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.

424/504 page 1190

Present law forbids any person from using “to his own advantage” or from disclosing to anyone other than HEW personnel or the courts, information that concerns “any method or process which as a trade secret is entitled to protection.” LIMITATION REMOVED At FDA’s urging, the trade-secret limitation was removed. In its report on the bill, the House Commerce Committee said the deletion extends the disclosure prohibitions to FDA information “whether or not (it) involves trade secrets.” Questioned by Representative John E. Moss, Democrat, of California, chair- man of the House Government Information Subcommittee, FDA Commissioner George P. Larrick said that: FDA requested the revision ‘‘to make it prefectly clear that * * * there would be adequate safeguards against” an employee’s use to his own advantage of in- formation gathered under the broadened factory-inspection powers the bill would grant. The revision would not diminish HEW’s authority to report on investigations involving imminent danger to health or gross deception of the consumer. FDA intends to continue to giving ‘‘a full reporting” of facts that ‘‘are in the public interest.” INFORMATION TO CONGRESS At the request of Representative L. H. Fountain, Democrat, of North Carolina, the Commerce Committee added language forbidding the withholding of informa- tion from Congress. In June, Fountain told the committee that FDA had withheld information from his Intergovernmental Relations Subcommittee on two drugs, MER/29 and Flexin, which “‘were withdrawn from the market due to the discovery of dan- gerous side effects.” Fountain testified that the subcommittee wanted to find out whether the FDA, which had previously cleared the drugs for sale, ‘had fully and effectively met its responsibilities.” Fountain said that Larrick refused to make the files on the drugs available, but promised to compile and deliver summaries “promptly.” The summaries did not become available until several weeks later. Fountain also testified that Larrick had “incorrectly” written him that FDA has “uniformly declined to make the files available to anyone except” FDA employees. He said his subcommittee’s staff ‘has examined such files in the past.” {H. Rept. 2526, 87th Cong., 2d sess.] Druc AMENDMENTS OF 1962 OcTOBER 3, 1962.—Ordered to be printed Mr. Roserts of Alabama, from the committee of conference, submitted the fol- lowing conference report [To accompany S. 1552] * * * * * * * CONFIDENTIALITY OF INFORMATION OBTAINED BY INSPECTION The House amendment amended section 301(j) of the Federal Food, Drug, and Cosmetie Act with regard to the confidentiality of information obtained by inspection. The Senate bill did not contain a similar provision. The conference substitute omits the provision contained in the House version amending section 301(j) of the act. This leaves existing law on this subject unchanged.

Licence and re-use

Contents

Volumes