‘Domain of the states’: Appeals court says states can regulate abortion pill

The U.S. Court of Appeals for the 4th Circuit ruled on Tuesday in favor of the right of a state to regulate the abortion pill.

Pro-life legal group Alliance Defending Freedom (ADF) noted that the court “rejected a bid by GenBioPro (GBP) — the generic manufacturer of the abortion pill — to federalize the regulation of prescription drugs, including the abortion drug mifepristone” in its July 15th decision in GenBioPro v. Raynes.

Notably, the court stated that the idea that Congress ever “intended to guarantee nationwide access” to abortion drugs is a “flawed premise.”

Key Takeaways:

• The 4th Circuit Court of Appeals, located in Richmond, Virginia, sided with a lower district court in upholding the right of West Virginia to regulate the abortion pill under state law.

• Generic abortion pill manufacturer GenBioPro sued over West Virginia’s abortion law and abortion pill regulations, which it claimed made it “impossible for GenBioPro to promote and market its product [the abortion pill mifepristone]” there and limited “its pool of customers.”

• The Court disputed GenBioPro’s assertions, stating that federal law allows the FDA to “establish minimum safety rules for administering drugs like mifepristone where they may be legally prescribed” but “did not create a right to utilize any particular high-risk drug,” as this would have trampled on states’ rights to protect citizens.

• The Court stated that the Food and Drug Administration Amendments Act of 2007, a federal law, “leaves the states free to adopt or diverge from West Virginia’s path” — meaning states have the right to regulate the abortion pill.

The Backstory:

The West Virginia Legislature passed the Unborn Child Protection Act in September of 2022, which “defines abortion to include the use of any medicine, drug, or other substance ‘with intent to terminate the pregnancy of a patient known to be pregnant and with intent to cause the death and expulsion or removal of an embryo or a fetus,'” explained WV Public.

GenBioPro then brought suit, “arguing that West Virginia’s law overrode Congressional authorization for the Food and Drug Administration (FDA) to exclusively impose restrictions on access to mifepristone via the Food and Drug Administration Amendments Act (FDAAA) of 2007,” WV Public added.

• January 2023: GBP asks the courts to enjoin state officials from enforcing West Virginia’s abortion law.

• August 2023: Court partially dismisses the lawsuit challenging the law, and GenBioPro appeals to the 4th Circuit.

The FDAAA was enacted by Congress in 2007 “to enhance the FDA’s postmarket authority over high-risk drugs,” the court document stated. “Under the FDAAA, the FDA may require a drug’s manufacturer to develop and implement a Risk Evaluation and Mitigation Strategy (REMS) when ‘necessary to ensure that the benefits of the drug outweigh the risks.'”

GBP’s complaint alleged that West Virginia’s abortion law “caused significant, ongoing economic injury to GenBioPro” by “severely constrict[ing] [its] pool of potential customers” in the state, with GBP adding that the law made it “impossible for GenBioPro to promote and market its product in West Virginia as it does in other states.”

The Details:

In its opinion in GenBioPro v. Raynes, Judge Harvie Wilkinson and Judge Rossie D. Alston wrote that the FDAAA leaves states free to regulate access to medication in their jurisdiction.

Perhaps with a hint of sarcasm, the court stated, “Just after the Supreme Court restored the states’ traditional authority to regulate abortion, GenBioPro would have us wrest it right back from them.”

“Domain of the states”

“[T]he object of West Virginia’s law is abortion — an issue within the historical domain of the states,” the court opinion stated. “While it may affect a federally regulated drug, this effect is but incidental to the law’s regulation of abortion. Accepting GenBioPro’s argument would require extending these cases beyond situations where a state law targets a federal domain to those where it merely has some incidental effect on one.”

State law “upstream” from FDA regulation

“West Virginia’s law regulates the incidence of abortion. It determines whether an abortion may be performed at all, prohibiting the procedure in all but a few specific circumstances,” the ruling stated. “In contrast, the FDAAA permits the FDA to regulate how mifepristone… must be prescribed and dispensed if and when a medication abortion is performed. In other words, West Virginia’s abortion law operates in a field upstream from the FDAAA.”

“Flawed premise”

GenBioPro’s “theories rely on the same flawed premise: that Congress intended to guarantee nationwide access to mifepristone when it enacted the FDAAA. We see no indication that it did,” the decision stated.

“The FDAAA authorized the FDA to establish minimum safety rules for administering drugs like mifepristone where they may be legally prescribed,” the court added. “It did not create a right to utilize any particular high-risk drug, which would have constituted a significant intrusion into a state’s traditional authority to protect the health and welfare of its citizens” (emphasis added).

“This interpretation fundamentally misunderstands the FDA’s mission. The agency’s task has always been to ‘ensure[] that drugs on the market are safe and effective.’ FDA v. All. for Hippocratic Med., 602 U.S. 367, 374–75 (2024). It has never been authorized to ‘regulate the practice of medicine’ or mandate that specific drugs be available….” the court stated. It continued (emphasis added):

To read an access mandate into the FDAAA would be to radically redefine the FDA’s historic role and authorize an unprecedented federal intrusion into the regulation of medical practice—an area long reserved to the states….

To the extent that the statute directs the FDA to avoid burdening access to drugs, that directive aligns with its traditional function of ensuring the safety of drugs on the market while leaving the question of access to state governance.

“Free to adopt or diverge”

The court noted that GenBioPro’s argument hinged on the idea that the FDA had “exclusive authority to regulate access to mifepristone,” adding, “We disagree” (emphasis added):

In our view, the Act leaves the states free to adopt or diverge from West Virginia’s path. Because the Act falls well short of expressing a clear intention to displace the states’ historic and sovereign right to protect the health and safety of their citizens, we affirm.

The court also held to the idea that “certain federal standards regulating the distribution of the abortion drug mifepristone” do not “preempt” West Virginia’s abortion laws, agreeing with the lower district court.

“Our decision… is a narrow one,” the judges added. “We take no position on the wisdom or folly of West Virginia’s abortion law. As Dobbs makes clear, that judgment belongs with the people and their elected representatives.”

“System of dual sovereignty”

“We do not suggest that the FDAAA lacks any preemptive effect,” clarified the court. “States are certainly not free to dilute federal safety standards where they have been clearly established. Nor do we deny that Congress may preempt state abortion laws if it chooses to do so and acts pursuant to its enumerated powers.”

The court stated (emphasis added):

We simply hold that it must express that intention with the clarity befitting such a significant alteration to our system of dual sovereignty. Because the FDAAA does not do so, we decline to overturn the West Virginia law…

In our view, the statute means exactly what it says — the FDA can impose safe-use restrictions on high-risk drugs, and those restrictions cannot unduly burden access to the drug. But that does not cut the states out of the picture.

Commentary:

“The Fourth Circuit says that this is really a separation of states rights and federal rights, and typically you can have more restrictive laws,” Sean Tu, a professor at the University of Alabama School of Law, told the media.

ADF Senior Counsel Erin Hawley, vice president of ADF’s Center for Life and Regulatory Practice, claimed the court “rightly refused GenBioPro’s invitation to federalize the issue of abortion” and said “The Fourth Circuit concluded that the Food Drug and Cosmetic Act “create[s] a regulatory floor, not a ceiling.”

Timeline:

• 2000: U.S. Food and Drug Administration (FDA) approves mifepristone as an abortion pill for use up to seven weeks of pregnancy in a regimen with the drug misoprostol.

• 2016: Changes are made, allowing the pill to be dispensed up to 10 weeks of pregnancy and removing requirements that the manufacturer report any adverse events other than death.

• 2019: FDA approves GenBioPro (GBP) to become the generic manufacturer of mifepristone.

• 2021: Biden FDA weakens the REMS safety regulations for the drug by eliminating the in-person dispensing requirement and enables abortion pills to be permanently shipped by mail.

Federal Comstock Laws already prohibit the mailing of abortion drugs, though this provision has not been enforced.

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