By Lisa Jarvis / Bloomberg Review
It hasn’t been two weeks since the Supreme Court overturned Roe v. Wade, and already the decision is hampering people’s access to drugs; including drugs not used for abortions.
State trigger laws now taking effect, of course, make it harder and sometimes illegal for women to get a medical abortion, the Food and Drug Administration-approved two-pill regimen for ending teenage pregnancies. But emergency contraceptives and methotrexate, a treatment for autoimmune diseases, are also caught up in overbroad interpretations of the abortion ban.
So far, pharmaceutical companies have remained silent about these restrictions. Perhaps many of them just assume that losing mifepristone poses no risk to their results. But any state restrictions on FDA-approved drugs could set a worrying precedent.
“Maybe the industry feels safe right now, but I don’t think it should,” said Rachel Sachs, a professor at Washington University in St. Louis who specializes in FDA and health law. “If states can ban an FDA-approved drug for an FDA-approved purpose, what drugs can’t they ban?” »
Abortion-banning states could also crack down on FDA-approved birth control pills and emergency contraception. Even before the court overturned Roe, some states were attempting to prevent access to drugs for generally accepted but off-label uses, such as Texas’ attempts to criminalize hormones for gender-affirming care for children.
Sachs imagines that human papillomavirus vaccines, opioids and even HIV drugs — all drugs that have sparked controversy — could also be at risk.
A Missouri health care system that initially stopped providing emergency contraception Plan B after the state abortion ban took effect has reversed course in response to the exposure media. But concerns persist about broader access to the pills in states where anti-choice lawmakers seem interested in pushing the boundaries of the abortion ban to include the timing of fertilization (a stretch that would also put IUDs in danger).
Reports have emerged on social media of women with autoimmune diseases having difficulty filling prescriptions for methotrexate. It is a chemotherapy agent that suppresses the immune system, reducing inflammation in diseases such as lupus and rheumatoid arthritis. But methotrexate can also be used to terminate a pregnancy.
Some patients dependent on this drug say they have been asked to return to see a specialist to confirm each prescription refill. Others have simply been denied renewals, according to Steven Newmark, chief legal counsel for the Global Healthy Living Foundation, an advocacy group for people with chronic conditions.
Any potential interruption in treatment is alarming for rheumatoid arthritis patients, many of whom spend years finding a regimen that keeps their condition under control. “Therapy that works can be the difference between spending your days curled up in bed with a push and going to work and being a productive member of society,” Newmark said.
Pharmaceutical companies may be tempted to view these disruptions as overly cautious reactions to a new law that will be clarified in due course. But they should pay attention to the precedent that could be set as states now try to restrict drugs in any way related to abortion.
GenBioPro, the maker of mifepristone, is suing Mississippi over that state’s restrictions on abortion pills, arguing that FDA authority preempts state attempts to regulate access to the drug.
The outcome of this lawsuit and all others filed challenging state limitations could have implications for a variety of other drugs, said Patricia Zettler, a law professor at Ohio State University who focuses on the FDA and the Politics.
Drug manufacturers benefit from nationwide FDA drug regulation. They invest billions of dollars in new drug development assuming that their products, once approved by the FDA, will be available everywhere.
The pharmaceutical industry should not assume that court decisions regarding mifepristone will only affect mifepristone. They should work more actively to ensure that all states allow broad access to all of their products.
Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, healthcare, and pharmaceuticals. Previously, she was the editor of Chemical & Engineering News.