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Access to the most commonly used abortion method in the US is plunged into uncertainty after conflicting court rulings over the legality of the abortion drug mifepristone, which has been available for more than 20 years.
For now, the drug, which was approved by the Food and Drug Administration (FDA) in 2000, remains largely unavailable because of separate rulings issued just minutes apart by federal judges in Texas and Washington.
U.S. District Judge Matthew Kaczmaryk, a Trump appointee, ordered federal approval of mifepristone in a ruling that defied decades of scientific consensus. But the decision was quickly followed by US District Judge Thomas O. Rice, an Obama appointee, essentially the opposite and directing US authorities not to make many changes that would limit access to the drug.
The extraordinary timing of the competing orders revealed the high stakes surrounding the drug a year after the US Supreme Court overturned Roe v. Wade and curtailed access to abortion across the country.
“The FDA is in one order that says you can’t do anything and another that says within seven days, I’m going to ask you to drop the approval of mifepristone,” said Glenn Cohen of Harvard Law School.
A conservative Texas judge is now weighing arguments in a case that could ban the widely used mifepristone abortion bill in the United States. Last November, a coalition of anti-abortion groups filed a lawsuit to overturn federal approval of the pill.
The immediate impact of the decision by Kacsmaryk, which is not immediately applicable, is unclear.
Abortion drugs have been widely used in the US since 2000 and there is no precedent for a single judge overruling a medical decision from the Food and Drug Administration. Mifepristone is one of two drugs used for medical abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.
Kacsmaryk, a Trump administration appointee in Amarillo, Texas, signed an injunction directing the FDA to keep mifepristone approved while lawsuits challenging the drug’s safety and approval continue. The 67-page order gave the government seven days to appeal.
“Simply, the FDA’s judicial review is stonewalled — until now,” Kacsmaryk wrote.
They did not go as far as the plaintiffs wanted by revoking or suspending the approval of chemical abortion drugs and removing them from the list of approved drugs. But they “stay” or continue to have the drug approved.
A federal attorney representing the FDA was requested to do so immediately.
Mifepristone is part of the two-drug regimen that has long been the standard for medication abortions in the US
Clinics and doctors who prescribe the combination of the two drugs say that if mifepristone is withdrawn from the market, they will only use another drug, misoprostol. The single-drug approach has a relatively low rate of effectiveness in terminating pregnancy, but is commonly used in countries where mifepristone is illegal or unavailable.
The lawsuit was filed by the Alliance Defending Freedom, which also participated in the Mississippi case that led to Roe v. Wade being overturned. At the heart of the lawsuit are allegations that the FDA’s initial approval of mifepristone was flawed because it did not review safety risks.
Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment where abortion is prohibited or unavailable in 14 states, while 16 states have specific laws for abortion drugs.
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