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FDA COULD SHARE "CONFIDENTIAL" INFORMATION WITH FOREIGN GOVERNMENTS

Executive Summary

FDA COULD SHARE "CONFIDENTIAL" INFORMATION WITH FOREIGN GOVERNMENTS under a proposed amendment to the Freedom of Information Act detailed in the June 26 Federal Register. FDA is seeking comments on a proposal to remove restrictions on the disclosure of certain confidential commercial information to foreign governments. Comments will be accepted until Aug. 25. Commercial information that would be affected by the amended regulation includes information "in pending and approved applications for...market regulated articles such as new drugs, new animal drugs, medical devices, biological products and food additives," as well as information contained "in agency-prepared reviews of such applications," the notice states. By establishing "that foreign government officials are not members of the public," the proposed amendment would permit FDA to disclose confidential information to a foreign government, upon receipt of a written guarantee to protect the material. Such disclosure would function "as part of cooperative law enforcement or regulatory efforts, including efforts to facilitate evaluation" of approvable and nonapprovable products and "to expedite the withdrawal of products no longer shown to be safe and effective." The proposal distinguishes "confidential commercial information" from "trade secrets," which would remain restricted. The definition of trade secrets includes proprietary information related to sales statistics, customer and supplier lists and profit and loss data, as well as information involving manufacturing methods and processes. Trade secrets would not be disclosed "without the express written consent of its submitter in the form of a waiver," the notice states. The notice cites ddI (Bristol-Myers Squibb's Videx) as an example in which current restrictions hindered the sharing of important information between FDA and its Canadian counterparts and potentially could have held up the approval of the drug. The two countries ultimately circumvented the disclosure restrictions via special, one-time agreements. Videx was approved simultaneously by the two nations in October ("The Pink Sheet" Oct. 14, 1991, p. 15).
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