Center for Responsible Science v. Gottlieb

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA CENTER FOR RESPONSIBLE SCIENCE, Plaintiff, v. Civil Action No. 17-2198 (JEB) SCOTT GOTTLIEB, Defendant. MEMORANDUM OPINION Before a new pharmaceutical drug can come to market, testing must prove it to be both safe and effective. Plaintiff Center for Responsible Science believes that the Food and Drug Administration’s informed-consent regulation governing these initial human tests does not sufficiently warn participants of the dangers they face. CRS thus proposed that the FDA amend its regulation to add three additional disclosures, but…