Lawsuit seeks to reverse FDA’s ‘reckless’ approval of abortion pills
A lawsuit filed in federal court on Tuesday alleges that the Drug Enforcement Administration failed to require that an investigational drug used to end miscarriages be made available to women in the U.S., despite knowing that it wasn’t effective.
The lawsuit, filed by the Center for Reproductive Rights (CFRR), challenges the FDA’s approval of the mifepristone-misoprostol combination pill on grounds that the agency’s approval was “arbitrary, unreasonable, and unsupported by substantial evidence.”
“The FDA’s decision to approve a dangerous drug without providing information that would allow women to make an informed choice about whether to take it was not only reckless, it was criminally negligent,” states the lawsuit, which is filed under the federal Freedom of Information Act.
The FDA’s approval was in response to a petition from Bayer, which, in December, asked the FDA to approve the drug, which is currently used in the treatment of certain forms of miscarriage.
The drug is taken as a “night-time dose” to end a pregnancy once it has become “at least 5 mm.” As the drug’s action is dependent on prostaglandin levels, which are naturally present after a miscarriage, it is known as a “miscarriage-dissolving” drug.
The FDA, in its December 2017 approval, issued a conclusion that “the risk-benefit assessment favors approval of mifepristone and misoprostol for use in treating early pregnancy loss.”
But the FDA’s conclusion is largely based on unpublished results of a “high-dose” study that, according to the FDA, “did not show a clinically significant decrease in the live birth rate when compared
