Hoffmann-La Roche, Inc. v. Harris

MEMORANDUM

OBERDORFER, District Judge:

Plaintiffs are two leading manufacturers of pharmaceutical drugs and the Pharmaceutical Manufacturers’ Association (PMA). * They sue the Food and Drug Administration (FDA) of the Department of Health and Welfare to prevent FDA from approving any application by a competing drug manufacturer for the right to market a generic version of a drug previously approved by FDA, unless the competing applicant has filed reports of clinical tests of that drug and the “raw data” underlying those tests is available to the FDA. Intervenor Internal Medications, Inc. (IMS),…