FDA ACCESS TO COURT-PROTECTED DOCUMENTS WOULD BE AUTHORIZED

Executive Summary

FDA ACCESS TO COURT-PROTECTED DOCUMENTS WOULD BE AUTHORIZED under a bill to be introduced by Rep. Weiss (D-N.Y.) later this year. In an April 16 statement, Weiss said that "when Congress reconvenes, I will introduce legislation that would give FDA the authority to obtain information that is otherwise sealed, and to make it public when necessary for public health." FDA's inability to penetrate court protective orders was highlighted in late 1991 by the agency's investigation of silicone gel-filled breast implants. Safety information on silicone gel-filled breast implants manufactured by Dow Corning that had not been submitted to the agency was publicized in media coverage of product liability trials. Even after learning of the information, FDA had difficulty in attaining the documents due to court protective orders. The issue eventually became moot when Dow Corning released 800 pages of internal business memos and scientific safety studies to the public in February. Weiss requested that the Justice Department conduct a criminal investigation of Dow Corning related to the firm's failure to disclose the safety information. The congressman was recently informed that Justice has begun investigating the case. While Weiss' interest was prompted by the breast implant controversy, the bill has relevance in the pharmaceutical arena as well. The "transcription errors" found in Upjohn's Halcion application, for example, were originally discovered as part of a civil case in which the documents were sealed. Upjohn subsequently reported the data to FDA. The company ultimately relabeled the product.