Abortion pills may force states and FDA to clash

For medical abortions, settling federal preemption will require new lawsuits, which will likely be brought in states already hostile to abortion and, depending on their outcome, could be taken to a Supreme Court that has already denied the right to medical abortion. ‘abortion. Legal experts fear this could lead to conclusions with broader implications for federalism as a whole. “In over 230 years of Supreme Court jurisprudence and the practice of law and the rule of law, it has always been that federal statutes and regulations govern the laws of our country,” says Michele Bratcher Goodwin, professor of law and founding director of the Center for Biotechnology and Global Health Policy at the University of California, Irvine. “But there may very well be challenges in how we understand this rule of law, and what we have known for over 230 years may be eroded.”

The day of the Dobbs In the decision, President Joe Biden and Attorney General Merrick Garland separately said the federal government would protect the right of pregnant women to access drugs that induce medical abortion: mifepristone and misoprostol. “We stand ready to work with other branches of the federal government that seek to use their legitimate powers to protect and preserve access to reproductive care,” Garland said. “The FDA has approved the use of the drug mifepristone. States cannot ban mifepristone due to disagreement with the FDA’s expert judgment on its safety and efficacy.”

So far, however, there has been no public commitment to action. Four days after the Dobbs decision, Xavier Becerra, secretary of the Department of Health and Human Services, said at a press briefing that his team would work to increase access to medical abortion, but told reporters to “stay tuned. ‘listening’ when they asked for details.

It is possible that the Department of Justice will defend the rights of the FDA. Goodwin points out that the agency helped lead the fight against the Jim Crow laws of the early 20th century; she argued Atlantic in May that the cancellation of access to abortion creates a “Jane Crow” regime that also undermines constitutional rights. But those watching this issue evolve say the more likely scenario is that drugmakers will sue.

There’s already such a lawsuit: GenBioPro is suing Mississippi because the state’s restrictions go beyond those the FDA has set. This lawsuit was brought before the Dobbs decision, however. Last week, the company and the defendant — Mississippi State Health Officer Thomas Dobbs, the Dobbs named in the Supreme Court ruling — filed competing motions to determine whether the Dobbs decision and the Mississippi trigger law that came into place immediately afterwards invalidated the lawsuit. GenBioPro’s attorneys said their lawsuit against the state restrictions should go forward.

Regardless of the outcome, this lawsuit relates only to Mississippi law. To ensure wider distribution, a company would need a wider challenge. “A drugmaker that is materially affected by a ban could sue nationwide or state by state,” 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 law review article that argues that there are precedents for preemption. A company could sue a single state’s ban, she says, but could ask that state’s federal district court to make its ruling applicable nationwide to any state where a similar ban exists. .

What strengthens the preemption argument – the claim that FDA judgment has more power than state law – is that the abortion pill regimen was reviewed by the agency of a way that few other drugs have been. Mifepristone, which causes pregnancy to end by blocking a hormone that supports the uterine lining, is not just a prescription drug. It is also subject to a rare form of additional scrutiny called a risk assessment and mitigation strategy, which the FDA otherwise only deploys for drugs with serious side effects. (The imposition of this extra layer of regulation for mifepristone is widely seen as the result of political pressure rather than pharmaceutical risk; mifepristone causes fewer adverse events than penicillin or Tylenol.) The Clinician prescriber and dispensing pharmacy must be separately certified by the FDA, and the recipient must read the educational material and then sign a “Patient Consent Form.”

“In creating an FDA, Congress said: This is how we get a uniform national market for safe and effective drugs.” Zettler said. “The FDA has considered a wide variety of issues regarding this drug and performed the careful balancing that Congress has asked it to do regarding the evaluation of the safety and effectiveness of this drug, and has proposed this drug regulatory system, and the question will be: can states deviate from this scheme?

This question will be asked 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 struck down a vaccine mandate set by security and the Occupational Health Administration and shifted the balance of power to regulate emissions toward Congress and away from the Environmental Protection Agency. It is a context, in other words, in which the power of the federal government is reduced. This inevitably leads to the question of how much the power of the FDA could also be reduced.

Preemption is an important issue to watch, says Zettler, because “it could limit how states can regulate other types of drugs that aren’t part of the abortion debate, or it could open the door to more.” of state regulation. Effects outside the context of reproductive health care could also be important.

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