A federal appeals court ruling that invalidated the FDA’s approval of the abortion drug is lawless: The mifepristone case in AUSTIN, Texas
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.
By a 2-1 vote a panel of three judges narrowed for now a decision by a lower court judge in Texas that had completely blocked the FDA’s approval of the drug following a lawsuit by mifepristone’s opponents.
The order, issued by the US Fifth Circuit Court of Appeals, partly overruled last week’s decision by Judge Matthew Kacsmaryk of the Northern District of Texas invalidating the FDA’s approval of the pill in 2000. The FDA has been tasked with assessing the safety and efficacy of drugs.
The number of abortions in the United States has increased since the Supreme Court eliminated the right to abortion in June of 2002, according to a report by the society of family planning.
It is unclear if the Justice Department or the drug manufacturer, Danco Laboratories, will ask the Supreme Court to intervene at this point. The DOJ had said that it would go to the high court if the 5th Circuit didn’t act by Thursday.
The judges who voted to tighten restrictions were both appointees of Donald Trump. The third judge was named after former President George W. Bush. She said she would temporarily put the lower court ruling on hold to allow oral argument in the case.
The judge said she would have granted the expedited appeal but would have issued an administrative stay on Kacmsaryk’s ruling – a temporary hold that would have lasted a “brief period of time” – and deferred the question of whether it should be frozen longer term to the judges hearing the expedited appeal.
Otherwise, they wrote, “the district court’s lawless opinion will empower any plaintiff to grind drug approvals to a halt, disrupting patients’ access to critical medicines. That outcome would chill crucial research and development, undermine the viability of investments in this important sector, and wreak havoc on drug development and approval generally, causing widespread harm to patients, providers, and the entire pharmaceutical industry.”
David Cohen, a professor of law at the university, says that restrictions on the pill placed by the appeals court is just as troubling as Judge Kacsmaryk’s ruling. He says the courts are trying to influence how an already approved drug can be used. It is a lawless opinion without respect to the FDA.
A Motion to Redress the State of the Supreme Court’s Case against Mifepristone on the Evidence of Access Disruption
Mifepristone has been used by millions of women over the past 23 years, and complications from mifepristone occur at a lower rate than problems in wisdom teeth removal, colonoscopies and other routine procedures, medical groups have recently noted.
The experts predicted that the US Supreme Court’s decision would cause conflicts between states and the federal agency over certain policies for drugs, which would undermine the longstanding agreement that federal regulations should.
Massachusetts Gov. Maura Healey and Washington Gov. Jay Inslee have announced that their states have begun stockpiling mifepristone in the event that access is disrupted. New York Gov. Kathy Hochul and California’s Gov. Gavin Newsom both say that their states are storing huge amounts of the medicine.
The motion was filed by the Justice Department asking Rice to clarify the meaning of his ruling, since there appears to be tension with the nationwide injunction.
Higgs vs Hey Jane: Enforcing Mifepristone Without Allowing Misoprostol From Telemedicine Providers
There are back-up plans in place if mifepristone becomes unavailable for US telehealth providers. Medication abortions typically consist of two pills: mifepristone and misoprostol. The hormones progesterone and Mifepristone are needed for pregnancies to continue. In order for a fetus to be expelled from the body it requires the use of misoprostol, which is often referred to as the abortion pill. And as misoprostol is not subject to the recent rulings, there is a possibility that these companies will begin offering misoprostol on its own if manufacturers cut off access to mifepristone. The combination of pills is the best way to go, but it can also cause additional nausea and vomiting. It is better than nothing for providers who are determined to help patients.
The data of abortion providers nationwide is collected by the Society of Family Planning. More than 80% of providers the nonprofit identified participated in the analysis. Aid Access medication abortion is not included in the report because it is not part of the formal US healthcare system. However, a study from last November found that there were about 6,500 requests made per month to Aid Access for medication abortion.
These companies are moving fast to ensure they are able to operate legally even after more restrictions are imposed. As of now, both Hey Jane and Choix are continuing to offer mifepristone pills by mail in the states they were previously servicing.
Earlier this week, an open letter signed by more than 500 pharmaceutical executives and researchers declared that a decision to side with the conservative groups in curtailing access to mifepristone would result in “uncertainty for the entire biopharma industry.” Dr. Albert Bourla, the CEO of Pfizer is one of the executives who signed the letter.
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.
“Defendants have not shown that plaintiffs are unlikely to succeed on the merits of their timely challenges,” the three-judge panel wrote. The injunction will be taken effect this weekend, however there will be 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.
What the FDA has to do about vaccines and how it should be used to fight ectopic pregnancy: A case study of mifepristone
It is very difficult to bring new drugs to market. To research and develop a new medical product can cost hundreds of millions of dollars and years of clinical trials.
It’s not worth the risk of financial loss to invest in drugs that can be seen as politically controversial if an FDA approval can be revoked in part or in whole at any time by a judge.
Take vaccines as an example, said Allison Whelan, a law professor at Georgia State University. “This is essentially saying, ‘Here is a way that you could stop these vaccines that you disagree with,’ not for safety and efficacy reasons, but for other reasons,” she said.
There are concerns that the litigation could undermine the agency’s authority outside of the courts. There is skepticism about the FDA’s actions on the drug.
The pharmaceutical industry will be aggressive in lobbying Congress, and other measures, to preserve the FDA approval process, according to Harvard University’s Pankaj Sarpatwari. “I think that all cards are on the table in terms of what industry may do,” he said.
Dr. Joshua Sharfstein is a former deputy commissioner for the FDA and is currently the vice dean of the school of public health. The advisory committees were in full support of this. It was supported by major professional associations after millions of women received the treatment.
The drug was then approved in China, the United Kingdom and Sweden in the late 1980s and early 1990s. In 1999, more than a dozen countries approved the drug, which is called mifepristone.
The FDA went through three rounds of reviews over four years, each time issuing an “approvable” letter, meaning the safety and efficacy data was solid. The agency wanted to know more about manufacturing and instructions before approving it.
The part the agency used in the approval allowed it to add safety restrictions, such as requiring that physicians providing the pill be able to diagnose ectopic pregnancies.
“There are people who have wanted RU-486 to be pulled off the market since the day it was approved,” then-Rep. Henry Waxman, a Democrat from California, said at the time. They didn’t want it to be approved. They are very strongly against abortion regardless of the method, that’s why I respect their judgement. That isn’t an issue of safety or science, it’s an issue of data.
Wyoming by far recorded the highest rate of telehealth abortions both before and after the Dobbs ruling of any state. Before the ruling, 92% of abortions in Wyoming were provided via telehealth, and in the months following the decision, that rate dropped to about 80%.
The Supreme Court is expected to respond as soon as Friday to a formal request from the Justice Department to block a federal appeals court decision that limits access to the abortion drug mifepristone.
The FDA requested an immediate administrative stay to preserve their status quo while the court considers the request. Portions of a Texas district court’s order that limits the drug would otherwise take effect at 1:00 a.m. ET on Saturday, April 15.
The FDA’s approval of the drug in 2000 was challenged by anti-choice groups in Texas.
The DOJ appealed to the Supreme Court in order to ensure full access to the drug, because of the final ruling from the appellate panel.