Politics, Not Science, Will Win the Battle for Mifepristone

Since April 7, when Amarillo, Texas, federal Judge Matthew Kacsmaryk nullified the Food and Drug Administration’s approval of the abortion drug mifepristone, reproductive rights advocates have been decrying (among other things) his ignorance, intentional or not, of science.

“It is clear that the judge disregarded the strong medical argument that we presented in our amicus brief,” declares the American College of Obstetricians and Gynecologists in a statement typical of this line of argument. “Medication abortion has played a critical role in helping people continue to access needed abortion care. It also provides people with an alternative to an abortion procedure; in fact, more than half of people who receive abortion care choose medication abortion.”

Now it is true that abundant medical evidence is on the side of the defendant, the FDA. Mifepristone is safer than penicillin. Serious side effects occur in a fraction of a percent of medication abortions. Carrying a pregnancy to term is far riskier than ending one in abortion.

And it’s true that Kacsmaryk leapt miles outside his mandate and his expertise (if he has any). His 67-page opinion contains every scrap of junk science heaped up by the plaintiffs, the hastily assembled Alliance for Hippocratic Medicine.

But is anyone under the illusion that the judge believes any of these alternative facts?

He knows, we know, that it’s all politics. As for the actual facts — that mifepristone makes abortion more convenient, less painful, and more effective, that the medication has been used in five million U.S. abortions since its approval — these are precisely the data the forced motherhood movement uses against mifepristone, to show that it trivializes and maximizes the extermination of the unborn.

The pro-abortion discourse conjures an image of the robed, Marine-barbered ideologue struggling mano a mano with a lab-coated nerd brandishing “Gray’s Anatomy” — the evil politicized judiciary versus the pristinely impartial biotechnocrats. Reproductive rights advocates root for science to save abortion from right-wing politics.

History belies this distinction. At every regulatory agency — the FDA perhaps more than most — politics and science mix, sometimes harmoniously, sometimes in conflict. This is not a problem. In a democracy, it’s how it should work. And it’s how the left should think, not just to win back mifepristone, but also to achieve lasting reproductive justice.

The Pure Food and Drug Act of 1906, which led to the creation of the agency now called the Food and Drug Administration, was the product of a quarter-century of muckraking journalism about snake oil and chickenless potted chicken, of crusading Christian women and Senate floor showdowns between straight-whiskey state senators and blended-whisky state senators. In short, of politics. And “since then,” reads the agency’s website, “the FDA has changed along with social, economic, political and legal changes in the United States.”

As the government’s guardian of almost everything that touches our bodies, from bottled water to blood plasma, the FDA is the chief agent of public health law and policy. Public health, by definition, is a hybrid of social priorities and persuasion (politics) and preventive health and medicine (science). Just like the courts, the regulatory agency is a place where activists, consumers, corporations, bureaucrats, scientists, and politicians duke it out over bodily autonomy, capitalist exigencies, and public good.

How is this power struggle refereed? “An ideal arrangement would ensure that the FDA’s decisions remain accountable to public values while limiting the extent to which inexpert or conflicted political actors can influence those decisions,” Holly Fernandez Lynch, Steven Joffe, and Matthew S. McCoy, ethicists at the University of Pennsylvania’s Perelman School of Medicine, wrote in Nature Medicine. The authors propose a “division of labor,” where the scientists “make decisions about particular product applications, [and] elected and appointed officials . . . have a role in setting broader policies to guide those staff decisions.”

Congress makes the laws that articulate the mission and purview of the agencies. The president appoints the commissioners and may issue executive orders. Both draw the outlines for the regulators to fill in with details as conditions change. The voters hold these elected officials accountable. The courts hold the system in check. But, Lynch told me, no judge is free to second-guess technical and scientific decisions, as Kacsmaryk did. Numerous federal cases have stressed the “deference” the courts must extend to regulators’ expertise.

This dividing line between science and politics is not straight or impermeable. “The scientists determine whether a drug is safe and effective. But how safe is safe enough? How effective? Reasonable people disagree,” Lynch continued. “You need data, but the data alone can’t tell you whether to approve a drug. They are normative decisions, policy decisions. We the American people should have a say.” Industry — agribusiness, coal lobbies, Big Pharma — tries to have its say too.

Plus, policy decisions often have to be made on the fly during health crises. In drug approval, a big trade-off is “speed versus caution,” Lynch told me.

We saw multiple pressure campaigns play out in the Covid-19 pandemic, on both sides. The Trump administration joined anti-vaccine conspiracy theorists in hyping hydroxychloroquine as a Covid remedy and then pushed for its reauthorization after the FDA revoked emergency clearance when data showed it was not just ineffective against the coronavirus, but potentially dangerous as well. The Trumpians also tried to rush approval of vaccines in advance of the 2020 presidential election, before they were fully vetted. In 2022, a House subcommittee reported that the White House had “deliberately and repeatedly sought to bend FDA’s scientific work on coronavirus treatments and vaccines to [its] political will,” according to its chair.

“I think we can all agree that the issue of hydroxychloroquine has become politicized,” Trump’s FDA commissioner, Stephen Hahn, told ABC News in July 2020. “And it’s a shame because … public health emergencies shouldn’t be about politics.” This statement was followed by a long justification of the agency’s actions. Public health is always political. It requires positive, consistent messaging; misinformation control; reinforcing alliances; and discrediting detractors.

Democrats, for their part, overplayed the effectiveness of vaccines and downplayed positive research on “natural immunity” to Covid, host Meghna Chakrabarti recently argued in public radio’s “On Point.” “When absolutist politics from both Republicans and Democrats met an evolving understanding of Covid and natural immunity, what the country was left with was a hot mess of botched leadership and public health communication,” she said.

One of Chakrabarti’s guests, a member of the FDA’s vaccine advisory committee under Joe Biden, pushed back on the term “natural immunity” and the implication of political malfeasance: “My particular phrase in 2020 [was] ‘survivor-induced immunity.’ I mean, we never say … natural immunity from polio … because if you were naturally immune to polio, you may have been paralyzed.” With vaccination rates already suppressed by disinformation, the Biden administration wasn’t keen on encouraging people to forgo the shot, get sick, and pray to come out alive and immune. Did Biden, like Trump, take his own and his party’s political interests into account? It would be crazy not to, since trust in the administration’s credibility and leadership were critical to managing the pandemic response.

Probably no public health issue drives people as crazy as sex. So it is impossible to remember a single sex- or reproduction-related medical substance, device, or procedure that has escaped pressure campaigns and political combat. First, the Catholic Church vigorously opposed the pill. Then, in the late 1980s, the anti-abortion movement began steering federal and state policy on embryonic stem cell research; it still does. But sex-aversive politics do not come only from the right.

Case in point: emergency contraception. The morning-after pill was approved, with a prescription, for adult women in 1999. The Center for Reproductive Rights, or CRR, sued to have it released over the counter without age restriction. George W. Bush’s FDA slow-walked the drug’s release. After five years of go-aheads and backtracks, the agency’s top women’s health official resigned in protest. In 2009, a federal judge found excessive political interference. In 2011, after reviewing a decade of data, the FDA recommended the sale of the medication over the counter for all girls and women. Then, Barack Obama’s Health and Human Services secretary, Kathleen Sebelius, countermanded the FDA decision, citing concerns about the health of younger teens. Obama supported her decision “as a father of two daughters.”

Denouncements flew. Days later, the administration unveiled a “compromise”: Plan B One-Step would be available to women 15 and older with photo ID proving age — something not many teenagers possess. The manufacturer was peeved. CRR sued. Still, everyone figured the whole thing was just preelection politicking — Obama was running against the Mormon Mitt Romney — and that the court would rule for the plaintiffs. We thought Obama, if reelected, would defer, because that’s what he’d wanted to do all along. This did not happen. The same judge called the administration’s policy “arbitrary, capricious and unreasonable” and reinstated the FDA’s earlier recommendation. The administration appealed and lost again. And in June 2013, after 14 years of haggling, the morning-after pill was put on pharmacy shelves for anyone to carry to the cashier and purchase.

Another morning after — after Dobbs overruled Roe — women started stocking up on emergency contraception. The FDA relabeled the pills to clarify that are not abortifacients; they stop ovulation, not implantation of the egg in the womb. But the antis persist in calling it an abortion pill. The saga is not over.

Of course, politics aren’t just for politicians, and regulation isn’t just for regulators and the regulated. And when none of these parties will move, direct political action is the necessary, right response. While thousands dropped dead from AIDS, the FDA under Ronald Reagan and Bush did nothing. Drugmakers and the FDA moseyed forward at their usual, cautious pace. ACT UP fought back.

From its first meeting in 1987, it led marches and die-ins, worked the phones to the press, and created some of the century’s best political art and agitprop theater, all focused on forcing the government to pay attention, spend money, and get “drugs into bodies” — now. At the same time, ACT UP’s Treatment and Data group schooled itself in immunology and the complexities of the FDA’s drug-approval process, infiltrated the research elites, and designed programs and protocols that put patients first. The activists demanded accelerated approval and compassionate use of experimental drugs for people with serious or fatal, as-yet-incurable diseases; broadly inclusive clinical trials; and close consultation with affected communities, including poor people of color, IV drug users, and women.

The climactic 1988 action, Seize Control of the FDA, was a spectacle of official resistance to these aims and to the despised populations demanding them. Workers stood behind unopenable windows gazing down on demonstrators carrying signs reading “time is not the only thing the FDA is killing,” shouting “drugs into bodies,” and “do your job,” and being carried off by police.

But with astonishing speed, most of ACT UP’s demands were met. Today, many are standard FDA policies. These victories took more than persuading the regulators to do the right thing. ACT UP, a largely white, gay group, reached out to diverse constituencies — communities of color, harm reduction and patient advocates, human rights activists — to awaken public sympathy and shame political actors. The activists were armed with science. But it was unrelenting grassroots organizing; smart propaganda; public education; and noisy, fierce, nonviolent direct action — politics — that turned the ship of state.

Among abortion’s defenders, dueling strategies have emerged. One camp, which includes the mainstream advocates, the Department of Justice, and Department of Health and Human Services, is doing what the mainstream has done for 50 years: go to court. Another, smaller group, whose arguments have been advanced mostly by three Pennsylvania legal scholars, favor a more direct route: Pressure the FDA to exercise its enforcement discretion — that is, the statutory authority to use its limited resources to crack down on some unapproved drugs and leave others alone. The Supreme Court, after all, has ruled that the FDA’s enforcement discretion is not reviewable by the courts.

The first camp accuses the second of acting rashly, politicizing the issue, and threatening the rule of law. Jennifer Dalven, who directs the American Civil Liberties Union Reproductive Freedom Project, “pooh-poohed” the other strategy, as MedPage Today put it. “Taking some sort of non-enforcement action or ignoring the decision, as some have called for, won’t answer all of the problems, both legal and otherwise, that this creates, including the dangerous precedent that this sets for all other drugs in the approval process,” she said. Kamara Jones, Health and Human Services’s acting assistant secretary for the public affairs, tweeted, “People are rightly frustrated about this decision — but as dangerous a precedent it sets for a court to disregard FDA’s expert judgment regarding a drug’s safety and efficacy, it would also set a dangerous precedent for the Administration to disregard a binding decision.” She did not mention that other binding decision, from Washington state.

Camp two reject the charges. “[Our proposal] is not radical,” Drexel University law professor David S. Cohen, one of the three lawyers, told Politico. “These are real strategies within the law.”

And politicization is not the problem, he told me. It’s the solution: “What we’re stressing is that there are political strategies available right now. Meaning we need to put pressure on political actors rather than just to let the lawyers file their briefs and sit back and see what happens.”

Like me, Cohen is not sanguine about seeing what happens when mifepristone meets Samuel Alito. But even if the Supremes uphold Kacsmaryk’s decision, a unique political alliance exists to be mobilized. Pharma is flipping out. More than 400 drug and biotech executives signed a letter condemning the Texas ruling as a mortal threat to the stability of their industry and thus its investment and innovation. This is one of the rare times in political or regulatory history that corporations and humans are on the same side. Danco, the manufacturer of the brand name mifepristone Mifeprex, could apply for fast-track approval, the FDA could review the 20 years of data it has on file, and the drug could be back on the shelves within the year. Danco has an economic incentive to act quickly. But regulators need pushing.

“Political pressure is a role for everyone,” Cohen said. “To me that’s a much more active and involved and hopeful strategy.” Science is critical to winning the day. But science won’t move anyone or anything if no one moves the scientists to act.