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The FDA’s power to approve drugs faces sweeping challenge in lawsuit seeking to pull abortion pill from U.S. market

  • January 24, 2023

Regardless of the outcome in the Northern District of Texas, abolishing federal abortion rights has called into question just how far the FDA’s approval of new drugs extends in a post-Roe America.

The FDA earlier this month allowed retail pharmacies to dispense mifepristone for the first time if they get certified with the federal government and the patient has a prescription from a certified health-care provider.

CVS and Walgreens, the nation’s two largest drugstore chains, have said they are applying for certification and will provide the abortion pill in states where the law allows. But a dozen states have banned abortion in nearly all circumstances, and a number of others have restrictions on dispensing and administering mifepristone that conflict with FDA regulations.

The attorney general of Alabama recently suggested that women could be prosecuted for self-managing abortions with mifepristone. And Florida warned pharmacies in a letter last week that dispensing the abortion pill directly to patients is illegal under state law.

But the FDA’s powers stem from Congress’ constitutional authority to regulate interstate commerce. Lawmakers gave the agency the power to decide which drugs are introduced into the U.S. based on whether they are safe and effective. This raises the question of whether or not the FDA’s approval of mifepristone preempts state laws that ban it for abortions.

Pharmacies, however, are licensed by state boards. As a practical matter, this means states that have banned abortion have the power to revoke the licenses of pharmacies that dispense mifepristone in contravention of local law.

“For retail pharmacies that want to get into this space, they’re going to be looking at risk and the risk that they’re looking at is that they’re in a state with a full abortion ban,” Piatt said. “They’re not going to want to start immediately selling those items for fear of violating the state law.”

The courts have in the past ruled that FDA’s drug approval powers supersede state law. In 2014, Massachusetts tried to ban the painkiller Zohydro, which contains hydrocodone, after declaring a public health emergency in response to the opioid crisis. But a federal district court judge blocked the ban from taking effect, arguing Massachusetts was obstructing the FDA’s mandate from Congress.

“If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health,” Judge Ryan Zobel of the U.S. District Court for Massachusetts wrote.

Just how far the FDA’s authority extends into states with abortion bans that conflict with the agency’s decisions on mifepristone is a question which will be decided in federal courts in the months ahead, Piatt said.

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