The recent ruling from U.S. district Judge Matthew Kacsmaryk, that the Food and Drug Administration improperly approved the abortion pill mifepristone, sets troubling precedents.

First, why does Judge Kacsmaryk feel that he has the medical expertise to overrule the decision made by the scientists and doctors on the various boards that originally authorized the drug’s approval more than 20 years ago? Most of Kacsmaryk’s arguments appeared to mirror those put forth by the anti-abortion movement and disregard the current scientific consensus. Judge Kacsmaryk did not cite any data showing that the FDA’s decision might be flawed. According to the New York Times, “more than 99% of patients who took the pills had no serious complications.”

Second, if courts can overturn FDA approvals without showing any compelling scientific or statistical evidence, then what stops a judge from blocking any new drug approvals on reasoning based on some political ideology instead of science? Suppose a lawsuit was brought during the recent COVID-19 pandemic seeking to block the distribution of either Moderna’s or Pfizer’s vaccines after they had gone through the FDA approval process. Granted, the approval timeline for these vaccines was accelerated in order to stop the spread of the virus as soon as possible. If the distribution of these vaccines were held up for months or years by legal litigation, the cost in the number of lives lost and human suffering would be immense.

Judges should base their decisions on jurisprudence and evidence, not political ideology.

Samuel Rosenthal
Portland

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