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On Friday night, U.S. District Court Judge Matthew Kacsmaryk erased 23 years of American history in just 67 pages. He determined the Food and Drug Administration did not consider all available scientific evidence when it approved mifepristone, the first of two drugs used in medication abortion, and therefore, he ruled the drug's approval violated federal regulatory law.
Unless a higher court intervenes by Friday, Kacsmaryk’s order will rewind America’s clock back before the FDA approved mifepristone in September 2000 — and under the guise of a judicial stay, legal mifepristone will become a proverbial pumpkin at the stroke of midnight.
The immediate, real-life implications of Kacsmaryk’s decision are, as University of Michigan law professor Leah Litman wrote for Slate last week, “pure chaos.” Medication abortion already accounts for more than half of all abortions nationwide. But after the Supreme Court’s decision to overturn Roe v. Wade last summer, medication abortion was expected to become even more prevalent. Indeed, a study published in the Journal of the American Medical Association last November found that requests for self-managed, medication abortion “surged” after the Supreme Court’s ruling, “with the largest surges seen in states with total or near-total bans on abortion,” in part because access to clinical services has disappeared or is shrinking in those states.
Worse, as multiple and/or adjacent states in certain regions ban abortion, those women who are already more vulnerable to maternal mortality are most at risk. Southern, Black women, for example, both seek abortions and die while pregnant or in childbirth at higher rates than other demographic groups. Meanwhile, the South has become a veritable abortion desert, making Black women even more vulnerable. And even if one can get the second drug used in medication abortion, misoprostol, misoprostol-only abortion is both less effective and has greater side effects than abortion achieved by using both drugs together.
Given the draconian impact on women and girls, it’s hard to look beyond this coming Friday, when legal access to mifepristone could end. But on Monday, a group of Americans predicted a truly dystopian future for all Americans, young and old, male and female, if Kacsmaryk’s ruling stands. In a letter released Monday, they lambasted the decision as an “act of judicial interference” that sets “a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry.” Additionally, echoing remarks by Vice President Kamala Harris last month, they argued that “[i]f courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.” If mifepristone isn’t safe, they suggested, neither are the contents of your medicine cabinet.
So who are the people who issued what The New York Times called a “scorching condemnation” of Kacsmaryk’s reasoning and result? CEOs of more than 400 pharmaceutical companies, including Pfizer, the company behind the world’s first authorized Covid-19 vaccine and Paxlovid, an anti-viral medication developed to prevent severe Covid-related illness.
So what’s a Republican-leaning industry giant doing standing up for mifepristone? The best answer might be the least cynical one.
On one hand, Pfizer’s involvement is surprising. Pfizer is not just a Fortune 500 company; it’s in the top 50. And its CEO, Albert Bourla, is a fairly public — and political — person. He has donated to some Democrats, to be sure, but the primary beneficiaries of his largesse have been anti-abortion Republicans, among them Pennsylvania Senate candidate Mehmet Oz, Texas Sen. John Cornyn, Senate Minority Leader Mitch McConnell, and House Speaker Kevin McCarthy. (He’s also given generously to the Republican Party of Kentucky and the national Republican Party committees supporting House and Senate candidates.)
Moreover, Bourla’s railing against the Texas decision seems to go against Pfizer’s economic interest, at least in the short term. As the Times revealed Monday, Pfizer manufactures “a small percentage of misoprostol sold in the United States.” So what’s a Republican-leaning industry giant doing standing up for mifepristone?
The best answer might be the least cynical one: Upholding Kacsmaryk’s decision isn’t just a threat to women’s health and freedom; it reduces the incentives for Big Pharma and start-up biotech firms alike to invest in drug research and development. And those costs are massive. The Washington Post reported Tuesday that "the average cost of bringing a new medicine or vaccine from idea to market is anywhere from a few hundred million dollars to more than $2 billion."
Yes, notwithstanding those costs, Big Pharma can ultimately profit and handsomely when a drug makes it through the FDA's approval process. In 2022, for instance, 57% of Pfizer's revenue came from its Covid vaccines and Paxlovid. But any ruling that discourages drug research and development threatens the greatest harm to at-risk American patients.
That's particularly true given that mifepristone was approved initially through the FDA's Accelerated Approval Program. In the 30 years since that program was created, the FDA has approved 290 drugs. Most of those drugs treat chronic diseases like HIV/AIDS and cancer and/or rare diseases, including three Pfizer medications that each target a specific type of advanced or metastatic cancer.
As hostile as this Supreme Court is to abortion, is there a majority willing to, as The New Republic wrote on Tuesday, "upend the FDA’s drug approval process and a significant portion of the American health care system along with it"?
Pfizer, along with hundreds of other drug companies, now finds itself in an unexpected alliance with the reproductive justice movement. And together, they're hoping the answer is no.