An ongoing lawsuit over Mississippi’s abortion pill restrictions could set a roadmap for the Biden administration and others seeking to ease access to the medication across the country as the US Supreme Court considers overturning Roe v. Wade.
GenBioPro, the manufacturer of generic mifepristone, contends the FDA’s regulations for dispensing and prescribing the pill preempt the state’s stricter requirements, including that a licensed physician prescribe it in person. Constitutional and FDA policy attorneys say that argument may have legs and could serve as a basis for any future lawsuits against state mifepristone restrictions.
“Courts have routinely granted deference to FDA” over states when determining under what conditions a drug can be used safely and effectively, said Delia Deschaine, an attorney at Epstein Becker & Green specializing in FDA regulations.
Mifepristone has gained focus as the administration and reproductive health advocacy groups brace for a potential high court decision overturning the landmark ruling that legalized abortion nationwide. FDA regulation of the pill wouldn’t change if Roe is overturned, but some legal battles could arise over states’ authority to put rules in place that go beyond those recommended by the federal agency.
A hearing is set for June 8 to consider Mississippi State Health Officer Thomas Dobbs’s motion to dismiss the GenBioPro case.
Mifepristone, together with another medication called misoprostol, can be used to end a pregnancy within 70 days of a person’s last menstrual cycle. The drug is subject to a risk evaluation and mitigation strategy, a drug safety program that the FDA can use to make sure the benefits of a medication outweigh its risks.
Under the program, mifepristone can be prescribed by any certified health provider, including physician assistants and nurse practitioners, who must obtain a signed agreement from the patient after counseling and prior to prescribing.
But 32 states have their own laws requiring that the prescriber be a licensed physician, according to reproductive health-care research firm Guttmacher Institute. Alabama, Tennessee, and 17 other states also prohibit the use of telehealth to administer the drug, even though the FDA in December permanently removed the requirement that a person physically visit a health-care provider to get mifepristone.
GenBioPro said in its complaint that Mississippi’s additional requirements severely burden GenBioPro’s “ability to provide, and patients’ ability to obtain, mifepristone.” Mississippi mandates that a patient get mifepristone from a licensed physician and take it in the physician’s presence.
Dobbs says the case should be dismissed because GenBioPro fails to allege it’s suffered a concrete injury. GenBioPro “is also attempting to assert the legal rights of third-party healthcare providers and women,” which the company “has no standing to do,” he added.
Attorneys say GenBioPro or the brand-name manufacturer Danco Laboratories would likely succeed in proving standing to sue over these state restrictions. The Biden administration could also sue through the Department of Justice or file an amicus brief in support of a manufacturer’s legal challenge.
President Joe Biden has said his government will seek to protect abortion access if the Supreme Court overturns Roe, though the White House has so far declined to provide specifics until the high court releases a final decision.
Making the Case
Some case law signals that the US Constitution’s Supremacy Clause could be a successful argument, attorneys say. But states could attempt to defend their own laws by arguing that Congress didn’t give the FDA explicit authority to regulate abortion.
In 2014, the US District Court for the District of Massachusetts granted in part a preliminary injunction against state measures that hindered access to Zogenix Inc.'s FDA-approved opioid drug Zohydro. Then-Massachusetts Gov. Deval Patrick (D) oversaw prescribing and dispensing restrictions after he declared opioid addiction a public health emergency in the state.
The court said Zogenix had a plausible case that the state restrictions infringed on the FDA’s authority under the Federal Food, Drug, and Cosmetic Act to ensure that safe and effective drugs are available to the public.
The Zogenix case “stands for the position that a state law that significantly impedes access to an FDA-approved drug product is preempted by federal law,” Deschaine said.
The US District Court for the District of Maine in 2015 struck down a state law that allowed Maine residents to import prescription drugs from retail pharmacies located in Canada, the UK, Australia, or New Zealand. The court ruled, in Ouellette v. Mills, that the FD&C Act preempted Maine’s law.
Other attorneys say state authority over mifepristone may not necessarily be as clear cut.
“The courts have generally found that the states have regulatory authority over the practice of medicine,” said Wendy Parmet, director of Northeastern University’s Center for Health Policy and Law. A state saying,”'You can only prescribe it from an in-person visit in the first six weeks of pregnancy,’ becomes a very different case than just saying, ‘You can’t sell a drug that’s on the interstate market.’”
Greer Donley, an assistant professor of law at the University of Pittsburgh School of Law, said “if a state tried to explicitly ban mifepristone, there would be a solid case that the law would be preempted.”
“It gets more complicated when the state bans abortion generally, and by effect, these drugs are essentially banned,” Donley, who specializes in reproductive health-care law, added.
Attorneys say states with more stringent medication abortion laws will center their defense around a commonly cited Supreme Court opinion on the explicit authorities granted to the FDA by Congress.
In 2000, the high court in FDA v. Brown & Williamson Tobacco Corp., rejected the FDA’s attempt to regulate tobacco products as a drug, holding “that Congress could not have intended to delegate a decision of such economic and political significance to an agency in so cryptic a fashion.”
The DOJ’s Office of Legal Counsel cited that decision in a May 2019 slip opinion challenging the FDA’s authority over lethal injections used in lawful executions. The OLC said the “regulatory framework for ‘drugs’ and ‘devices’ cannot sensibly be applied” to lethal injections, as these types of substances could never be found safe and effective, since they cause all bodily functions to cease.
But Donley said the FDA has authority to regulate drugs like mifepristone and has done so for decades. Deschaine argued that because these two previous cases don’t explicitly deal with an FDA-approved drug, or the issue of abortion, there “are distinguishing factors that may impact the strength” of a state’s argument.
‘Interstate Powder Keg’
Attorneys say legal challenges could create more certainty in a post-Roe world, where differing state laws are likely to prompt confusion and chill medication abortion access.
“There’s the question about can physicians in one state prescribe to a patient who resides in another state? Can the more restrictive state try to exert authority over actions in the less restrictive state?” Parmet said.
In preparation for a decision overturning Roe, Donley said the FDA could help expand medication abortion access by removing the entire REMS program requirements for mifepristone—a move also supported by reproductive health advocacy groups. Donley said this could make it easier to get mifepristone in Democratic-led states, “where they’re going to see this huge surge of demand of patients coming in from out of state,” if Roe is overturned.
A high court decision handing the authority to regulate abortion back to the states would only exacerbate existing interstate divisions, Parmet said.
“You see the red state legislatures threatening to pass bills that will prohibit actions outside of their state,” Parmet said. “And then you see blue states going and promising to be safe havens and be sanctuaries for women from other states.”
“You’re creating a potential interstate powder keg,” she added.