
Last Thursday, Judge Matthew J. Kacsmaryk ordered the Food and Drug Administration (FDA) to pull the abortifacient mifepristone from the market after 23 years of generally safe and effective market access. The opinion's activist tone and questionable reasoning have been discussed ad nauseam, but one tidbit has been missing: Kacsmaryk demanded an unprecedented degree of federal intervention in medical regulation.
Commerce Clause case law has drawn a fine line between federal regulation of medical devices —which Congress generally can regulate—and regulation of medical practices—which Congress cannot. The Constitution vests authority in Congress "to regulate Commerce…among the several States," and the Supreme Court is deferential to Congress' choices so long as Congress meets some minimum requirements. Under current case law, even "purely local" activities like growing wheat for home consumption may be reached by Congress if the aggregate effect of all home wheat farming "substantially affects" interstate commerce.