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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DRUG COMPANY PROBLEMS Some readers will find of particular interest the helpful observations by the director of research of a pharmaceutical company, pointing out the exceedingly difficult problems faced by drug companies under the new laws and regulations, particularly in the instance of smaller enterprises. This scientist noted, for example, with concern: “During the past year our Government branches have tended to place a premium on lack of positive action [on New Drug Applications]” (p. 1247). UNDERESTIMATE OF ADVERSE REACTIONS Many readers may find significant the extensive information as to adverse reactions. Some readers may, for example, wish to read in detail the statement by the Public Health Service on the considerable number of “therapeutic mis- adventures”: “We believe this [official—ed.] figure of 1,368,000 is probably an underestimate” (p. 1124). COMPLEX ISSUE AS TO ALLEGED MALPRACTICE Some readers may note the unsolicited observation by a physician on the (controversial) effects of widespread lawsuits on alleged medical malpractice: * “T believe Mr. Belli, of California, who has been called ‘the King of Torts’ has been a far greater influence on the conscience of drug manufacturers than Mr. Kefauver” (p. 1241). A PRINCIPAL PROBLEM—FEDERAL EXCELLENCE To a committee such as ours, the Senate Committee on Government Opera- tions, a major question is: ‘Do the exhibits in this volume indicate that, by and large, Federal scientific and regulatory programs in the Food and Drug Adminis- tration have been characterized by general excellence? Or, do these hearing exhibits indicate that the caliber has been lower than it should have been?” The answer to this question will be provided in the subcommittee’s final report. A fair and tentative conclusion would, I believe, be that the exhibits do indicate that ‘‘all has not been well” within the Food and Drug Administration and that to say the least, excellence has not uniformly prevailed. This assertion, in itself, is not conclusive; when it is proved (as I believe will be the case), one must understand the reasons for the lack of excellence; one must determine whether the reasons were or were not within the agency’s whole or partial control. For example, some of the exhibits reflect the chronic handicaps under which the agency has had to work, unfortunately. I have often stated that FDA has, regrettably, ‘been under-staffed, under-paid, under-equipped, under-appreciated, and under-supported.” The question is, however, ‘‘are these the only reasons for weaknesses?” The answer, I believe, is ‘“‘no.’’ One must look to deeper causes for the answer. In any event, whatever may be the reasons which may have contributed to weaknesses, the fact is that weaknesses have existed within the agency. A further question is: “How significant are the weaknesses?” An additional question is: “Are the instances of weaknesses which are cited relatively rare or are they frequent; i.e., are they the exception or are they the rule?” This memorandum does not, of course, attempt to answer these broad and crucial questions. The subcommittee’s final report will endeavor to do so. 1 As indicated in the exhibits, the subcommittee has received many messages from attorneys. The subcommittee has uniformly informed them as a matter of policy that (a) as regards input, the subcommittee is interested in receiving solely such information as might prove pertinent to its factfinding efforts on matters directly involving agencies of the U.S. Government; (b) as regards output—the facts which the subcommittee finds are made available to the Congress as part of its legislative duties and to the Nation as part of the Nation’s right to be informed on Federal issues. How these facts—once published—may ultimately be used is beyond our control or purview; (c) an exhibit in vol. 4 will contain a letter received by the subcommittee from the U.S. Department of Justice as regards the Federal issue of some lawsuits, filed against the U.S. Government because of alleged malpractice with drugs in Federal clinical programs.

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