Citizens Commission on Human Rights v. Food and Drug Administration, and Eli Lilly and Company, Defendant-Intervenor-Appellee

Citizens Commission on Human Rights (“CCHR”) appeals the district court’s grant of summary judgment in favor of the Food and Drug Administration (“FDA”) and Eli Lilly and Company (“Lilly”). The district court rejected CCHR’s claims that the FDA did not adequately respond to its Freedom of Information Act (“FOIA”) request, 5 U.S.C. § 552 (1988), and that the agency improperly withheld responsive documents.

On appeal, CCHR contends that the district court erred in; (1) finding that the FDA’s search was responsive to CCHR’s request; (2) concluding that the FDA’s Vaughn Index was adequate; (3) entering summary judgment before allowing CCHR to conduct additional discovery; and (4) upholding the FDA’s decision to not disclose numerous responsive documents. We have jurisdiction pursuant to 28 U.S.C. § 1291 (1988), and we affirm in part and remand in part.

I. BACKGROUND

In order to obtain FDA approval for the marketing of a new drug, a pharmaceutical manufacturer must submit extensive data, including full reports of pre-clinieal and clinical investigations that demonstrate the drug’s safety and effectiveness for its intended use. Once the FDA has approved a new drug, the manufacturer…