In the abortion pill showdown, will drug and device makers be caught in the crossfire?

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This article is part of an ongoing series examining the implications of the cancellation of Roe v. Wade on the pharmaceutical industry.

Drug and device manufacturers, check your product portfolios. How your medical products are used – or will be used in the future – could have legal ramifications.

That’s the take-home message from a life sciences lawyer following a series of actions this week by senior Biden administration officials.

The measures were intended to preserve access to abortion in states where it became illegal following the overturning of Roe v. Wade. They also come in response to what has been a flurry of access issues involving methotrexate, mifepristone and misoprostol – drugs that can cause abortion but are often prescribed for other conditions.

“Watch your wallets and think outside the box,” advised Eric Alexander, ReedSmith attorney who specializes in drug and device law. “It’s better for companies to have the idea of, ‘How is our portfolio going to play into this?’ It is better to be proactive.

The latest of the administration’s actions was Wednesday’s guidance from the Department of Health and Human Services’ Office of Civil Rights. The four-page memo warned the nation’s 60,000 retail pharmacies that by refusing to fill prescriptions for abortion-inducing pills, they could be breaking civil rights law.

Included was an overview of conditions, ranging from miscarriage to stomach ulcers and ectopic pregnancy, that are routinely treated with the aforementioned drugs. Not distributing such pills, HHS warned, “may be discriminatory” on the basis of gender 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 from violating statewide bans on the procedure.

The measures, experts on both sides of the issue agreed, are designed to affirm that federal law prevails over state law in contexts where abortion is prohibited. They staged a likely showdown – or series of showdowns – in court.

Misoprostol, one of the drugs at the center of controversy, is used to manage chronic stomach ulcers, while mifepristone is prescribed to some patients with Cushing’s syndrome, a hormonal disorder. But they are also approved by the Food and Drug Administration as a combination of two drugs that can be taken to end a pregnancy within its first 10 weeks; they can also be used together after 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 someone 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.

It turns out situations where a state says, “Don’t do that,” and the federal government steps in and says, “Don’t worry. You can,” are not uncommon in the annals of case law, Alexander noted. The deciding factor is often the interplay of state and federal laws – in particular, the right to substantive due process versus the federal Commerce Clause.

Alexander explained that the first is the means by which the 14th Amendment applies the Bill of Rights to states. Generally speaking, the Bill of Rights was written to limit the authority of the federal government. Following a series of substantive due process cases, issues may go all the way to the Supreme Court before being settled.

During this time, states can try to reduce off-label uses. In past cases where they have sought to impose additional restrictions on the labeling or sale of approved drugs, the distinction has certainly been raised.

“The plaintiffs in these cases, those who oppose a preemption, are those who have often argued that there should be a difference whether the product was used in accordance or not,” Alexander recalled. “The prevailing view is that it doesn’t matter.”

In some contexts, the question of label versus label takes on “a weight that it doesn’t really have”, he added. “There are drugs that certainly have every reason to be sold in one 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 medications could frequently lead to legal skirmishes, particularly if physicians’ arsenal is not very broad in the specific therapeutic area. Some cases are already underway, such as mifepristone maker GenBioPro’s challenge to Mississippi restrictions, which was filed ahead of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization.

In addition to exploring the potential for issues with access to any of their drugs after Roe, Alexander suggests that drug and device makers take a proactive stance. He sees a clear line to promotional efforts, especially on the professional side when interacting with prescribers or office staff.

“You should think about what you do in your normal marketing practice,” he advised. “Someone with that kind of bent is going to have a problem with what your salespeople say or what your ads say.”

In the meantime, companies must prepare for other consequences related to the availability of prescription drugs, over-the-counter drugs, and other products that have been approved by the 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 can also have effects on pregnancy. And while the problem persists, it can be difficult for suppliers and businesses to make decisions without legal advice.

“We often talk about slippery slopes,” Alexander said, “but this one is pretty greasy.”

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