Former U.S. Food and Drug Administration officials who served under Republican and Democratic administrations urged the U.S. Supreme Court to reverse a Texas federal judge's order invalidating the agency's approval of a widely used abortion medication, saying "judicial second-guessing of FDA's safety determinations would have serious negative consequences for the public health."
On Friday, shortly after U.S. Supreme Court Justice Samuel Alito issued a five-day stay while reviewing lower court orders blocking access to mifepristone, 10 former FDA officials and 20 food and drug law scholars warned the U.S. Supreme Court of "catastrophic consequences" that may result if inexpert judges undo agency approvals of the drug, saying in amicus briefs that the judge's actions could deprive patients of life-saving medication.
The justices should "refrain from interfering with FDA's determinations of drug safety and efficacy rationally supported by scientific evidence for at least two reasons: congressional intent and agency expertise," the former agency officials said.
The officials — including Rachel Sherman, who served in five administrations beginning in 1989, most recently as principal deputy commissioner of food and drugs during the Trump administration — explained that the agency's modern authority over drug approvals came about in response to a series of public health crises, including a tragic incident involving a raspberry-flavored toxic elixir that killed more than 100 people in the 1930s.
In response, Congress passed the Food, Drug, and Cosmetic Act of 1938, empowering the FDA to create a premarket approval system to prevent dangerous drugs from reaching the market.
As a result, drug manufacturers today must prove, through rigorous studies and reliable data, that their products are safe and effective, the former FDA officials told the justices, assuring them that the agency's approval process is "thorough and science-grounded at every stage."
The district court's order "is the first time that any court has second-guessed FDA's determination that a drug is safe and effective," the former officials said, urging the justices to grant the U.S. Department of Justice and Danco Laboratories' applications for a stay and, after full briefing on the merits, undo the Texas court's preliminary injunction.
If the Supreme Court allows the lower court's rulings undoing the FDA's approvals of mifepristone to stand, the former agency officials warned that it would undermine Congress's chosen scheme, "opening the door to endless re-litigation of FDA's decisions with potentially disastrous consequences."
"Patients who suffered from rare side effects could seek to pull drugs from the market notwithstanding the proven benefits of the drug to vast numbers of other patients. Drug companies could try to pull their competitors' drugs from the market based on a supposed mismatch between clinical trial conditions and the recommendations listed on the label," they told the court. "And companies that invested millions of dollars into a drug that FDA rejected could seek a second opinion from the courts."
The courts don't have the expertise to make the scientific and clinical determinations to evaluate new drugs' safety and efficacy, the former FDA officials said.
"These cases would require inexpert judges to be proficient in exactly what FDA's experts have spent their lives training to do. And as history shows, getting it wrong could lead to catastrophic consequences, whether it were to result in allowing an unsafe or ineffective drug to be sold to the public or depriving critically ill patients of access to a safe and effective remedy," they said.
The FDA approved mifepristone about 23 years ago for use in tandem with the drug misoprostol to end early-stage pregnancies.
In November 2022, anti-abortion groups and physicians sued the FDA in Amarillo, Texas, just months after the U.S. Supreme Court — in a majority opinion penned by Justice Alito — overturned Roe v. Wade .
The plaintiffs sought to undo the agency's approvals of mifepristone, which is available as a generic and under the brand name Mifeprex. It accounts for more than half of all abortions in the U.S. and is routinely prescribed for miscarriage treatment.
U.S. District Judge Matthew Kacsmaryk, who was appointed by then-President Donald Trump in 2019, ruled in an April 7 order that the abortion pill opponents had a substantial likelihood of success on the merits and blocked the effective date of the FDA's 2000 approval and subsequent approvals of mifepristone while the lawsuit plays out.
Almost immediately after the Texas order came down, however, a Washington federal judge issued a conflicting order in a separate case.
U.S. District Judge Thomas O. Rice, who was appointed by former President Barack Obama in 2011, preliminarily enjoined the FDA from limiting the availability of mifepristone in 17 states and the District of Columbia — jurisdictions that had sued the agency to preserve access to the drug.
The Biden administration and Danco, which is the brand name manufacturer of mifepristone, filed emergency motions to the Fifth Circuit seeking to stay the Texas court's ruling. The plaintiffs, who "neither take nor prescribe" mifepristone, had shown no irreparable harm would befall them if the FDA approval remained intact and therefore lack standing, they told the Fifth Circuit.
The Fifth Circuit issued a midnight order on April 12 partly upholding Judge Kacsmaryk's ruling. The panel's order would not have revoked FDA approval of mifepristone entirely but would have reinstated pre-2016 restrictions on it.
Judge Kacsmaryk's injunction was set to partially go into effect beginning at midnight on April 14.
But the DOJ and Danco submitted emergency applications to the Supreme Court that day taking aim at what they called flawed standing analysis by the Fifth Circuit in its late-night ruling.
If the Fifth Circuit ruling stays in place, Danco would be unable to conduct its business, it said, asking the high court to either fully stay the Texas court's injunction or to grant certiorari, expedite briefing and hear argument in the case before its summer recess.
The DOJ likewise urged the Supreme Court to stay the district court's "destabilizing order in full" in order to preserve "a status quo that has been settled for years."
The DOJ further told the Supreme Court that the Fifth Circuit had "fundamentally misunderstood the record," and that even a decision limiting the district court's order to the FDA's pre-2016 restrictions on the drug, as the Fifth Circuit intended to do, would block mifepristone from being introduced into interstate commerce, until the drug's labeling can be updated.
The Fifth Circuit's decision would reinstate pre-2016 restrictions on the drug, cutting off access to telehealth abortion care and barring the distribution of the pill by mail. It also would reinstate three mandatory in-person doctor visits and reduce the gestational limit for dispensing from 10 weeks to seven.
"And it is unclear how FDA could take those steps without risking contempt under the Washington injunction," the DOJ said.
When Justice Alito paused the Texas decision, he ordered that any response to the application be filed by Tuesday.
Counsel for the anti-abortion groups and physicians, Alliance Defending Freedom's senior counsel Erin Hawley, said in a statement Friday that the district court decision would "restore the critical safeguards for women and girls that were unlawfully removed by the FDA."
Twenty food and drug law scholars affiliated with various U.S. universities ripped into the lower courts for second-guessing the FDA's mifepristone approvals, saying in their own amicus brief Friday that the lower courts' orders "rest on critical misunderstandings of federal food and drug law and the underlying regulatory history for mifepristone."
The experts argue that the lower courts' orders upend the drug regulatory scheme established by Congress by replacing the FDA's scientific and medical expertise with "the courts' own interpretations of the scientific evidence."
The food and drug law experts pointed to instances where, they say, lower courts have erred in their rulings based on fundamental misunderstandings of the law.
For instance, the lower courts had failed to grasp that clinical trials are conducted under more restrictive conditions than those for approved labeling, nor did they understand that "whether a particular drug product is well-suited for a particular patient is generally a practice of medicine question that is outside FDA's purview," they told the justices.
The experts further noted that the lower courts' did not acknowledge that FDA regulations impose robust post-marketing adverse-event reporting requirements on new drug application holders for all drugs, including mifepristone.
The lower courts' remedies are "statutorily improper," the experts said, warning that such rulings would undermine drug development and public health.
Circumventing the drug approval process created by Congress could upend the pharmaceutical industry and chill research and development, with dire consequences, they said.
"Patients who rely on medications for their health and well-being could see their drugs removed from the market," the experts warned.
The food and drug law scholars are represented by Lewis A. Grossman, Denise Esposito, Robert A. Long, Julia F. Post, Beth Braiterman and Emile Katz of Covington & Burling LLP.
The ex-FDA officials are represented by Jordan D. Segall and Jerry Yan of Munger Tolles & Olson LLP.
Danco is represented by Jessica L. Ellsworth, Catherine E. Stetson, Philip Katz, Lynn W. Mehler, Kaitlyn A. Golden, Danielle D. Stempel, Marlan Golden, Delia Scoville and Eva M. Schifini of Hogan Lovells.
The DOJ is represented by Elizabeth B. Prelogar of the DOJ.
The anti-abortion groups are represented by Erik C. Baptist and Erin M. Hawley of the Alliance Defending Freedom.
The cases are Danco Laboratories LLC v. Alliance for Hippocratic Medicine et al., case number 22A901, and U.S. Food and Drug Administration et al. v. Alliance for Hippocratic Medicine et al., case number 22A902, before the Supreme Court of the United States.