A new legal battle post-Roe: Can states ban FDA-approved abortion pills?

The Roe v. Wade era is over, and the next legal battle over abortion is taking shape. And this fight — over access to medication abortion — could ultimately erode the federal government’s power to decide which drugs are safe and effective.

At the center of it all is mifepristone, the first of two drugs taken to end a pregnancy. Advocates hope the Food and Drug Administration’s decision last December to allow the pill to be prescribed via telehealth and distributed by mail will expand abortion access in a post-Roe world. Opponents fear that it could subvert laws in 13 states with abortion bans poised to take effect imminently or in those that place stricter rules on the use of abortion medications than the FDA requires.

Many anti-abortion states have laws on the books that stipulate that mifepristone must be prescribed or taken in person, or that it can be taken only through the seventh week of pregnancy rather than the 10th, as the FDA allows. And lawmakers in more than a half-dozen states have introduced legislation this year that would ban mifepristone entirely.

“It’s crazy that states are trying to ban access to an FDA-approved drug,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project.

It’s happened only a few times before. In 2014, for example, Massachusetts tried to outlaw use of Zohydro, an FDA-approved painkiller, in response to the opioid abuse crisis. A federal district court struck down the state ban. But that case played out in a very different atmosphere — before the Supreme Court swung to a 6-3 conservative majority that strongly favors the rights of states over those of the federal government. And while the Constitution offers some guidance, it depends on how courts interpret that text.

Whichever view is left standing could have profound implications. If pro-choice advocates prevail, access to medication abortion could be protected in all 50 states. If restrictive states win out, arguing the regulation of medical practice resides with them, medication abortion bans will stand, and precedent would be set for states to exert more control over what drugs are available within their borders — from opioids like Zohydro to the emergency contraception pill known as Plan B.

“It’s going to be a fast-moving and dynamic situation,” said Rachel Rebouché, a law professor at Temple University. “I don’t think anyone can accurately predict what the laws and legal responses will look like as this develops.”

The preemption argument

In legal terms, the issue at play is known as “preemption” — whether states can overrule the federal government on a particular matter of law. The coming battles over mifepristone are entering largely uncharted legal territory.

States cannot approve drugs that the FDA has not approved; the regulatory agency sets a national floor for what can and cannot be prescribed. But it’s less clear whether it also sets a national ceiling, meaning states cannot regulate drugs more harshly than the FDA does.

“It’s an underdeveloped area of the law,” Rebouché said, in large part because “states haven’t really tried to ban FDA-approved drugs before.”

Complicating matters, states have the power under the 10th Amendment to regulate the practice of medicine, which is often interpreted to include how drugs are dispensed. (Regulations on how medications are prescribed, however, are left to the feds.)

Some experts see clear guidance in the Constitution — but, as always, interpreting that document is in the eye of the beholder.

If the nation’s courts swing the other way, giving states the upper hand, that could severely complicate all kinds of routine healthcare, said Peter Pitts, a former associate commissioner at the FDA and president of the nonprofit Center for Medicine in the Public Interest. “If a state can selectively decide whatever FDA-approved products are legal for sale, you could get 50 different standards for what a licensed medicine means,” he said. “It severely impacts the ability of a physician to practice medicine,” by creating uncertainty around what constitutes medical malpractice and what drugs insurers will cover.

Massachusetts’ attempt to ban Zohydro, an extended-release version of hydrocodone, in response to the opioid abuse crisis, got as far as a federal district court, which ultimately struck the policy down, arguing that the FDA’s regulations on the drug trumped the states’.

“The district court basically said to the state of Massachusetts, ‘The FDA’s finding here trumps your determination how the drug should be permitted to be prescribed,’” Rebouché said. The decision was based “on this idea that, when the FDA acts, it’s to make drugs accessible through a uniform policy. And states can’t preempt that,” she said.

But that’s just one case, which was resolved before reaching the nation’s top court. Now, in the wake of the Supreme Court’s ruling striking down Roe v. Wade and ending the national right to an abortion, the picture is entirely different. Rebouché estimates that more than 30 states could bring or be affected by preemption lawsuits related to mifepristone. And those battles will take years to play out.

“I think we’re in an era where you see a lot of skepticism of what is the breadth and scope of agency power,” she added. “There’s a lot of uncertainty.”

Broader implications

If preemption arguments ultimately fail for mifepristone, some experts warn states could try to exert more control on what drugs are available in their borders.

“States could start requiring emergency contraception to be behind the counter,” said Moore. “Or they could require people do X, Y and Z before you can get an IUD.” (As medical devices, IUDs are subject to FDA approval just as drugs are.)

The impact of an eventual ruling could reverberate beyond care related to reproductive and sexual health. If states can go against the FDA, “it would really denude the FDA of regulatory control over medical products sold in the U.S.,” said Pitts, the former FDA associate commissioner.

It could also raise the risk of an unsafe drug reaching consumers. The FDA’s approval of a drug, and the agency’s determinations around when and how it’s used, is the culmination of years of safety and efficacy research by staff scientists. If states disagree, “do they disagree with the FDA’s views on safety and efficacy, or clinical trial design, or their data analysis?” he said. “States don’t have that expertise.”

Pitts argued that efforts to restrict mifepristone don’t stem from concerns about patient safety but about values. If those efforts stand, the repercussions could be widespread and unpredictable.

A state might ban the use of mRNA vaccines or gene therapy because stem cells were involved in their development. In the pandemic, more conservative states could have kept providing hydroxychloroquine as a covid treatment, even after the FDA revoked its emergency-use authorization based on data finding it ineffective.

“It would be total chaos,” Pitts said.