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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    ings clearly demonstrated that the usefulness of this drug had never been established and this was a factor in the safe use of a drug intended for serious infections. Before the Kefauver committee, the Commis- sioner of FDA had voiced a similar interpretation that drugs for seri- ous conditions must be efficacious if they are to be safely used without depriving the patient of proper and necessary treatment to overcome his infection. Even though the Deputy Commissioner reviewed and upheld * the findings of the HEW Hearing Examiner * to suspend the New Drug Application for Altafur, there was never an internal appraisal to de- termine how this drug was allowed to clear the FDA new drug proce- dure or why the firm was allowed a 3-month period of grace for fur- ther marketing after the risks were known to the FDA. THE CASE OF MENADIONE 7° Another example of the problems confronting physicians within the FDA is illustrated by menadione (vitamin K;). This problem came up in connection with a Food Additive Petition for its inclusion in vita- min capsules for use in pregnancy. Menadione was already on the market in a variety of such preparations for both prescription and over-the-counter distribution. Under the food additives amendment, FDA must consider both safety and efficacy in evaluating a food addi- tive. Both the Division of Nutrition and the Division of Pharmacology were of the opinion that the animal and nutritional data would support the manufacturers who submitted the petition. Unfortunately, it was overlooked that a pregnant woman carries a fetus and that babies are sometimes born with jaundice (hyperbilirubinemia). Thus, in turn, can result in kernicterus, brain damage, spasticity, and death. My colleagues and I recommended that the petition be denied on the basis that there were insufficient data to substantiate the safety or efficacy for this use. Asis frequently the case in FDA, we were put in the diffi- cult position of being told of the cost to the pharmaceutical firm. The then Director of the Division of Nutrition, who is now the Assistant Commissioner for Science, did not want to reverse his favorable opin- ion to allow the petition and cited the expense to the firm of either withdrawing the drug from the market or supporting adequate studies to demonstrate safety and eflicacy. It then became necessary for us to enlist the aid of physicians out- side of FDA and I telephoned or wrote to several. The following quote is an illustration of their concern for safety and the doubt of the need or usefulness of menadione in pregnancy vitamin capsules. Dr. William A. Silverman, chairman of the Committee on Fetus and Newborn of the American Academy of Pediatrics, wrote on March 10, 1962: DEAR Dr. NEstToR: As you know, the Committee on Fetus and Newborn has been concerned with the matter of potentially harmful effects on the human fetus produced by drugs administered to the pregnant mother (Pediatrics 28: 278, 1961). In this connection, I was disturbed to hear that it has now been proposed that pregnant women receive daily supplements of menadione to prevent hemorrhagic disease in their offspring. 24 See exhibit 130, p. 947. 2 See exhibit 131, p. 948 7 Hor an FDA chronology of actions on the Food Additive Petition on Menadione, see exhibit 132, p. 955. For an additional chronology on the same subject, but prepared from diverse sources, see exhibit 133, p. 958.