The Case against Mifepristone: Biden’s First-Law Order, Danco Laboratories, and the 5th Circuit Court of Appeals
Regardless of how the appeals court rules, though, there is certain to be an appeal from the Biden administration, on behalf of the FDA, and Danco Laboratories, maker of the leading brand of mifepristone, Mifeprex. In briefs already filed, they note that medical abortions using pills account for the majority of abortions in the U.S. today. And they cite dozens of studies and clinical trials showing that the drug is exceedingly safe for use up to 10 weeks into pregnancy.
But the justices, for now, left the case in the hands of the 5th U.S. Circuit Court of Appeals, which has scheduled oral arguments in the case for May 17. However the 5th Circuit rules, the case will almost certainly end up back at the Supreme Court, with the potential for a decision in the case next term.
The drug will be widely available if abortion is legal for 10 weeks into a pregnant woman’s life in some states.
In his dissent, Alito argued, “As narrowed by the Court of Appeals, the stay that would apply if we failed to broaden it would not remove mifepristone from the market. The circumstances existed under three presidential administrations, and it would simply restore them.
“I continue to stand by FDA’s evidence-based approval of mifepristone, and my Administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs,” Biden said in a statement.
“The stakes could not be higher for women across America. I will continue to fight politically-driven attacks on women’s health. The people of the United States must continue to use their votes, and Congress must pass a law restoring the protections of the abortion law, according to Biden.
After the oral arguments in the case, it is not likely that the court will make a change in its view. Its 42-page preliminary order is based, in part, on the Comstock Act, a law that for generations has not been enforced. Enacted in 1873, the statute sought to prevent the mailing of obscene or lewd materials and to bar the mailing of any substance, article or drug used for birth control or for the purpose of “unlawful abortion.”
The FDA and Danco believe that if the 5th Circuit’s decision to become law were to happen, there would beregulatory chaos across the country. Danco’s brief said that the result would be “anuntold limbo” for Danco and the FDA, as well as doctors, health care systems and women who use drugs when they miscarry.
The manufacturer of a generic form of the drug Mifepristone is in a legal battle with the FDA. If mifepristone was revoked, the generic version of Gen Bio Pro would also be suspended. The company alleges that if the FDA complies with Kacsmaryk’s ruling, it would violate the established legal process for withdrawing a previously approved drug from use.
Ameet has been an assistant professor of medicine at Harvard Medical School and is a lawyer. The established process was circumvented by Kacsmaryk’s ruling. The FDA and the manufacturers have removed drugs from the market in the past but a court has never stepped in to remove a long-approved drug from use.