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Executive Summary

FELDENE SUMMARY NDA DATA WILL BE DISCLOSED, FDA told Pfizer attorney William Vodra (D.C. firm Arnold & Porter) in a June 27 letter. FDA Associate Commissioner for Public Affairs Jack Martin stated: "We do not agree that to be considered 'summary,' data must be presented so generally as to be of no assistance in evaluating the safety or effectiveness of a drug. Data may be presented in sufficient detail to allow for evaluation and analysis, yet still be considered 'summary' for purposes of deciding whether they may be disclosed" under Freedom of Information. He said that in his judgment "the data at issue are not so detailed as to be considered something other than a summary of safety and effectiveness data." FDA's letter responded to a Pfizer petition requesting that FDA reconsider its decision allowing public access to certain data submitted to the Feldene NDA in March. Pfizer maintained that the information FDA regarded as publicly releasable summary data could allow competing firms to obtain regulatory approval of identical compounds in foreign countries. FDA reiterated that the information Pfizer seeks to withhold "is presented in summary fashion and is of the type routinely disclosed in accordance with FDA's Freedom of Information Act (FoI) regulations." Indeed, the agency stated, "many of the summaries in question are described under headings bearing the word 'studies,' and merely aggregate summaries of data from more than one study and do not reflect the result of one study or provide raw data on individual patients." The agency asserted that "the summary data Pfizer has submitted cannot be disaggregated to reveal individual study data" and is therefore not exempt from disclosure. FDA further stated that whether or not a record is exempt from disclosure under Exemption 4 of the FoI Act "depends on whether there is a showing of substantial harm to the competitive position of the person from whom the information is being obtained." FDA said Pfizer's claims "do not meet this standard."

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