As the nation awaits the final outcome of two federal cases — one in Texas and one in Washington state — involving the abortion drug mifepristone (Mifeprex), legal observers are raising the possibility that the Texas case could have repercussions beyond that single drug.
“As monumental as the effects will be for abortion and miscarriage care, the implications of this case go far beyond that,” said Jennifer Dalven, JD, director of the Reproductive Freedom Project at the American Civil Liberties Union, on a call Monday sponsored by Planned Parenthood. “If the courts allow this, it will radically alter the process for approving drugs and will chill innovation and bringing new drugs to market. They will be in essence telling every fringe group with an opposition to a medication or vaccine, ‘just go find a politically aligned judge,’ who can then with a stroke of a pen deny Americans the ability to get the critical life-saving treatment they need. That possibility should have all of us very concerned.”
In the Texas case, Judge Matthew Kacsmaryk, of the U.S. District Court for the Northern District of Texas, ruled that mifepristone, which the FDA approved in 2000 through an accelerated approval process, should never have been approved and needs to be removed from the market; the judge stayed his decision for 7 days to allow the defendant — the federal government — time to appeal, although the Justice Department asked for that time period to be extended; the department later asked the Supreme Court to intervene in the case.
Meanwhile, in Washington state, Judge Thomas Rice, of the U.S. District Court for the Eastern District of Washington, ruled that the FDA should be prevented from “altering the status quo and rights as it relates to the availability of mifepristone.”
The Texas case also calls into question the legal definition of “standing,” or a plaintiff’s right to bring a case to court in the first place, said Nancy Northup, JD, president and CEO of the Center for Reproductive Rights. She noted that the group that filed the lawsuit, the Alliance for Hippocratic Medicine, is comprised of anti-abortion physicians who wouldn’t be treating patients with mifepristone. “Under Judge Kacsmaryk’s ruling, virtually anybody who opposes an FDA-approved drug could drag the agency into court to challenge their decision,” she said.
The case also is unique from a legal standpoint because rarely has anyone gone to court to try to overturn an FDA approval decision, William Schultz, JD, a former FDA deputy commissioner who is now in private practice, said on a different call with reporters Monday. “Until now, there has always been strong deference by the courts to FDA. Allowing the courts to do this kind of searching and overturn the FDA if the judge thinks the FDA was wrong … could allow virtually anyone to challenge any FDA decision with a good chance of succeeding.”
Chances of succeeding are good, he continued, “because any FDA drug approval involves hundreds of judgments by the agency. And if a court feels free just to kind of take a fresh look at each of those, there’s a chance that the court will find one of those FDA judgments is wrong.”
The decision, if it is allowed to stand, would also be destabilizing to the research and development of new medications, Northup said. “Allowing the FDA to exercise its evidence-based expertise … is crucial for advancing the public health. Judge Kacsmaryk has substituted his opinion for the expertise of the agency in what is required.” Such second-guessing of the agency “threatens to hobble the FDA’s ability to improve critical new medications and the ability of the pharmaceutical companies to bring new medications to market,” she added.
The biopharmaceutical industry agreed. “As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval,” the industry said in an open letter signed by hundreds of drug and biotech company CEOs. “Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.”
In addition, if the ruling is allowed to stand, it could open up an even wider possibility, said Joanna Wright, JD, an attorney in private practice in New York City, who has worked with the Center for Reproductive Rights. “This idea that courts can start to ignore standing analyses [and other issues] could go beyond even FDA decisions” to other approvals by other federal agencies, she said.
MedPage Today reached out to the American Association of Pro-Life Ob/Gyns — a “partnering organization” of the Alliance for Hippocratic Medicine — for comment, but they were unable to respond by press time.
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