This piece is part of an ongoing series examining the implications of the overturning of Roe v. Wade on the pharma industry.
Drug and device makers, check your product portfolios. The way your medical products are being used — or will be used in the future — could have legal ramifications.
That’s the take-home message from one life sciences attorney following a series of actions taken this week by senior Biden administration officials.
The moves were intended to preserve access to abortion in states where it has become illegal in the wake of the reversal of Roe v. Wade. They also come in response to what has been a wave of access woes involving methotrexate, mifepristone and misoprostol — drugs that can induce an abortion but are often prescribed for other conditions.
“Look at your portfolios and think outside the box,” advised Eric Alexander, an attorney for ReedSmith who specializes in drug and device law. “It’s better for companies to get out in front on the idea of, ‘How is our portfolio going to play into all of this?’ It’s way better to be proactive.”
The latest of the administration’s actions was Wednesday’s guidance from the Department of Health and Human Services Office for Civil Rights. The four-page memo cautioned the nation’s 60,000 retail pharmacies that, by refusing to fill precriptions for pills that can induce abortion, they may run afoul of civil rights law.
Included was a rundown of conditions, ranging from miscarriage to stomach ulcers and ectopic pregnancy, that are routinely treated with the aforementioned drugs. Failing to dispense such pills, HHS warned, “may be discriminating” on the basis of sex or disability.
It came just two days after HHS secretary Xavier Becerra told hospitals that, in the context of emergency care, federal law trumps state abortion bans. In other words, even in states where abortion is now illegal, doctors can perform surgical abortions and be protected by federal law against violating statewide bans on the procedure.
The moves, experts on both sides of the issue agreed, are designed to affirm that federal law preempts state law in settings where abortion is banned. They set up a likely showdown — or series of showdowns — in court.
Misoprostol, one of the drugs at the center of the controversy, is used to manage chronic stomach ulcers, while mifepristone is prescribed for certain patients with Cushing’s syndrome, a hormonal disorder. But they are also approved by the Food and Drug Administration as a two-drug combination that can be taken to end a pregnancy during its first 10 weeks; they can also be used together following miscarriages. Providers may refuse to prescribe them for their off-label uses for fear of violating state abortion bans.
Or consider the case of a provider who writes a prescription for methotrexate, a standard immunosuppressive drug, to an individual with rheumatoid arthritis or cancer. A pharmacy may refuse to fill the prescription, or even stock the drug, because it can also be used to terminate a pregnancy.
As it turns out, situations where a state says, “Don’t do this,” and the federal government steps in and says, “Don’t worry. You can,” are not uncommon in the annals of jurisprudence, Alexander noted. The deciding factor is often the interaction of state and federal law — specifically, the right of substantive due process versus the federal commerce clause.
Alexander explained that the former is the means through which the 14th Amendment applies the Bill of Rights to the states. Generally speaking, the Bill of Rights was written to limit the authority of the federal government. Following a series of substantive due process test cases, the issues may go all the way to the Supreme Court before being settled.
Meanwhile, states may try to come down on off-label uses. In past cases where they have sought to impose additional labeling or sales restrictions on approved drugs, the distinction has certainly come up.
“Plaintiffs in those cases, the ones who are opposing a preemption, are the ones who have often made arguments that there should be a difference depending on whether the product was used in an on-label or off-label manner,” Alexander recalled. “The prevailing view is that it doesn’t matter.”
In some contexts, the on-label versus off-label issue gets “a weight that it doesn’t really have,” he added. “There are some drugs that certainly have every reason to be sold in a state for all sorts of indications that have nothing to do with reproductive health.”
As medical practice evolves to fill treatment gaps, state-imposed limitations on drugs could frequently erupt in legal skirmishes, especially if the armamentarium for doctors is not very broad in the specific therapeutic area. Some cases are already underway — such as mifepristone maker GenBioPro’s challenge to Mississippi’s restrictions, which was filed prior to the Supreme Court decision in Dobbs v. Jackson Women’s Health Organization.
In addition to exploring the potential for access issues on any of their medicines post-Roe, Alexander suggests drug and device makers take a proactive stance. He sees a clear through-line to promotional efforts, particularly on the professional side when interacting with prescribers or office staff.
“You should think about what you are doing in your normal marketing practice,” he advised. “Somebody with this sort of bent is going to have a problem with what your sales reps are saying or what your ads say.”
In the meantime, companies should brace for more consequences relating to the availability of prescription drugs, over-the-counter medicines and other products that have been approved by FDA for a variety of indications. This includes not only abortifacients and emergency contraceptives but also drugs that have completely different indications.
There are parallels for medical devices that may have impacts on pregnancy, too. And while the issue drags on, it can be hard for providers and companies to make decisions without legal guidance.
‘We often talk about slippery slopes,” said Alexander, “but this one’s pretty greasy.”