Suffering its second setback, the Center for Responsible Science (CRS) lost its legal case demanding the U.S. Food and Drug Administration (FDA) add three additional disclosures to informed consent requirements via FDA Article III requirements.
CRS filed a one-count complaint under the Administrative Procedure Act against FDA Commissioner Scott Gottlieb, asking the court to require what CRS could not convince the agency to adopt, according to the final ruling issued by the United States District Court for the District of Columbia.
“The threshold question—and the one that ultimately trips Plaintiff up—is whether it can invoke this Court’s jurisdiction,” the court wrote in its October 22 ruling. “Once before, this Court found that CRS had failed to sufficiently demonstrate Article III standing but sent it back to the drawing board instead of dismissing the case. CRS now returns with added detail. Its Amended Complaint, however, still falls short of establishing the organizational injury necessary for this suit to continue.”
FDA’s current guidelines for informed consent in clinical trials cover a number of areas, including ensuring the potential patients understands they:
- may not benefit from the clinical trial;
- may be exposed to unknown risks; and
- are entering into a study that may be very different from the standard medical practices that they currently know.
Further, patients must demonstrate that they understand what will be done to them, how the protocol (plan of research) works, what risks or discomforts they may experience, and that their participation is a voluntary decision.
Author: Michael Causey