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
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Licence: Public Domain Mark

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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    You, personally, had graciously stated that our committee’s ‘diligence’ is “im- pressive.” Dr. Clement Smith (who had, incidentally, testified before our sub- committee in 1959) expressed ‘“‘satisfaction” over my “continued interest and ac- tivities in complicated matters of research and health.” And other physicians, likewise, have been complimentary. Third, let me state that the unanimity with which your colleagues concurred in your judgment on vitamin Ks; is most impressive. Their strong measure of agreement speaks eloquently for the skill,.experience and understanding which you personally brought to this problem. This was, of course, to be expected from an expert who enjoys such well-deserved eminence in the eyes of those best qualified to judge your many contributions to science. Fourth, no layman would presume in any way to dispute your analysis of each of the principal articles in the medical literature, as regards menadione in prenatal supplements, or, for that matter, on any other technical issue. Fifth, we turn to the basic issue, as I see it. It is a legal-administrative issue, unique to the Federal Government. It is the issue of fulfillment of the law. AS you appreciate, this. particular issue is not a matter of how individual M.D.’s should practice medicine with their patients. That is and must remain the prerogative of medical science, alone. Physicians who have prescribed (and continue to prescribe) vitamin K; in prenatal supplements have exercised and continue to exercise their professional judgment. Each carefully evaluates evi- dence of potential benefits; each weighs possible hazard and then comes to his own decision in a manner which he feels will best serve his patient. No one here questions a physician’s and researcher’s prerogatives. But, the Congress and the Food and Drug Administration are required to deal with a separate and different issue—namely, the law—its prompt and effective fulfilment. Specifically, the Food Additive Law of 1958 does not (as I had pointed out) require that FDA prove harm by an ingredient like menadione; the law requires “reasonable certainty” on the part of the manufacturer as to safety. Dr. Nestor never contended that there was “proof” of harm; and I certainly never did. Indeed, I stated—very carefully—exactly to the contrary. As you recall, I stated in the Senate on April 2, 1968: I do not attempt to judge whether this or any other drug is safe or un- safe. I have merely described the doubts in the minds of medical and phar- macological officers. The fact that proof of safety does not exist does not, of course, mean that proof of harm exists. And, from a medical standpoint, Dr. Clement Smith, in his letter of April 25, 1963, very soundly stated: Careful observation and skepticism (both as to proof of harm and proof of harmlessness) must still be the physician’s guide. As for a guide to the Congress, let us look at a brief chronology. It consists, for purposes of simplicity, of but four key dates (out of scores of dates which might be cited, including those involving consultation with your own expert committee) : On September 6, 1958, President Hisenhower signed Public Law 85-929, the Food Additives Law. The law required, as the Senate and House Committee re- ports stated: ‘reasonable certainty that no harm will result” from a proposed use of a food additive. On March 12, 1962, after the issue was brought to his attention by other FDA physicians, John Nestor, a physician with a quarter-century of experience, wrote to William Kessenich, M.D., Director, Bureau of Medicine, Food and Drug Administration, that: Review of all the data available to me on this subject and consultation with several medical authorities both in the Bureau of Medicine of FDA and outside civilians confirms my previous opinion that neither the safety or efficacy of up to 1 milligram daily of menadione for use in a prenatal supplement has been proved. Dr. Evans, Dr. McGrath, Dr. Raffel, and Dr. Kelsey of the Bureau of Medicine of FDA concur with my opinion as do [various authorities whom he had consulted]. On May 24, 1962, Dr. Kessenich wrote to the Office of the Commissioner, FDA, that the Bureau questioned the safety of menadione to the fetus. Dr. Kes- senich stated: We cannot sustain the burden of proof of injury, but, there is, we feel, sufficient basis to raise the point that safety is not established. On March 28, 1963, 4144 vears after the law was enacted, 12 months after Dr. Nestor made his suggestion, and 10 months after his superior concurred in