Public Citizen, National Women's Health Network v. Department of Health and Human Services

JUDGMENT

This cause came on to be heard on the record on appeal from the United States District Court for the District of Columbia and was argued by counsel.

On September 12, 1980, after a six-year period of meetings and research, the Food and Drug Administration (“FDA”) published final regulations requiring “patient package inserts” (“inserts”) to be given out with ten widely used drugs, which are dis*519tributed only to patients on prescriptions by doctors. 45 Fed.Reg. 60754 (Sept. 12,1980). The FDA has previously required inserts for five drugs and devices, and its authority to do so for…