Abortion pills can send states and FDA into a tailspin

For medication abortions, addressing federal preemption will require new lawsuits, likely to be filed in states already hostile to abortion, and — depending on their outcome — could reach a Supreme Court that has already denied abortion rights. Legal experts worry that could lead to revelations with broader implications for federalism as a whole. “In more than 230 years of Supreme Court jurisprudence, and the practice of law and the rule of law, it has always been that federal laws and regulations govern our nation’s laws,” said Michele Bratcher Goodwin, professor of law and founding director of the University’s Center for Biotechnology and Global Health Policy. of California, Irvine. “But it’s very possible that there are challenges to how we understand that rule of law, and what we’ve known for more than 230 years may be chipped away.”

On the day Dobbs With the decision, President Joe Biden and Attorney General Merrick Garland separately said the federal government would protect pregnant women’s right to access the abortion-inducing drugs mifepristone and misoprostol. “We stand ready to work with other branches of the federal government that seek to use their statutory authority to protect and preserve access to reproductive care,” Garland said. “The FDA has approved the use of the drug mifepristone. States may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and effectiveness.”

So far, however, there has been no public commitment to action. Four days after Dobbs decisively, Xavier Becerra, secretary of the Department of Health and Human Services, told a news briefing that his team would work to increase access to medication abortion, but told reporters to “stay with us” when asked for details.

It is possible that the Justice Department could defend the FDA’s rights. Goodwin points out that the agency helped lead the fight against Jim Crow laws in the early 20th century; she argued Atlantic may that revoking access to abortion creates a “Jane Crow” regime that similarly violates constitutional rights. But those watching the development of the issue say the more likely scenario is that drugmakers will sue.

There is already one such lawsuit: GenBioPro is suing Mississippi because the state’s restrictions go beyond those set by the FDA. That suit was brought before Dobbs decision though. Last week, the company and the defendant — Mississippi State Health Officer Thomas Dobbs, the Dobbs named in the Supreme Court decision — filed competing motions arguing whether Dobbs the judgment and Mississippi’s triggering law that took effect immediately thereafter invalidated the suit. GenBioPro’s lawyers argued that their lawsuit against the state restrictions should continue.

Regardless of the outcome, that lawsuit applies only to Mississippi law. To ensure wider distribution, the company would need a wider challenge. “A drug manufacturer that is materially affected by a ban could sue on a national or state-by-state basis,” says Rachel Rebouché, associate dean for research at Temple University’s James E. Beasley School of Law and one of the authors of a widely read review of the law arguing that there are precedents for pre-purchase. A company could bring suit against one state’s ban, she says, but could ask a federal district court in that state to make its finding nationally applicable to any state with a similar ban.

What strengthens the preemption argument—the claim that the FDA’s ruling has more power than state legislation—is that the agency has scrutinized the abortion pill regimen in a way that few other drugs have. Mifepristone, which causes pregnancy termination by blocking hormones that support the lining of the uterus, is not just a prescription drug. It is also subject to a rare form of additional scrutiny called the Risk Assessment and Mitigation Strategy, which the FDA normally applies only to drugs with serious side effects. (The imposition of this extra layer of regulation on mifepristone is widely seen as the result of political pressure rather than pharmaceutical risk; mifepristone causes fewer side effects than penicillin or Tylenol.) Both the prescribing physician and the dispensing pharmacy must have separate certifications from the FDA, and the recipient must read educational materials and then sign the “Patient Agreement Form”.

“In creating the FDA, Congress said: This is how we get a national single market for safe and effective medicines.” Zettler says. “FDA has considered a wide range of issues related to this drug and performed the careful balancing that Congress has asked of it in evaluating the safety and efficacy of this drug, and has designed this scheme to regulate the drug. And the question will be: can states deviate from that scheme?”

That question will be raised in a legal context in which a federal court in April struck down the Centers for Disease Control and Prevention’s authority to set mask mandates, and in which the Supreme Court also struck down a vaccine mandate set by Occupational Safety and Health. The administration also shifted the balance of power to regulate emissions toward Congress and away from the Environmental Protection Agency. In other words, it is an environment in which the power of the federal government is being reduced. This inevitably leads to the question of how much the FDA’s power might also be reduced.

Prevention is an important issue to address, Zettler says, because “it could limit the ways states can regulate other types of drugs that are not part of the abortion debate, or it could open the door to more state regulation. Effects outside the context of reproductive health care may also be important.”

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