April 11, 2023


“A U.S. judge in Texas on Friday suspended the two-decade-old approval of the abortion pill mifepristone while a legal challenge proceeds… The case was brought by four anti-abortion groups headed by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors who sued the FDA in November. They contend the agency used an improper process when it approved mifepristone in 2000 and did not adequately consider the drug's safety when used by girls under age 18 to terminate a pregnancy.” Reuters

Many on both sides are skeptical of the legal reasoning behind the decision:

“Judge Kacsmaryk’s reasoning, if it can be called that, appears more rooted in ideology than in law… [The opinion] seizes on dubious studies by antiabortion activists to declare that the FDA has ignored the safety risks of what they claim is a manifestly unsafe medication. Really, the opposite is true. The FDA regulates mifepristone with a special framework of restrictions reserved for only 60 drugs in the country, and through multiple reviews it has determined that the pill is, indeed, very safe to use — with complications occurring in fewer than 1 percent of cases… 

“Supporters of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization to overturn Roe v. Wade claimed the ruling merely put the abortion question in the hands of individual states. So much for that. Judge Kacsmaryk’s decision marks the first time a court has dictated a drug be removed from the market over the FDA’s objection. If it stands, women won’t be able to choose to have medication abortions, and states won’t have the right to let them.”

Editorial Board, Washington Post

“[Kacsmaryk’s] legal mistake is overstepping his authority as a judge to conduct his own review of the abortion drug’s risks and benefits. Congress has delegated such technical questions to regulatory agencies. It’s not the role of judges to redo an agency analysis… 

“But Democrats don’t seem bothered when liberal judges do this to invalidate environmental reviews on fossil-fuel projects. And they cheered when federal Judge Thomas Rice, an Obama appointee, on Friday disagreed with the FDA’s safety restrictions on mifepristone… Abortion policy should be set by the people and their representatives, not by judges. If higher courts overrule Judge Kacsmaryk on appeal, this will likely be the reason. And let’s see if the legal eagles on the left give them due credit for intellectual consistency.”

Editorial Board, Wall Street Journal

Other opinions below.

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From the Right

From the Left

“Perhaps most disturbingly, Kacsmyrak's order invokes the long-dormant Comstock Act, used copiously in the Victorian era to prevent people from mailing information about birth control, among other things. The Comstock Act originally banned the mailing of ‘lewd’ writings, contraceptives, and any ‘instrument, substance, drug, medicine, or thing’ that could trigger an abortion, though Congress struck the reference to contraceptives from the law in the 1970s… 

“If upheld, Kacsmaryk's order would not only undo a number of recent FDA decisions with regard to the mailing of mifepristone but could pave the way for a Comstock Act enforcement revival.”

Elizabeth Nolan Brown, Reason

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