Volume 3

Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963.

United States. Congress. Senate. Committee on Government Operations

Date:: 1963

Credit: Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963. Source: Wellcome Collection.

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[H. Rept. 2464, 87th Cong., 2d sess.] Druc AMENDMENTS OF 1962 SEPTEMBER 22, 1962.—-Committed to the Committee of the Whole House on the State of the Union and ordered to be printed Mr. Harris, from the Committee on Interstate and Foreign Commerce, submitted the following report [To accompany H.R. 11581] % * * a * * % (p. 15) CONFIDENTIALITY OF INFORMATION OBTAINED BY INSPECTION, AND SO FORTH Section 202 of the bill amends section 301(j) of the basic act, which presently makes it a criminal offense for any person to use to his own advantage, or to disclose, other than to the Secretary or officers or employees of the Department, or to the courts, information acquired under section 404 (emergency permit control), 409 (food additives), 505 (new drugs), 507 (antibiotics), 704 (factory inspection), or 706 (color additives) of the basic act, where such information concerns any method or process which as a trade secret is entitled to protection. In view of the broadened factory inspection authority contained in the bill, the committee amendments to section 301(j) extend the prohibitions of this section to all information acquired under those sections, whether or not the information involves trade secrets. The committee also added to section 301(j) a proviso stating that nothing in the basic act shall authorize the withholding of information from the duly authorized committees of the Congress. This amendment will remove any basis for a claim by the Department of Health, Education, and Welfare that the Department is prohibited by the basic act from providing congressional committees information which they request. (Newspaper Article) September 29, 1962 Morton Mintz, in the Washington Post and Times-Herald: KENNEDY ASKS FUNDS FOR DruG CONTROL BILL (By Morton Mintz, Staff Reporter) President Kennedy asked Congress yesterday to give the Food and Drug _Administration a $2 million supplemental appropriation to implement new drug safety legislation.’ He also asked for $600,000 to enable FDA to carry out regulations proposed nese existing law to insure greater safety in the use of experimental drugs on umans. The House and Senate have passed basically similar drug bills that are ex- pected to be reconciled in conference Monday, with the resulting compromise apparently assured of enactment. In a related development, the Department of Health, Education, and Welfare Said it “would have no objection” to deleting from the House bill an administra- tion-sponsored revision that could extend certain bans on public disclosure of information to include dangers found in new drugs and additives. No comparable language is in the Senate bill, which includes factory-inspection provisions approved by the administration. 1 The first three paragraphs are reprinted for purpose of providing the context; the ppnining ois provide additional historical information for the present exhibit. (Editor’s note.

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