Volume 6

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 Congress, as amended : review of cooperation on drug policies among food and drug administration, national institutes of health, veterans' administration, and other agencies.

  • United States. Congress. Senate. Committee on Government Operations. Subcommittee on Reorganization and International Organizations
Date:
1964
Catalogue details

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 Congress, as amended : review of cooperation on drug policies among food and drug administration, national institutes of health, veterans' administration, and other agencies. Source: Wellcome Collection.

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    available individual new drugs whether or not their usefulness in medicine is established, including proposed new indications or routes of administration for old drugs. It also provides for a wider sampling of the opinions of outside consultants to aid the AMA’s Council on Drugs in its evaluation of available evidence. CONSULTANTS AVAILABLE TO AMA ON DRUGS The American Medical Association is in the unique position of be- ing able to call upon its membership to discuss any problem in medi- cine where a meeting of the best medical minds is required. Its Council on Drugs takes advantage of this position for its drug evalua- tion procedure by obtaining the opinions of experts on the available evidence on new drugs. For this purpose, the council maintains a file of over 1,000 consultants, representing the various medical specialities, who may be called upon to advise the Council on Drugs and supply expert opinion regarding new drugs and drug therapy (exhibit A). EFFORTS TO IMPROVE DRUG INFORMATION PROGRAMS Since the new program of drug evaluation has been in operation, a number of actions have been taken to improve the presentation of in- formation on evaluated drugs: 1. The listing of trade names as a matter of information to aid physicians and others who may be unfamiliar with nonproprietary terminology under which evaluated drugs are described. 2. Expanded table of contents of 1958 edition of New and Nonofiicial Drugs to include page reference to subsection, as well as chapter title, to make such information more accessible. The contents were reor- ganized and the chapters retitled so that the 1958 edition of NND pre- sented an improved classification of drugs described. 3. The listing, in the Journal of the American Medica] Association and in NND 1958, in conjunction with the publication of monographs and as an aid to prescribing, of appropriate generic terms and avail- able dosage forms of individual drugs. 4. The adoption of a revised format of monographs to include a summary of the Council on Drugs’ opinion, to provide the reader with a thumbnail sketch of the expert view, and to incorporate additional subheadings and other features designed to increase the attractiveness and readability of the monographs. Monograph statements present the views of the Council on Drugs on each new drug evaluated with respect to its actions, uses, side effects, precautions, dosage, preparations available and other pertinent char- acteristics such as chemistry, pharmacology, mechanism of action, and metabolism, if known. The evaluation (exhibit B) is based on the available scientific laboratory and clinical evidence, and may be either favorable or unfavorable. Excerpts from representative monographs are given in exhibit C. The introduction of new dosage forms, changes in dosage require- ments, new indications, serious new toxic manifestations, and to some degree further information on the less serious adverse reactions have served as a basis for revising existing monographs in NND. Progress is being made in the improvement of the content and format of NND