FDA's ABILITY TO PROTECT TRADE SECRETS FROM CONGRESS IS CONSTRAINED

FDA's ABILITY TO PROTECT TRADE SECRETS FROM CONGRESS IS CONSTRAINED under a little-noticed "miscellaneous" provision of the recently enacted fiscal year 1990 budget reconciliation legislation. The provision is contained in a paragraph of Section 4755 of the measure. Effective retroactively to Jan. 1, 1990, the provision amends Sec. 301(j) of the FD&C Act by stipulating that the section "does not authorize the withholding of information from either house of Congress or from . . . any committee or subcommittee of such committee or any joint committee of Congress or any subcommittee of such joint committee." In recent years, FDA has opposed Congress over disclosure of potentially sensitive information from industry market applications. FDA's former Chief Counsel Thomas Scarlett had a public dispute with staff of Rep. Dingell's (D-Mich.) House Oversight Subcommittee over the disclosure issue when congressional aides tried to remove ANDA records from what was then called the Generic Drug Division early in the generic drug industry investigation. In addition, Rep. Weiss (D-N.Y.) protested to then-Commissioner Young when FDA edited documents containing companies' scientific data related to NDAs before supplying them to the congressman's House Intergovernmental Relations Subcommittee. Sec. 301(j) of the FD&C Act currently prohibits the disclosure of trade secret information to anyone but HHS or the courts. Specifically, it bars the use "by any person to his own advantage, or revealing other than to the secretary or officers or employees of the department, or to the courts when relevant to any judicial proceeding under this act, any information acquired under authority of section . . . concerning any method or process which as a trade secret is entitled to protection."