And then interpret this as you will: in argui

in arguing that the IND submissions were not protected under the confidential commercial information exemption, Public Citizen contended that they should be released to determine whether the FDA was adequately protecting trial subjects and to allow competitors to avert potentially risky trials of related drugs. This argument, too, failed to convince the court, which held that the bulk of the IND material did fall within the scope of that exemption. The court further stated that the purpose of FOIA is merely to monitor "what the government is up to", and thus that any other benefits of disclosure are not relevant to analysis under that exemption. [24] In other words, the confidential commercial exemption does not authorize the courts to weigh the public interest in disclosure against the potential competitive harm that disclosure may cause. The court ordered the release of the one IND application for which it found that disclosure was not likely to cause substantial competitive harm, as required for protection under that exemption. [25]

In a similar, earlier case, Public Citizen sought records regarding preclinical and clinical testing of fialuridine, a drug that had caused the deaths of five patients in clinical trials for Hepatitis B infection at the National Institutes of Health. [26] Despite this striking toxicity, the drug's sponsor, Eli Lilly, claimed that it would continue to develop the drug. [27] The FDA and the drug's sponsor argued that the materials sought were subject to the confidential commercial information exemption. The court agreed, noting in an unreported decision that the records fell within the scope of that exemption because the information they contained might save Lilly's competitors both time and money in doing their own research. Again, under this ruling, such public health concerns as avoiding the exposure of clinical-trial subjects (or patients in general after the drug's approval) to drugs closely related to fialuridine were not factors in the FOIA analysis.

BMSN