This piece is part of an ongoing series examining the implications of the overturning of Roe v. Wade on the pharma industry.
When the Supreme Court issued its decision in Dobbs v. Jackson Women’s Health Organization and overturned Roe v. Wade, Americans lost the constitutional right to an abortion. But as legislatures across the country enact greater limits on abortion care, some patients are losing something else: the ability to get their medications. And the access issues, compounded by a patchwork of state laws, have created a confusing operating environment for medical marketers.
Bans and restrictions on abortion are taking effect or are poised to do so in more than 20 states, according to the Guttmacher Institute, an abortion rights advocacy research group. The most restrictive regulations include those of Texas, whose “trigger law” threatens to make performing an abortion a second-degree felony punishable by up to life in prison.
“There’s certainly the potential for a huge chilling effect, which is what we’re seeing at the moment,” said Jennifer Piatt, research scholar at Arizona State University’s Center for Public Health Law and Policy and a deputy director of the Network for Public Health Law.
“The trouble with the Dobbs decision is that there are so many different laws in so many different states right now,” Piatt added. “Even if you take a look at just one specific state, there might be a number of different conflicting abortion restrictions, some with very broad wording and some more tailored.”
Lacking clarity on such laws — and hoping to avoid running afoul of them — healthcare providers have been understandably hesitant to perform certain procedures involving the treatment of serious pregnancy complications. The fear of criminal consequences has even extended to the unrelated use of an abortion medication among patients with autoimmune disorders like rheumatoid arthritis, psoriatic arthritis and lupus.
Women with inflammatory diseases have reported on social media that they’re having trouble getting their methotrexate prescription filled, or even getting it prescribed, in states with abortion bans. The drug has been used for decades to treat rheumatologic conditions but is also used to terminate pregnancies — often in the case of ectopic pregnancies, which start outside the uterus and can put a woman’s health at risk.
That alternate use and legal concerns have given some pharmacists pause. The American College of Rheumatology went so far as to issue a statement calling the methotrexate access problems an “emerging concern” and that it’s tracking the actions of pharmacists closely. The Lupus Foundation of America did the same.
“The laws generally require some form of intent to procure an abortion — administration of a medication with intent to procure an abortion,” explained Piatt. “There would be some serious questions there and arguments as to whether a doctor prescribing a medication for some other indication would have the requisite intent to procure an abortion. That said, I can understand the desire not to become a target of litigation.”
The chilling effect on providers post-Dobbs could affect everything from reproductive care like IVF to contraception, including hormonal implants and intrauterine devices. Technically, access to any drug with the potential to cause birth defects or miscarriage, such as acne drug Accutane or the so-called “morning after” pill, could be impacted.
These issues could get worse before they get better. Piatt said she expects a substantial amount of litigation “to try to tease out the contours of the restrictions in any given state.”
Access to abortion pill mifepristone is at the center of an ongoing Mississippi case involving the drugmaker GenBioPro, which argues that approval by the Food and Drug Administration preempts the state’s trigger ban. Even before the overturning of Roe, conservative states were clamping down on access to mifepristone, which is taken along with misoprostol in self-managed abortion.
The Biden administration has said it will work to increase access to the drug, while patients have already pivoted to mail-forwarding services and telehealth to get around state restrictions. Mississippi said in its latest court filing in the GenBioPro suit that the Dobbs decision has shifted the legal landscape “overwhelmingly in favor” of the state’s authority to limit abortion.
Doctors maintain that state laws shouldn’t supersede a physician’s own judgment. “It is critical that patients be able to access needed medications as prescribed by their doctors in the context of their unique, individual health conditions,” said Dr. Jen Villavicencio, lead for equity transformation at the American College of Obstetrics and Gynecology, in a statement.
Asked about reports of people of reproductive age being denied or potentially being denied needed medications out of concern for a potential pregnancy, Villavicencio, an OB-GYN who specializes in complex family planning, said that prescribing medications that may have a negative impact on a potential pregnancy is not uncommon. Indeed, it’s a scenario with which HCPs are quite familiar. Yet the abortion bans, she said, “Pit people with health conditions against their potential to get pregnant.”
Proponents of right-to-life laws say that’s not their intent.
“If there’s a legitimate on-label use for those drugs — let’s say, misoprostol for an ulcer or mifepristone for diabetes — and the woman is not pregnant, I’ve not heard of any case where they wouldn’t be able to get those drugs, or products like Accutane,” said Alexandra Snyder, an attorney and CEO of Life Legal Defense Foundation. “And if they can’t get them, it’s likely because they are pregnant. Even before Dobbs, no doctor would prescribe that. That would be malpractice.”
How does this chaotic and confusing backdrop affect pharma marketers? It’s one thing to pause an ad campaign after a controversial event. It’s quite another to knowledgeably field medical affairs questions or to compliantly promote health products when abortion bans are rippling across the country and instilling the fear of litigation and criminal charges in physicians and patients.
Companies should “delve into the particular state laws,” advised Snyder. “It all depends on the language, and the language can vary widely.”
Some states, like Arkansas and Missouri, had trigger laws that were set to take effect immediately. Texas and Mississippi are among the states that will soon join them.
Of course, some of those laws were passed a decade ago. As a result, their language may differ from less contemporary statutes — like the one in Arizona, which reinstated a 1901 abortion ban, or in Texas, whose 1925 ban is back on the books until the state’s trigger law kicks in. Still others, like Arkansas, include broad-based protection for unborn children, as opposed to barring specific drugs.
“It would be just like any other product,” said Snyder of the potential impact on marketing. “If a state banned any other product, you can’t market that product in that state. If you’re marketing on the internet…you should not specifically target people in a state where that product is now illegal.”
But many of the state laws are being challenged. Thus health law experts say they’re looking to the outcome of the GenBioPro case to provide more clarity for industry.
“We are in such a state of flux,” said Piatt. “We don’t truly know how far some of these states are actually willing to go with respect to enforcing abortion restrictions.”
