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CONFIDENTIAL INFORMATION RELEASE MAY REQUIRE WRITTEN AUTHORIZATION

Executive Summary

CONFIDENTIAL INFORMATION RELEASE MAY REQUIRE WRITTEN AUTHORIZATION from the product's sponsor & before FDA will provide such information to foreign government officials. Under a final rule issued in the Nov. 19 Federal Register, the agency is allowed to disclose nonpublic safety, effectiveness or quality information about FDA-regulated products to foreign government officials. In response to comments on the proposed rule, issued in June 1992 ("The Pink Sheet" June 29, 1992, T&G-8), the final rule more explicitly describes safeguards that apply to authorized disclosures of confidential information to foreign government officials. FDA emphasized that "the focus of this rulemaking is not on the nonpublic exchange of trade secret information." FDA received 22 comments on the proposed rule including 15 from manufacturers and three from manufacturers' associations. Responding to the comments, FDA said in the notice that "in addition to foreign governmental confidentiality assurances, any one of three additional conditions must be met: (a) written authorization by the submitter of the information; (b) a finding that disclosure is in the interest of public health by reason of the foreign government's possessing information concerning the safety, efficacy, or quality of the product or information concerning an investigation; or (c) the disclosure is to a foreign scientist visiting FDA as part of a joint review or long-term cooperative training effort that furthers FDA's regulatory mission." Addressing comments that the proposal is unnecessary, the agency pointed out that "the approval times in Europe and in the United States for the therapeutic biological products [Amgen's] Neupogen and [Chiron's] Proleukin varied significantly because of constraints on sharing data across national boundaries." The rule becomes effective Dec. 20, 1993 and written comments are due by March 21, 1994.
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