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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QUESTIONS AS TO TIMING Many of the exhibits raise questions as to timing of regulatory decisions.. As indicated earlier (p. 819), timing is crucial. A regulatory agency should be neither too fast (i.e., premature and rash), nor too slow. Evidence from profes- sional sources has been that FDA has, at times, been too slow in protecting the public health. (See p. 1252, for example, as to alleged delay on a regulation on over-the-counter antibiotics. ) ADDITIONAL EXAMPLE: DANGER IN IMPROPER STORAGE—4 YEARS BEFORE PRECAUTIONARY LETTER AND ACTION In 1959 (pp. 1245-1246) a physician wrote to a drug company and to the Food and Drug Administration with regard to the need for careful storage procedures so as to protect a potent useful drug, tetracycline, from decomposing into a dangerous product. In April 1968, after the issue was raised in the open litera- ture,’ the physician wrote to FDA expressing dissatisfaction with the way the agency had handled the case originally. Four years after the physician’s original comment to FDA, Lederle Labora- tories sent out (on August 23, 1963) a “Dear Doctor” Letter.’ It cautioned, in effect, as to effects of improper storage under “extreme conditions of heat and humidity” on tetracycline antibiotic capsules in developing “certain degrada- tion products.” Is 4 years the shortest period of time within which the need for such a warning could have been studied and the warning sent? ANOTHER EXAMPLE—VITAMIN K—10 MONTHS’ DELAY On May 24, 1962, the Bureau of Medicine of the Food and Drug Administration concluded (pp. 956, 959) that a drug, Vitamin Ks, should not be on the over-the- counter market in prenatal vitamin capsules because proof of safety did not exist. On March 22, 1963, there was finally published in the Federal Register (p. 958) the order denying further use of the drug in prenatal vitamin capsules on an over-the-counter basis. Was 10 months the shortest period of time that might reasonably have been expected under the circumstances? KONAKION—9 MONTHS’ DELAY FDA noted with pride (p. 1112) that on July 27, 1962, an alert physician tele- phoned it with regard to adverse reaction from Konakion. On October 18, 1962, the company submitted revised labeling, mentioning the fatal reaction which had been reported. ; Nine months later, in July 1963, the company sent out a “Dear Doctor” Warn- ing Letter (p. 1180) concerning the danger. Is this the shortest period of time within which such a warning letter could and should have been sent? No one would, of course, attempt to answer any of the above questions “off the cuff.” Each case must be studied in detail in order to arrive at a fair answer. MER-29—SERIOUS IMPLICATIONS FOR EVALUATION Many of the exhibits are inherently highly technical. That is particularly true of the MER/29 exhibits. Only a scientist can properly evaluate them. The evaluation is urgently necessary. For example, one scientist (outside FDA) who commented on exhibit 128, in particular, has stated this view to the sub- committee: During the drug’s active usage, the company’s brochure to practicing physicians allegedly failed to inform adequately of the potential implications of the desmosterol problem. He said: “The whole clinical chemistry method gave a falsely low [indication] for total sterol levels. The practicing physician should have [been informed |] pont he [could not] rely on ordinary laboratory help for evaluation of his herapy,”’ On another phase of MER/29, weaving throughout its entire history is the Significant thread of possible effect of the drug in producing cataracts. The reader will wish to examine each such reference carefully in the interest of 2 See article referred to by the doctor, as well as a subsequent letter to the editor of the Journal of the American Medical Association, by Frimpter, George W., M.D.; Timpanelli, Alphonse B., M.D.; Hisenmenger, William J., M.D.; Stein, Howard S., M.D.; Ehrlich, Leonard I., M.D., New York, Aug. 8, 1963, vol. 185, No. 5, p. 414. ®The principal element of the letter was announcement of an “important change” in the capsules to Lactose U.S.P. “for the better protection of your patients.” The letter stated that new laboratory studies confirmed that “in the presence of Lactose U.S.P.., tetracycline shows little or no degradation even under the most severe test conditions” (in contrast to the possibility, formerly, with citric acid).

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