The Supreme Court of Texas Oblated the Order to Remain for Medication Abortion based on the High Court’s Misguided Assessment of the Drug’s Safety
AUSTIN, Texas — A federal appeals court has preserved access to an abortion drug for now but under tighter rules that would allow the drug only to be dispensed up to seven weeks, not 10, and not by mail.
The Department of Justice asked the Fifth Circuit for a stay of Kacsmaryk’s decision while they heard the case. In their request, Justice Department lawyers argued that “the district court upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety.”
The FDA approved one of the two drugs used in a two step medication abortion but on April 8th a ruling from the northern district of texas invalidated that approval. The ruling ignored decades of scientific consensus about mifepristone’s safety, and undermined the FDA’s decades-old approval of the medication. It was directly conflicting with a ruling made by Judge Thomas Rice in the Eastern District of Washington, instructing US authorities to preserve access to the medication.
Medication abortion has emerged a particularly heated flashpoint in the abortion legal battle since the Supreme Court last year overturned the Roe v. Wade precedent that protected abortion rights nationally.
The Supreme Court may or may not be asked to intervene by the Justice Department and the drug manufacturer, Danco Laboratories. If the 5th Circuit did not act by noon on Thursday, then the DOJ was going to go to the high court.
The judges who voted for the tighter restrictions are appointees of Donald Trump. The third judge is an appointment of the former president. She said that she would have put the ruling on hold until the arguments could be heard.
The decision was deferred to the judges hearing the case, as to whether to grant the expedited appeal but issue an administrative stay on the ruling for a brief period of time.
Why the U.S. Supreme Court Affirmed Roe v. Wade in 2022 and Why Telemedicine Cannot Be Available Without Abortion
The plaintiffs argued that the FDA based its original decision on “transparently false conclusions” about the drug’s benefits and risks. They said the FDA failed to satisfy them. When it expanded the access to the drug, it had rigorous scientific standards.
The lower court’s decision was “alarming” and the Pharmaceutical Research and Manufacturers of America called it that on Wednesday.
Several major medical organizations, including the American Medical Association, say that mifepristone is safe and have urged courts to preserve access.
Since it became clear in 2022 that the US Supreme Court would overturn Roe v. Wade, experts have predicted that conflicts would arise between states and the federal agency over which drugs are allowed in which states, and if they can be shipped there by mail—thus undermining the longstanding agreement that federal regulations should supersede the wishes of individual states.
Washington state’s attorney general, Bob Ferguson, told NPR that he believes it will preserve access to the drug unless a higher court says otherwise.
The Justice Department made a motion Monday asking Rice to clarify the meaning of his ruling, because there appears to be tension with Kacsmaryk’s nationwide injunction.
With access to the drug uncertain, some states have stocked up on mifepristone, along with the second drug in the two-pill regimen, misoprostol. Misoprostol is commonly used outside of the U.S. as the sole drug in medication abortions.
The Justice Department asked the Supreme court to block the appeals court’s decision limiting access to abortion drugs.
The Fifth Circuit’s decision drew rebuke from Vice President Kamala Harris on Tuesday. It “second-guesses the agency’s medical experts,” she said. “If this decision stands, no medication — from chemotherapy drugs, to asthma medicine, to blood pressure pills, to insulin — would be safe from attacks.”
Late Wednesday night, just before midnight Eastern Time, the appellate panel issued a complicated ruling on the injunction, siding in part with the FDA and part with the anti-abortion coalition.
This reversal impacts a wide network of telehealth providers. When FDA loosened restrictions around abortion care, abortion pills became available in twenty-five states and Washington DC by mail. Many of these pills were supplied by services devoted to reproductive telemedicine like Hey Jane and Choix.
These companies have been preparing for increased restrictions, and are now moving quickly to ensure they’re still able to legally operate without pause. As of now, both Hey Jane and Choix are continuing to offer mifepristone pills by mail in the states they were previously servicing.
A group of pharmaceutical executives and researchers wrote an open letter earlier this week, saying that a decision to side with the conservative groups would result in uncertainty for the entire biopharma industry. Among the signatories were Dr. Albert Bourla, the CEO of Pfizer, and executives from industry giants Bayer and Merck.
As the lawsuit was being considered in the lower court, PhRMA and other industry representatives had largely stayed on the sidelines, declining to file amicus briefs outlining the industry’s concerns even as other major medical groups, like the American Medical Association, weighed in.
The panel said defendants had not shown that the clients were unlikely to succeed on their merits. The injunction will take Effect this Weekend, barring an emergency intervention by the Supreme Court.
“Industry members are wondering, well, if a judge can do that, what else can’t a judge, perhaps with an ax to grind, do?” he said in an interview with NPR’s Morning Edition before the appeals court ruled.
The FDA’s Decision to revoke its approval is a political issue, and why we’re worried about a product that’s wrong with the FDA
New drugs are costly and time-Consuming to market. It takes hundreds of millions of dollars to research and develop a new medical product.
Companies may decide not to invest in drugs that could be seen as politically controversial if the FDA’s approval is revoked in part or whole at any time by a judge.
Take vaccines as an example, said Allison Whelan, a law professor at Georgia State University. She said it’s not for safety and efficacy reasons, but for other reasons, and that this is a way that you could stop the vaccines you don’t like.
The litigation could become a competitive tool. A rival’s product could be kept off the market if they disagree with the FDA’s decisions about a drug, she said.
The pharmaceutical industry should be aggressive in lobbying Congress and taking other steps to preserve the FDA approval process, said Harvard’s Sarpatwari. “There are a lot of options on the table, and I believe that all the cards are on the table,” he said.
A former deputy commissioner of the FDA who is now a vice dean says that it’s not credible. “This had the full support of advisory committees. It had the full support of major professional associations, and it retained that support after millions of women have received the treatment.”
The drug was then approved in China, the United Kingdom and Sweden in the late 1980s and early 1990s. In 1999, many more countries approved the drug.
“If there is a problem with this medicine then there’s a problem with many, many other medicines,” Sharfstein says. “Because this is very much in line with what FDA does and has the full support of the medical community.”
The part the agency used allowed it to include safety restrictions, such as requiring physicians that prescribe the pill to be able to diagnose ectopic pregnancies.
“Many people feel that it’s important to get rid of this drug since it was approved,” said Henry Waxman, Democrat from California, at the time. “In fact, they didn’t want it to be approved. I respect their judgment because they are very strongly against an abortion, whether it be by RU-486 or by a medical procedure. That isn’t an issue of safety, it is an issue of science, and it is not an issue of data.
Appealing the Food and Drug Administration of a Decision to Sufficiently Restrict Abortion with the U.S. Supreme Court
The FDA requested an immediate administrative stay in order to preserve the status quo while the court considers the request. On Saturday, April 15, portions of a Texas district court’s order limiting the drug would take effect.
Anti-Abortion groups in Texas filed a lawsuit against the Food and Drug Administration’s approval of a drug which is used to induce abortion in 2000.
The final ruling from the appellate panel led the DOJ to appeal to the Supreme court in hopes of restoring full access to the drug.
Supreme Court Justice Samuel Alito on Friday extended a hold on a lower court ruling that would have imposed restrictions on access to an abortion drug, a temporary move meant to give the justices more time to consider the issue.
She highlighted a key threshold issue in the case, arguing that the doctors opposed to abortion who are behind the suit do not have the legal right to be in court. She explained that they do not take or prescribe the drug and that the FDA approval did not require them to do anything.
The FDA regime around the drug used to be much stricter than it is now, which prevents patients who obtained it through telehealth or virtual visits from being mailed the pill in person.
The Fifth Circuit decision that the Department of Justice is appealing has been given to all parties until noon on April 18 to submit their responses.
On Thursday, April 13, US Attorney General Merrick Garland said the Justice Department sought “emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.” The department filed its appeal with the Supreme Court Friday morning.