The Trump administration has approved a generic version of the abortion pill mifepristone, despite Health Secretary Robert F Kennedy Jr ordering a review into the drug’s safety.
The drug will now be produced by Evita Solutions LLC, which describes its mission as being to “normalize abortion” and make it “accessible to all.” The company received approval from the FDA on Tuesday.
“We have completed the review of this ANDA [abbreviated new drug application] and have concluded that adequate information has been presented to demonstrate that the drug meets the requirements for approval under the FD&C Act,” the FDA wrote. “Accordingly the ANDA is approved.”
Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, described the “reckless” decision by the FDA to expand the availability of abortion drugs as “unconscionable.”
“These dangerous drugs take the lives of unborn children, place women and underage girls at serious risk, empower abusers, and trample the pro-life laws enacted by states across the nation,” Dannenfelser said in a statement Thursday.
Dozens of peer-reviewed studies have found that fewer than 0.5 percent of patients who take mifepristone have serious adverse reactions, and it has been approved by the FDA and widely used for over 20 years.
However, earlier this year, a dubious report from anti-abortion activists attempted to cast doubt on the safety of the drug.
In the report, the Ethics and Public Policy Center, a right-wing think tank, claimed that serious complications from mifepristone use were 22 times higher than previously reported and called on the FDA to “reconsider its approval altogether.”
Despite the report being condemned by pro-abortion advocates and public health officials as unscientific and politically motivated, Kennedy and Trump-appointed FDA commissioner, Marty Makary, have said they will reexamine the safety of mifepristone.
Makary had said previously he had no plans to change the government’s position on mifepristone unless new data discovered a safety concern.
Missouri Republican Sen. Josh Hawley, whose wife, Erin Hawley, is a senior counsel with the right-wing legal advocacy group Alliance Defending Freedom, was one of those who called on Makary to “follow this new data.”
Hawley expressed outrage Thursday following the announcement of the FDA’s decision, describing it as “shocking.”
“FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother. And of course 100% lethal to the child,” he wrote.
“FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution. I have lost confidence in the leadership at FDA.”
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Meanwhile, on Wednesday, anti-abortion District Judge Matthew Kacsmaryk — whose court ruling on mifepristone triggered a Supreme Court battle — ruled to transfer a case that challenges the FDA’s approval of the drug to a court in Missouri, which is packed with Trump appointees.
“We are disappointed that the court failed to rule today on our motion to dismiss, allowing this politically motivated case to continue to proceed,” said Evan Masingill, CEO of GenBioPro, the company at the center of the case, which also has approval to manufacture the drug.
“Mifepristone has been approved by the FDA for a quarter century using their rigorous standards. Any attempt to roll back access to mifepristone infringes on Americans’ reproductive freedom and will jeopardize the health of millions nationwide.
“GenBioPro remains committed to ensuring affordable, science-based access to medication abortion for all who need it.”
