Dozens of drugmakers and pharmaceutical executives are urging a federal appeals court to stay a ruling that invalidated the two-decades-old approval of an abortion drug, saying a Texas judge allowed personal conclusions and cherry-picked anecdotes to supplant scientific reasoning.
COVID-19 vaccine maker Pfizer and other companies said if the ruling is not overturned, it would set the table for a series of challenges that could “grind drug approvals to a halt.”
U.S. District Court Judge Matthew Kacsmaryk in Texas sided with pro-life groups last week in declaring the Food and Drug Administration’s approval process of the mifepristone drug was unlawful.
Judge Kacsmaryk said in his 67-page decision that the court “does not second-guess FDA’s decision-making lightly.”
“But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions,” said the judge, a Trump appointee who sits on the federal court in Amarillo, Texas.
Top drugmakers slammed the ruling as a grave threat to the scientific drug-approval process.
“The district court unreasonably found fault with FDA’s sound scientific judgments in order to stay approval of a drug that has been approved for nearly a quarter-century and used safely by millions of women,” the drugmakers told the U.S. Court of Appeals for the 5th Circuit in a brief filed late Tuesday and circulated by the White House on Wednesday. “Far from being limited to one drug, the logic of the district court’s order overturns the long-settled legal basis of FDA’s drug-approval process. Unless stayed, the district court’s lawless opinion will empower any plaintiff to grind drug approvals to a halt, disrupting patients’ access to critical medicines.”
The Texas decision conflicted with a ruling from Washington state on the same issue, leading to confusion. The Justice Department is seeking a stay of the Texas decision before it goes into effect this week, prompting a series of briefs from stakeholders on both sides of the issue.
Scores of Democrats signed onto an amicus brief urging the appeals court to hit pause on the Texas ruling while over 60 congressional Republicans urged the court to keep the ruling in place.
The drugmakers said if the Texas decision is allowed to stand and becomes precedent, it will “chill crucial research and development” in the pharmaceutical sector and “wreak havoc on drug development and approval generally.”
The brief effectively puts pharmaceuticals on the same side as President Biden in the fight, even though the president has boasted about recent victories over Big Pharma, including legislation that let Medicare negotiate down the price of certain drugs for the first time.
Experts say it’s unclear whether mifepristone will be yanked from the market if the Texas ruling goes into effect. The FDA could, for instance, say it has enforcement discretion and not go after pharmacists who distribute the drug.
New York City Mayor Eric Adams, a Democrat, said Wednesday he filed a brief with cities and counties in California, Washington and Illinois seeking a stay of the Texas ruling.
“If the safe and effective two-drug regimen is suddenly removed, our public health care system will have to divert resources to provide alternate options and procedures, which will undoubtedly affect our public hospitals’ ability to provide care to patients seeking abortions and could impact their ability to provide care across the board,” Mr. Adams said.
On the anti-pill side, Republican lawmakers wrote in court documents they are “committed to protecting women and girls from the harms of the abortion industry.”
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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