Public Citizen HRG v. FDA (Bextra)

The manufacturer of the drug Bextra sought FDA approval to market Bextra for four uses. The FDA approved three uses, but denied the application to market the drug as an acute pain medication. When the FDA later released documents related to its evaluation of the drug’s safety and effectiveness, it withheld the parts of its medical officer’s review that addressed acute pain. Public Citizen’s Health Research Group made a FOIA request for this withheld information, which is particularly important because the drug is currently being prescribed for this unapproved use. After we sued, the FDA released to us the majority of the relevant information that it had withheld, and the case was resolved without litigation.