By Christina Jewett and Pam Belluck
A federal judge’s ruling to revoke the Food and Drug Administration’s long-standing approval of the abortion pill mifepristone poses threats to the U.S. government’s regulatory authority that could go far beyond one drug, legal experts say.
The decision by a Texas judge appears to be the first time a court has moved toward ordering removal of an approved drug from the market over the objection of the FDA.
If the initial ruling, a preliminary injunction issued Friday, withstood appeals, it could open the door to lawsuits to contest approvals or regulatory decisions related to other medications. And if upheld, the Texas decision would shake the very framework of the pharmaceutical industry’s reliance on the FDA’s pathways for developing new drugs, legal experts said.
“This is a frontal assault on the legitimacy of the FDA and their discretion to make science-based decisions and gold standard approval processes,” said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University. “It ultimately takes us on an extraordinarily dangerous path for FDA as an agency, and for science-based public health decision-making more broadly.”
In the Food, Drug and Cosmetic Act of 1938, Congress gave the FDA overarching authority to determine whether drugs are safe and effective. Drug companies must conduct a series of animal studies and human clinical trials that can take years and millions of dollars to provide enough evidence to the agency that a drug is a safe and effective treatment for a disease or a medical condition.
For nearly a century, courts have usually deferred to the federal agency’s scientific expertise and oversight. Yet, the use and approval of a wide array of medications have increasingly become the focus of political rifts and state-level disputes over such disparate issues as the opioid crisis, COVID-19 vaccines and gender-related treatments.
Now, the ruling in the Texas case and a contradictory ruling the same day by another federal judge in a separate case in Washington state have thrust the issue of FDA authority into the spotlight as never before, and the issue is almost certain to land before the Supreme Court.
“If this ruling were to stand, then there will be virtually no prescription approved by the FDA that would be safe from these kinds of political, ideological attacks,” President Joe Biden said in a statement Friday night about the Texas decision.
The powerful pharmaceutical industry has not officially weighed in on the Texas ruling or indicated whether it will file briefs in support of the FDA. In a statement, Priscilla VanderVeer, vice president of public affairs for Pharmaceutical Research and Manufacturers of America, or PhRMA, echoed others in referring to the FDA as the gold standard for drug approvals.
“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,” VanderVeer said.
Mifepristone is the first pill in the two-drug medication abortion regimen.
The plaintiffs in the Texas lawsuit are also targeting the second drug, misoprostol, which is approved for other medical conditions but used off-label for abortion. A spokesperson for Pfizer, which makes a small percentage of the misoprostol sold in the United States, said it did not support off-label use of any of its medicines and declined to comment about whether the company would submit a court brief supporting the FDA.
But she said that “the agency serves a critical role in the U.S. public health system — bringing new medicines to patients and conducting ongoing safety reviews that support the continued use of them — that must be maintained.”
In the Texas case, which was filed by a consortium of anti-abortion groups, the judge, Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas, declared the FDA’s approval of mifepristone in 2000 to be invalid. Kacsmaryk, who has affiliations with conservative Christian organizations and has written critically of Roe v. Wade, stayed his injunction for seven days to allow the FDA to appeal to a higher court. So, for now, mifepristone remains available.
In the Washington state case, Democratic attorneys general from 17 states and the District of Columbia challenged extra restrictions that the FDA imposes on mifepristone. In a preliminary injunction, Judge Thomas Rice of the U.S. District Court for the Eastern District of Washington ordered the FDA not to limit the drug’s availability in those jurisdictions, which make up a majority of the states where abortion remains legal.
The Justice Department, which is representing the FDA, immediately said it would appeal the Texas injunction to the 5th U.S. Circuit Court of Appeals.
In response to the Texas ruling, the FDA said its “approval was based on the best available science and done in accordance with the laws that govern our work.”
The agency added: “FDA stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to FDA-approved medications.”
Upending the FDA’s authority could be disruptive to the U.S. pharmaceutical industry, which banks on a yearslong window of drug sales as it funds the risky and expensive process of drug discovery, said I. Glenn Cohen, a Harvard Law School professor and bioethics expert.
“If your approval can be withdrawn at a moment’s notice by a single judge,” said Cohen, an author of a brief supporting the FDA, “it’s really kind of a scary thing.”