Celebrex information disclosure

FDA must release to Public Citizen's Health Research Group the raw patient data in Searle's Celebrex advisory committee packet, following a Jan. 19 summary judgement by Washington D.C. federal court Judge James Robertson that the information is not covered by Freedom of Information Act exemptions. HRG's request for release of names of Searle's scientific investigators and titles of unpublished articles by Searle investigators submitted to FDA was denied. Public disclosure of advisory committee materials was mandated under a July settlement with HRG, though the agency may redact material it considers confidential (1"The Pink Sheet" Jan. 3, p. 21)

FDA must release to Public Citizen's Health Research Group the raw patient data in Searle's Celebrex advisory committee packet, following a Jan. 19 summary judgement by Washington D.C. federal court Judge James Robertson that the information is not covered by Freedom of Information Act exemptions. HRG's request for release of names of Searle's scientific investigators and titles of unpublished articles by Searle investigators submitted to FDA was denied. Public disclosure of advisory committee materials was mandated under a July settlement with HRG, though the agency may redact material it considers confidential (¹ (Also see "Advisory Cmte. Package Redaction Could Add Two Months To Priority Review" - Pink Sheet, 3 Jan, 2000.)).