Abortion Pills May Force States and the FDA Into a Standoff

For drug-induced abortions, resolving the federal preemption will require new lawsuits, which are likely to be filed in states that are already hostile to abortion, and depending on their outcome, could reach a Supreme Court that has already denied the abortions. rights to abortion. Legal experts are concerned that this could lead to conclusions 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 the case that federal laws and regulations govern the laws of our nation,” 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 be challenges to how we understand this rule of law, and what we’ve known for over 230 years can be undone.”

The day of the Dobbs President Joe Biden and Attorney General Merrick Garland separately stated that the federal government would protect the right of pregnant women to access drugs that cause abortion with drugs: mifepristone and misoprostol. “We are prepared to work with other arms of the federal government that seek to use their legal authorities to protect and preserve access to reproductive care,” Garland said. “The FDA has approved the use of the drug mifepristone. States cannot ban mifepristone because of 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 The sentencing, Xavier Becerra, secretary of the Department of Health and Human Services, said in a media conference that his team will work to increase access to abortion with drugs, but told reporters to “be vigilant” when ask for details.

It is possible that the Department of Justice may defend the rights of the FDA. Goodwin notes that the agency helped lead the fight against Jim Crow’s laws in the early 20th century; she argued The Atlantic in May, revocation of access to abortion creates a “Jane Crow” regime that equally violates constitutional rights. But those who see the evolution of this problem say the most likely scenario is for drug manufacturers to ask.

There is already such a lawsuit: GenBioPro is suing Mississippi because state restrictions go beyond what the FDA has set. That lawsuit was filed before the Dobbs decision, however. Last week, the company and the defendant – Mississippi state health officer Thomas Dobbs, the Dobbs appointed in the Supreme Court decision – filed competing motions arguing whether the Dobbs the Mississippi activation sentence and law that was enacted immediately thereafter invalidated the lawsuit. GenBioPro’s lawyers said their lawsuit against state restrictions should continue.

Whatever the outcome, this lawsuit only addresses Mississippi law. To ensure wider distribution, a company would need a broader challenge. “A drug manufacturer materially affected by a ban could sue nationally or state by state,” says Rachel Rebouché, associate dean of research at Temple University’s James E. Beasley School of Law and one of the authors. of a widely read law review article arguing that there are precedents for preemption. A company could file a lawsuit against a single-state ban, he says, but could ask that state’s federal district court to have its finding applicable nationally to any state where a similar ban exists.

What reinforces the preemption argument, the claim that the FDA trial has more power than state law, is that the agency has examined the abortion pill regimen in a way that few other drugs have. . Mifepristone, which causes pregnancy to end by blocking a hormone that supports the lining of the uterus, is not simply a prescription drug. It is also subject to a rare form of additional control called the Risk Assessment and Mitigation Strategy, which the FDA only implements for drugs with serious side effects. (The imposition of this additional layer of regulation for mifepristone is widely considered the result of political pressure rather than pharmaceutical risk; mifepristone causes fewer adverse events than penicillin or Tylenol.) Both the prescribing physician. the pharmacy that dispenses it must be certified separately by the FDA, and the recipient must read the educational materials and then sign a “patient agreement form.”

“In creating an FDA, Congress said, This is how we achieve a uniform national market for safe and effective medicines. ” says Zettler. “The FDA has considered a wide variety of questions around this drug and has made the careful balance that Congress asked it to evaluate the safety and efficacy of this drug, and has devised this scheme to regulate the 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 overturned the power of the Centers for Disease Control and Prevention to establish mask warrants, and in which the Supreme Court invalidated a warrant. of vaccine established by the Occupational Safety and Health. Administration and shifted the balance of power to regulate emissions to Congress and away from the Environmental Protection Agency. It is a scenario, in other words, in which the power of the federal government is reduced. This inevitably leads to the question of to what extent the power of the FDA could also be reduced.

Preemption is an important issue to consider, says Zettler, 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 could also be important. “

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