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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MYSTERY OF THE BUTYLATED TwiNs—A FURTHER Reporr *° THE FOOD AND DRUG ADMINISTRATION SAYS ITS POLICY “HAS ALWAYS BEEN TO MAKE AVAILABLE TO PUBLIC SCRUTINY” INFORMATION OF A SORT WHICH IT DENIED EARLIER TO AN INQUIRER. BUT THE AGENCY’S ACTIONS AND ITS OWN RULES SAY OTHERWISE Events followed quickly upon our report, in Consumer Bulletin for October 1961, of difficulties in obtaining for study a paper entitled “Summary of Toxicity Studies on Butylated Hydroxyanisole.” Indignant readers, including several physicians, wrote about the matter to the Food and Drug Administration; to Health, Education, and Welfare Secre- tary Abraham Ribicoff; and to their Senators and Congressmen. An influential big city newspaper, the Philadelphia Bulletin, editorialized about the “new example of suppression by the Government of information in its files to which the public has a right of access.” On the same day as the newspaper’s editorial appeared, Deputy Commissioner John L. Harvey of the Food and Drug Administration sent off two letters. One went to the editor of Consumer Bulletin and said in part: “We agree with your premise that data on which we make decisions to per- mit use of chemicals in foods should be available to public scrutiny, and regret that there has been a misunderstanding of our policy on the matter. * * * “Since it has developed that the ‘Summary’ is not available elsewhere, we are giad to furnish you—and anyone interested—a photocopy of our file copy.” The other letter of which we have knowledge that Mr. Harvey wrote on that day was addressed to a Consumer Bulletin subscriber, who kindly sent us a copy. There was an interesting additional remark which we have italicized below : “On the general principle, however, we agree with you completely that the scientific information on which we base decisions on whether to permit certain chemicals in foods should be made available to public scrutiny. This has al- ways been our policy except where the law specifically protects confidential information provided to us by manufacturers.” Mr. Harvey became more explicit as time went on. In a letter to a Congress- man about 2 weeks later, he wrote (italics ours) : “The article submitted [Consumer Bulletin, October 1961] does not so state, but in the case of the American Meat Institute ‘summary’ as soon as we were advised that the inquirers were not able to get the material from the American Meat Institute, we made photocopies of our file reference and supplied these.” Consumers’ Research is pleased to know about the Food and Drug Administra- tion’s policy of freedom of information, but we cannot allow to pass without challenge the implications by Deputy Commissioner Harvey that this policy has always been followed by the agency. About 6 months before the dates of Mr. Harvey’s letters quoted above, a citizen wrote to the Food and Drug Administration, told the agency that the “Summary” could not be obtained from the American Meat Institute Foundation, and asked aid in obtaining or even borrowing a copy. (The inquirer was interested in the paper because the Food and Drug Administration previously had cited it to him as a source of needed information.) Following, in full, is the agency’s answer to the citizen’s request: DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, Foop AND DruG ADMINISTRATION, Washington, D.C., May 18, 1961. DEAR Mr. : This maaan to your letter of April 28 avout the Wilder paper on butylated hydroxyanisole. We are sorry that this paper is not available and apparently should not be listed among our references on this subject. You might inquire of the Meat Inspection Division of the Department of Agriculture, since your information indicates that the studies may have been made for that agency. We are not in a position to make our copy of the paper available. Sincerely yours, DorotrHy H. Korcrer, Consumer Inquiry Branch, Division of Public Information. 2e Consumer Bulletin, Aug. 1962, pp. 28-29. 88—311—-63—pt. 328

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