Can states ban FDA-approved abortion pills? This mifepristone maker is about to find out.

While some states have decided to completely ban abortion following Dobbs v. Jackson Women’s Healthnew questions have emerged about abortion pills: States have the legal authority to outright ban drugs that have been approved by the US Food and Drug Administration?

An ongoing federal lawsuit in Mississippi may provide a glimpse of the answer. GenBioPro, the maker of generic abortion pills, fights to overturn state restrictions that impede access to mifepristone, an abortion pill. Their lawsuit, filed in 2020, hinges on an argument that many legal experts expect other states and defenders to make in the coming months: that Mississippi’s restrictions on medical abortion are unduly excessive, illegally overruling the FDA’s authority over drug safety.

The FDA approved the use of mifepristone in 2000. Over the next 18 years, more than 3.7 million women in the United States used the drug – sold under the brand name Mifeprex – to end an early pregnancy. . In 2016, the FDA reported that “the efficacy and safety of mifepristone have become well established by research and experience, and serious complications have been shown to be extremely rare.” Three years later, the agency approved the generic version of GenBioPro.

Today, medical abortion — a combination of mifepristone and misoprostol — accounts for more than half of all abortions in the United States, and fights over access to the pills are expected to be among the most fiercely contested in the post-era. -Roe.

Just hours after the U.S. Supreme Court overturned deer, President Joe Biden gave a speech promising to protect women’s access to FDA-approved drugs, including mifepristone. Biden announced he was leading the federal Department of Health and Human Services “to ensure these essential medicines are available to the fullest extent possible” and Attorney General Merrick Garland pledged to use the powers of the Department of Justice to crack down on states that attempt to ban medical abortion.

But the Biden administration has remained silent on the Mississippi lawsuit. The White House declined to comment on the matter, as did the FDA and DOJ. HHS did not return requests for comment.

Mississippi has asked for the case to be dismissed. Judge Henry Wingate, a Reagan appointee of the United States District Court for the Southern District of Mississippi, asked both parties to provide written submissions on the impact, if any, of the Dobbs decision on the lawsuit and on Mississippi’s “trigger law” banning abortions, which is expected to go into effect next week. Submissions are due Thursday.

A ruling in favor of Mississippi could have implications for other jurisdictions seeking to ban abortion pills in a post-Roe landscape.

If confirmed, it would also “open the floodgates for states to substitute their judgment for that of the FDA in other controversial areas of medicine – some of which we may know – some of which we may not -be not,” said Delia Deschaine, a DC-FDA regulatory attorney. “For example, if there was a group of individuals opposed to palliative care, a state could potentially limit access to drugs that are approved for use in that setting. This then becomes a situation where the practice of medicine Using pharmaceuticals varies unpredictably between states — creating its own set of public health issues.

What the FDA Means to “Preempt”

Through passage of the Federal Food, Drug, and Cosmetic Act in 1938, Congress gave the FDA authority to approve drugs in the United States. It is responsible for reviewing the safety of a drug, weighing its risks and benefits, and regulating the appropriate conditions for safe and effective use.

Even though many reproductive health experts – including the American College of Obstetricians and Gynecologists – actually say the FDA has too restrictions on mifepristone (for example, only pharmacies or certified providers can dispense the drug), everyone must comply with agency decisions.

But many red states, including Mississippi, have passed laws that go even further than the FDA rules for mifepristone. For example, Mississippi requires a physician to physically examine a patient before offering the drug, and that patients ingest the drug “in the same room and in the physical presence” of the physician who gave it to them, rather than taking the medications at home.

Experts say there is a “strong, if legally uncertain” argument that the US Constitution’s Supremacy Clause gives the federal government authority over these conflicting state rules. Indeed, GenBioPro argued that the Mississippi law is “an impermissible effort by Mississippi to establish its own drug approval policy and directly regulate drug availability in the state.”

This idea — that federal drug regulation would take precedence and that a state cannot ban a drug that has received federal approval — is known as the preemption argument.

For now, legal scholars say it’s unclear how the preemption arguments will play out in court. Courts often give deference to the FDA, although there are relatively few examples involving drugs. The main precedent is a 2014 case in which a federal judge struck down a Massachusetts effort to restrict the opioid Zohydro, since the FDA had approved the painkiller.

“The fact that this case involves a drug used in abortion is one of the reasons we may see the district court take a different position than other courts on this issue,” Deschaine said.

Anti-abortion advocates argue that states have the power to restrict or ban mifepristone because states can regulate medical practice and the FDA does not have the power to regulate abortion. Lawyers also note that Congress has never explicitly said that FDA drug approval supersedes state law, although it has said so for medical devices.

While the DOJ declined to comment on the GenBioPro case, recent public statements from Attorney General Garland suggest the agency is considering the preemption argument. “The FDA has approved the drug mifepristone for use,” Garland said Friday, adding that “states cannot ban mifepristone due to disagreement with the FDA’s expert judgment on its safety and efficacy. “.

What’s next in the GenBioPro trial

Gwyn Williams, an attorney representing GenBioPro, told Vox that in response to the judge’s request, their team submitted a statement reiterating their previous position that the legal issues decided by the U.S. Supreme Court in Dobbs “do not affect GenBioPro’s claims, which are based on federal preemption and not constitutional privacy or abortion rights.” Williams says they expect the judge to issue his decision to dismiss the case soon.

Paul Barnes, a Mississippi assistant attorney general representing the state, declined to comment.

Greer Donley, a law professor at the University of Pittsburgh who specializes in reproductive law, told Vox that one of the reasons the court was “pretty late” in issuing a decision could be because the judge “could try to look for an opportunity to kick the Cas.”

If Mississippi completely bans abortion statewide — which it is expected to do next week, though that trigger law is now being challenged in court — then the state’s restrictions on mifepristone could become not applicable. “If there is a statewide ban, then I can imagine the defendant saying the lawsuit is moot now because all of those laws that regulate abortion providers are subsumed by the greater banning abortion in general,” Donley said.

But Donley says the preemption argument would still have broad merit, since the FDA still acts as a gatekeeper.

“To win the right to sell a drug, manufacturers must produce years, if not decades, of expensive, high-quality research proving the drug is safe and effective,” she wrote, along with law professors David Cohen and Rachel Rebouché in a legal article quoted in the Dobbs CONTESTATION. “If they’re successful, they can sell their product in every state; if that fails, they can’t sell their product anywhere. If a state banned abortion, it would actually be banning the sale of an FDA-approved drug.

In other words, if it is impossible to comply with both state and federal law, there remains a plausible preemption argument.

Deschaine, the FDA’s regulatory attorney, thinks the continued state restrictions on abortion pills could certainly affect whether other pharmaceutical companies seek to go through the FDA approval process. in the future.

“The incentives to develop FDA-approved pharmaceuticals are strong, but those are starting to erode as the regulatory system for these products becomes fractured,” she said. “If a company does not believe that it will be able to market its product in all US states/jurisdictions, it may not be willing to take on the risk of going down the drug approval route. . Indeed, even in the absence of these restrictions, this path is very expensive and uncertain. »

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