Soon after the Supreme Court overturned Roe v. Wade, a former Republican congressman made what might sound like an unusual offer. Did abortion pill makers want him to try to get federal legislation passed to explicitly stop states from restricting medications that have been approved by the Food and Drug Administration?
His concern was about more than abortion pills themselves. After his stint in Congress, Jim Greenwood had spent 15 years as the president and CEO of one of the biopharma industry’s main lobbying groups. He figured that the 20-year-old approval of mifepristone might be in jeopardy. If an attempted ban prevailed in court, he knew, it could undermine the country’s infrastructure for evaluating all drugs. “Could states ban vaccines of one kind or another? It’s a slippery slope,” he said, adding, “There are lots of anti-vaxxers in lots of state legislatures.”
Companies expressed interest in his proposal — but that sort of bill would need broad support, and Greenwood ran out of time before Democrats lost the House. And the scenario he worried about is now looming, not only in red states, but in the nation as a whole. An ultra-conservative federal judge, appointed by former President Trump, is presiding over a closely watched case challenging the FDA approval of mifepristone. If he sides with the anti-abortion groups that filed the lawsuit, the decision could potentially set a sweeping precedent. “We’re talking about a judge who is a non-scientist overriding an agency full of experts about the safety and efficacy of a drug,” said Greer Donley, an assistant professor at the University of Pittsburgh Law School. “That, to my knowledge, has never happened before.”
Uncertainty abounds. The outcome depends not only on the judge’s ruling, but how he writes it. It will almost certainly be appealed. It may well end up at the Supreme Court, in front of the same justices that overturned Roe. In other words, abortion pills are teetering on the edge of a legal precipice. If they fall, that would entail the immediate loss of the safest, most effective, least invasive method of first-trimester abortion, which is also the safest, most effective, least invasive method of treating miscarriage, an exceedingly common issue. But that could affect all sorts of other drugs — from those that have been prescribed for decades to those that haven’t even been developed yet. Let mifepristone go over, and any medicine could end up wobbling on that cliff, too.
If drugmakers are up in arms, though, the message isn’t necessarily getting to reproductive rights activists. “When is pharma going to understand what’s at stake here?” asked Kirsten Moore, creator and director of the Expanding Medication Abortion Access project. Some might see this as an opportunity for the industry to redeem itself. What goodwill it might’ve generated with rapid-fire Covid-vaccine development was recently blown up by price hikes — and that’s just one instance in which the interests of CEOs and of public health didn’t align in the public eye. Another was the recent news of drugmakers blocking access to their life-saving medications in poorer countries in order to keep the revenues high in richer ones. Yet redeeming yourself in the eyes of some could mean losing the support of others. Speaking out about abortion could alienate some of biopharma’s Republican allies, even when it dovetails with protecting the regulatory framework the entire business is built on.
Some industry leaders have been very vocal. “If this injunction is issued, it will have an enormous consequence on the provision of critical care to women,” said Jeremy Levin, CEO of Ovid Therapeutics, warning that restricting this kind of care would threaten patients’ lives. He also called it “a potential dagger at the heart of our industry.” As he explained, “Here, you’re not just challenging the right for a woman to treat a pregnancy or to treat miscarriage; you’re also now challenging the primacy of the FDA to approve vast, important medicines that are critical to our society’s health, and that has a fundamental impact on the entire nation.”
Others have been more circumspect in speaking out about the fall of Roe and its effects. To Sheila Gujrathi, a former CEO who now sits on the board of a number of companies, the industry-wide reaction has been “a little disappointing.” She’s one of the founding members of a group of women executives — the “biotech sisterhood” — working to advocate for women’s health and promote diversity in a business that is overwhelmingly dominated by men. “We are trying to take some action, raise awareness, and take a stand. Because if you don’t take a stand, you’re effectively still making a decision. That’s one thing that I’ve learned through this whole process, that remaining silent is a decision.”
The FDA as we know it — the FDA that approved mifepristone 23 years ago — was forged by a desire to protect pregnant mothers from the possible harms of prescription drugs. The year was 1962. There had been Senate hearings over concerns about high drug prices and patients being misled by the industry’s advertising when the thalidomide scandal broke. Initially used as a sedative, the drug had then been prescribed for colds, flu, nausea, and morning sickness, with one ad proclaiming that it could “be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child.”
That turned out to be horrifically wrong. When taken during pregnancy, the drug could cause death at birth or soon after, or severe congenital disabilities. It had never been approved in the U.S. — insufficient safety data, the FDA’s medical officer said — but a company had already sent out the medication to some 1,200 physicians. That, combined with news of the tragedy elsewhere, spurred lawmakers to strengthen the FDA’s authority, such that pharma would have to prove a product’s effectiveness with carefully designed studies before it hit the market, and report any serious side effects that emerged after the fact.
Sixty years later, that process is being challenged by this lawsuit. In their complaint, anti-abortion groups and physicians claim that the agency put politics over science, never studied the safety of mifepristone as it’s used, failed to show that the pills have a therapeutic benefit over abortion procedures, and overlooked harms — claims the American College of Obstetricians and Gynecologists say are spurious. That organization and others point to the decades’ worth of data proving that mifepristone, in combination with misoprostol, is over 95% effective and extremely safe, requiring emergency medical intervention in less than 0.2% of cases.
Part of the plaintiffs’ argument is based on semantics. They write that “pregnancy is not an illness,” and thus that the FDA went beyond its regulatory authority in approving this drug under a specific set of rules. But the agency has a long history of regulating treatments for “conditions” that are not technically “illnesses” — menopause, for instance. Plus, the program under which mifepristone is currently approved has a congressional mandate that makes explicit the agency’s ability to regulate treatments for both categories of health issues. “This is just an attempt to find some ridiculous loophole in the language,” said Donley, at the University of Pittsburgh.
Experts in FDA regulation are in agreement: For a judge to overturn the approval of mifepristone would be to ignore decades’ worth of settled law. But that’s why these anti-abortion groups have brought this case in front of this particular judge. In one previous decision, he claimed that an anti-discrimination law did not protect against discrimination on the basis of sexual orientation; in another, he claimed that a federal program that provided grants for family planning was unlawful because it didn’t require providers to get parents’ permission before treating teenagers. “He’s now become sort of a magnet, because he’s known to be a complete wildcard,” said Beth Parker, a reproductive rights attorney. “So plaintiffs are forum-shopping and filing cases in front of him because they know he will issue decisions that most lawyers are appalled at.”
There have been other challenges to the FDA’s decision-making, but the ultimate authority has always remained with the agency. In 2014, Massachusetts tried to restrict an approved opioid, but a judge sided with the federal scientists. In 2022, a congressional investigation found that the FDA’s review and approval of the Alzheimer’s drug Aduhelm was “rife with irregularities” — but it did not override the decision or strip away the mandate that Congress had given the agency in the first place.
To some, there’s a fundamental question of standing. Do these anti-abortion groups have a direct enough connection, a claim of personal harm, that would allow them to proceed with the case at all? If the lawsuit had been brought by patients who’d claimed they’d been injured because of this drug, that would be a different story. But if these plaintiffs get what they want, that could open the door to any third party challenging any medication that rubs them the wrong way.
“What’s next?” said Paul Hastings, CEO of Nkarta. “Is it hormone therapy for a transgender person? Is it birth control? Is it a certain drug for an inflammatory disease, because it was made from a stem cell that gets misinterpreted as a fetal stem cell?”
Others in the industry expressed worry about Covid-19 medications, weight loss medications, HIV medications, sickle cell medications — any class of medicines that might be politically unpopular for one reason or another. When asked whether they were intentionally trying to set a precedent of overturning FDA approvals and whether there were other drugs they hoped to challenge themselves, an attorney representing the anti-abortion groups who brought the lawsuit suggested that they didn’t have other medications in mind. “We are not aware of any other such example of egregious regulatory and medical malpractice spanning over decades by the FDA,” wrote Julie Marie Blake, senior counsel at the conservative Alliance Defending Freedom, in an email.
Intentional or not, their lawsuit could open the door to others. “The moment there’s a legal precedent that you can overturn the FDA’s authority by choosing your jurisdiction to match your ideology, we are in a very, very dangerous spot. Every drug becomes fodder for the same outcome, and patients are going to be harmed,” said Amanda Banks, a practicing physician, member of the biotech sisterhood, advisor to Harbinger Health, and former CEO of Blackfynn.
Even drugs that don’t exist yet, industry leaders say, could be threatened by this decision. Companies are often looking years down the line as they figure out which diseases to invest in. For a judge in one jurisdiction to override the FDA injects a huge extra dose of uncertainty into that calculus. Entrepreneurs would have to try to predict not only unmet medical needs, but also political headwinds — and that would make investors hesitant. “The same regulatory process which has enabled better choices for women in reproductive health care is one that we have confidence in, independent of which area of medicine we work in,” explained Shehnaaz Suliman, CEO of ReCode, and a member of the biotech sisterhood. “And so, with legal challenges like this, we would hate to see an undermining of that fundamental regulatory process, because we all depend on it for the next wave of innovation.”
Anti-abortion laws have already restricted access, in some cases, to medications for other conditions. Patients have had trouble getting methotrexate, which is used to treat cancer, arthritis, psoriasis, and lupus, because it could possibly cause pregnancy loss and so some states classified it as an abortion-causing drug. And Grace Colón, who was a longtime CEO of InCarda Therapeutics, and is a member of the biotech sisterhood, worries that that will prevent much needed research and investment in diseases like endometriosis or polycystic ovarian syndrome. “If that is suddenly complicated by the fact that some of the drugs and interventions needed could be interpreted as providing fertility, birth control, or abortion care, then all of a sudden, you’re going to have investors running the other way,” she said.
It’s perhaps telling that one of the most vocal biopharma groups defending reproductive rights is a network of women CEOs, formed to help diversify the C-suite and the boardroom — an answer to the old boys’ club. True, they have plenty of male allies in industry leadership. And a number of pharma giants, including Gilead, Sanofi, and BeiGene, have pledged to cover their employees’ travel expenses should they need to travel to seek reproductive health care after the fall of Roe. Some have made public statements.
Still, this is the same industry in which one of the most important conferences had more men named Michael as presenters than it did women CEOs. That was in 2018. Perhaps it’s not surprising that some important players have tried to sidestep saying anything about reproductive health itself. You can see such careful distance in the response of big industry groups when asked about their stance on this lawsuit.
“While not commenting on the specifics of this case, BIO supports FDA as the regulatory authority in the U.S. to make a determination of safety and efficacy, and once they act, we support ensuring patient access to these medicines,” wrote Cartier Esham, chief scientific officer of the Biotechnology Innovation Organization, the lobbying group that Greenwood led for 15 years.
At Pharmaceutical Research and Manufacturers of America, the vice president for public affairs, Priscilla VanderVeer, wrote something similar by email — showing clear support for the FDA while avoiding the hot button issue at hand. “The FDA is the gold standard for determining whether a medicine is safe and effective for people to use. While PhRMA and our members are not a party to this litigation, our focus is on ensuring a policy environment that supports the agency’s ability to regulate and provides access to FDA-approved medicines.”
The Association for Accessible Medicines, the lobbying group for generic drugmakers, meanwhile, simply said, through spokesperson Allen Goldberg, “We aren’t engaged in the issue.”
Some of that hesitation may have to do with the nature of these groups, which represent all sorts of companies and executives with all sorts of political views. They often prefer to stick to causes that every member company can agree on, such as legislation that might limit drug prices and, in the industry’s view, slow down innovation. Neither of the two American makers of mifepristone — Danco Laboratories and GenBioPro — belong to any of these industry groups.
It may also have to do with a political calculus. As Greenwood sees it, Republicans have tended to be more on the industry’s side when it comes to drug pricing and other issues, and speaking out about this lawsuit would certainly go against the views of many in the GOP. “In politics, it’s always risky to antagonize your allies,” said Greenwood, the former president of BIO, specifying that he does not speak on behalf of the group.
It’s entirely possible that such organizations will choose to use their political firepower as the case progresses. “Most of the industry, in my experience, is reactive, not proactive,” said Marc Scheineson, a health care lawyer at Alston & Bird and a former FDA associate commissioner. There will be plenty of opportunities. As he put it, “This is probably round one of a 12-round heavyweight boxing match.”
He’s clear about the possible implications, both for the workings of the government and for everybody’s health. “You want the court to decide what drugs are safe and effective? Well, good luck to all of us,” he said. He doubts that’s what the judge would decide in this case; then again, he didn’t think the Supreme Court would overturn Roe.
Sarah Owermohle contributed reporting.
This story is part of ongoing coverage of reproductive health care supported by a grant from the Commonwealth Fund.
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