THURSDAY, April 13, 2023 (HealthDay News) — A federal appeals court ruled Wednesday that the abortion pill mifepristone may remain available at this time. But the court judges added certain provisions to their decision: a block on sending the pill to patients as well as suspensions of other measures the federal government has taken recently to improve access to drugs.
The three-member panel partially canceled Judge Matthew Kacsmaryk decision in Texas last week that declared the 2000 U.S. Food and Drug Administration approval of mifepristone invalid.
Mifepristone is usually given as the first of two drugs used during a medical abortion.
The United States Department of Justice had filed its call of Texas’ decision on Monday. “If allowed to take effect, the court order would frustrate the scientific judgment of the FDA and seriously harm women, especially those for whom mifepristone is a medical or practical necessity,” the appeal said.
In his preliminary ruling filed Wednesday, the federal appeals court suggested that a statute of limitations bars any legal challenges to the FDA’s approval of mifepristone. The court also appeared to consider the government’s view that removing a long-approved drug from the market would have “significant public consequences”.
But he left in place parts of Kacsmaryk’s decision that reversed an easing of restrictions on mifepristone by the FDA in recent years. This includes a decision in 2016 to allow the drug to be used for 10 weeks of pregnancy instead of the first seven weeks, as well as a decision this year to allow retail pharmacies to dispense the pills.
The Justice Department is likely to appeal the latest order to the Supreme Court.
The battle over mifespristone was launched at the end of last week.
THE Texas Decision was quickly followed by a decision by the federal judge in Washington State Thomas Rice which ordered a halt to “any action aimed at removing mifepristone from the market or making the drug less available”.
The two opposing rulings suggest that any final decision on the availability of mifepristone, which is usually made at the same time as misoprostol, could end up in the Supreme Court.
THE Washington State Trial came from Democratic attorneys general challenging restrictions in place that made it difficult to obtain mifepristone.
The Texas ruling involves a lawsuit filed by a coalition of doctors and anti-abortion groups that sought to end the use of mifepristone, claiming that the FDA’s decision 23 years ago to approve the drug had been taken in haste and without due regard to its overall safety.
In his ruling, Kacsmaryk said “the court does not question [the] FDA decision making lightly. But here, the FDA acquiesced in its legitimate safety concerns — in violation of its legal duty — based on blatantly flawed reasoning and studies that did not support its conclusions. There is also evidence that the FDA has come under significant political pressure to back down from its proposed safety measures in order to better advance the policy the goal of increased “access” to chemical abortion.
In a statement released on Monday, President Joe Biden warned that Kacsmaryk’s decision could affect drugs beyond mifepristone and affect Americans nationwide.
“If this decision were to stand, then there would be virtually no prescription, approved by the FDA, that would be immune to these kinds of political and ideological attacks,” he said.
Biden added that the ruling “doesn’t just affect women in Texas — if upheld, it would prevent women in every state from accessing drugs, whether or not abortion is legal in a state.”
And in an open letter published on Monday, hundreds of pharmaceutical executives also weighed in on the decision, warning of the impact on their industry if the Texas order were to go into effect.
“If courts can overturn drug approvals without regard to science or evidence, or the complexity required to fully verify the safety and efficacy of new drugs, any drug risks having the same outcome as the mifepristone,” the letter reads..
Medical abortion now accounts for about half of all abortions in the United States. With the annulment of Roe v. Wade last June, obtaining mifepristone and misoprostol for medical abortion was seen as a viable option for women living in states affected by bans who may still want to have an abortion.
Mifeprostol works by suppressing a hormone needed for pregnancy to continue. The second drug, misoprostol, induces contractions similar to those seen in a miscarriage. In countries where mifepristone is difficult to obtain, medical abortions often involve the use of misoprostol alone, although experts believe that the effectiveness of misoprostol alone is lower than that of the combination of two drugs and that side effects such as nausea become more frequent.
Groups of doctors concerned
Reaction to last week’s Texas ruling from proponents and opponents of abortion rights was swift.
“”Mifepristone has been used safely and effectively for medical abortion for more than two decades,” Hoskins and Phipps said. “This safety and effectiveness are supported by strong, evidence-based clinical data and its use observed by millions of people with the support of clinicians, including obstetrician-gynecologists. Regardless of a judge’s opinion on this, mifepristone is a safe solution. , an effective part of comprehensive health care.”
“Today’s decision is clearly a transparent effort to make it harder for people to access medical abortion,” they added. “It will force people to turn to other means of accessing abortion care; it will force clinicians to prescribe less safe and less effective regimens for medical abortion; and it will inflict more harm on those who already struggle to access the reproductive health care they need, increasing health inequalities.”
The American Medical Association (AMA) issued a similar advisory statement.
“There is no evidence that people are harmed by having access to this safe and effective drug,” the AMA president said. Dr Jack Resneck Jr. “On the contrary, there is substantial evidence that the denial of necessary abortion care without justification takes a heavy psychological, physical and economic toll.”
Resneck added that any court decision to overturn the FDA’s approval of mifepristone could set a dangerous precedent for other drugs Americans use daily.
“This decision introduces the extraordinary and unprecedented danger that the courts will reverse long-standing regulatory decisions of the United States Food and Drug Administration. [FDA]. This goes against the established scientific process that leads to these decisions and puts other drugs at risk of being subjected to similar efforts,” he said.
In a statement published on friday Carole Tobiaspresident of National Right to Life, a group that opposes abortion access, supported Kacsmaryk’s decision.
“This decision highlights something the Biden administration wants to sweep under the rug – that these drugs do not treat or cure disease but kill unborn children and expose their mothers to dangerous side effects. The FDA should be about ensuring safety, not taking lives,” she said.
Danco Laboratories, one of the two companies that manufacture mifepristol, said it will fight to get its drug (Mifeprex) to women.
“Danco joined the case as a defendant to protect the availability of Mifeprex for pregnant women and the company’s only product, recognizing the importance of mifepristone as the only drug approved for medical abortion “, the company said in a statement. statement.
The company estimates that more than 5 million women have used Mifeprex for medical abortion since its approval in 2000, noting that it is 97% effective in terminating early pregnancy.
Even if the decision to rescind FDA approval for mifepristone is ultimately upheld, experts believe most American women could still have access to medical abortion, since misoprostol would remain legal.
SOURCES: White House, press release, April 7, 2023; American College of Obstetricians and Gynecologists, statement, April 7, 2023; American Medical Association, National Right to Life, statement, 7 April 2023; Danco Laboratories, press release, April 7, 2023