Post-Roe, can red states toss FDA rules on abortion pills?

When the Supreme Court overturned the Roe vs. Wade case last month, many abortion rights advocates saw pills sent through the mail as a possible option for pregnant women living in states where abortion is banned.

More than 20 years ago, the Food and Drug Administration approved abortion drugs as safe and effective for terminating an early pregnancy. And last year, partly in response to the pandemic, the agency said the pills could be distributed by a pharmacist or sent directly to a patient’s home by courier or post.

In recent years, two drugs taken in combination – mifepristone and misoprostol – have become the most common form of abortion in the United States, overtaking in-clinic procedures.

But anti-abortion states questioned the safety of these drugs and restricted their use even before abortion rights were repealed. Texas, for example, last year made it a crime for anyone to send or deliver “an abortion-inducing drug” to a pregnant woman.

The federal-state dispute has set the stage for another legal battle that could affect women’s rights in about half the nation.

It is questionable whether the federal regulations on safe drugs could override state laws and, if so, provide a legal option for women who are prohibited from having an abortion.

In response to the June 24 court ruling, President Biden and Atty. General Merrick Garland said they would fight to defend FDA rules.

“States should not ban mifepristone based on disagreements with the FDA’s expert judgment on its safety and efficacy,” Garland said.

A first case testing the problem is pending in Mississippi. It’s one of 19 states that has required a doctor to see the patient when the abortion drug is prescribed, and it also said the patient must be “in the same room” with the doctor when taking the pills.

Two years ago, attorneys for GenBioPro, the Nevada-based maker of a generic version of mifepristone, filed a lawsuit in federal court in Mississippi, alleging its restrictions are extreme and anticipated or overridden by federal law. They argued that the Constitution puts federal law supreme, and they called the state rules “an improper attempt by Mississippi to establish its own drug approval policy.”

US District Judge Henry Wingate had delayed the decision in the GenBioPro case until the Supreme Court had decided the other Mississippi case — Dobbs vs. Jackson Women’s Health — resulting in the June 24 verdict overturning Roe. Now his decision in GenBioPro vs. Dobbs could be the first on whether the federal Drug Act means abortion pills can be legally distributed in anti-abortion states.

“We should make a decision soon, but we will be filing lawsuits in other states as well,” said Ken Parsigian, a Boston attorney representing GenBioPro. “Right now we have the only suit out there and we’d love to see the Department of Justice join us.”

Prosecutors called for the drugmaker’s lawsuit to be dismissed. They said the Supreme Court has given the state “wide powers” to ban abortion, and that includes any “medication or drug” that would terminate a pregnancy.

Legal experts said that both sides in this dispute can claim the law on their side.

“Congress intended the FDA to be the gatekeeper. States cannot replace the FDA and deny the use of approved drugs,” said Rachel Rebouche, a law professor at Temple University. But she said the state also has a strong argument that “it regulates the practice of medicine,” rather than setting drug policy.

She and others said they were not aware of any state banning the use of an FDA-approved drug.

Congress has not said outright that state drug laws always anticipate additional restrictions imposed by a state, and the Supreme Court has been divided on this issue in the past.

Twice in the past few years, judges have ruled in favor of a generic drug maker trying to evade government restrictions. At the time, the question was whether a drug manufacturer could be sued under state law and held liable for a patient’s horrific injuries because the FDA-approved label didn’t go far enough to warn of the danger.

The court’s conservatives ruled in two 5-4 decisions that the federal drug laws took precedence over the state’s additional restrictions.

“Under the Supremacy Clause, from which our preemption doctrine is derived, any state law, even if clearly within the recognized power of a state, that interferes with or contradicts federal law, must yield,” Judge Samuel A. Alito Jr. wrote in Mutual Pharmaceutical vs Bartlett. A lower court had ruled that the manufacturer could avoid the problem by not selling the drug in a particular state, but Alito said, “We reject this stop-sales justification as inconsistent with our preemption jurisprudence.”

But Alito and the court’s conservatives, who just upheld the state’s power to ban abortion, are least likely to uphold the broad reach of federal drug laws when states block the use of abortion drugs.

The Justice Department has not said whether it intends to join the court case to defend the FDA’s rules.

Greer Donley, a law professor at the University of Pittsburgh, said the Supreme Court “has been hostile to administrative agencies, so it may not be best for the FDA to lead the prosecution.”

Parsigian, GenBioPro’s attorney, said he expects a lengthy litigation. “I think we’re going to win in some courts, lose in others, and eventually we’re going to take the issue to the Supreme Court.” Post-Roe, can red states toss FDA rules on abortion pills?

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