration, in its response to the Texas lawsuit, said overturning the approval of mifepristone would damage the pharmaceutical industry’s confidence in the FDA, potentially damaging future drug development.

Democratic attorneys general, meanwhile, have sued the FDA in federal district court in Washington state to force agency to drop all remaining federal restrictions on the medication.

Walgreens has also come under fire after announcing that it plans to sell mifepristone but only where it is legal to do so. Republican attorneys general in 21 states warned the drugstore chain against selling the medication in their states. Walgreens said it would not dispense or mail mifepristone in those states.

California Gov. Gavin Newsom on Monday said the state would no longer do business with Walgreens due to the company’s decision not to sell the abortion pill in some states.



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