A bill to amend the Public Health Service Act to provide for a National Center for Clinical Pharmacology, to provide support for the study of clinical pharmacology and clinical pharmacy, and to provide for review of drug prescribing; and to amend the Federal Food, Drug, and Cosmetic Act to provide for recordkeeping and reporting for all drugs, to provide for certification of programs respecting manufacturers' representatives, to provide for the submission of data relating to therapeutic equivalence of drugs, to provide for the certification of certain drugs, to provide for a national drug compendium, to provide additional drug information to consumers, to establish a code system for the identification of all drugs.
Drug Utilization Improvement Act - Title I: National Center for Clinical Pharmacology - Establishes within the Department of Health, Education, and Welfare an office to be known as the National Center for Clinical Pharmacology. Empowers the Secretary of Health, Education, and Welfare to make grants for (1) the teaching of clinical pharmacology to all health science students; (2) continuing education of health professionals in clinical pharmacology; and (3) the training of specialists in clinical pharmacology and clinical pharmacy. Sets forth general rules governing the making of such grants.
Directs the Secretary to collect, analyze, and disseminate data relating to drug experience, including information concerning the reported and estimated incidence of adverse drug reactions, the causes of such reactions and the severity of such reactions. Prescribes the procedures for annual dissemination of such data.
Provides that the Secretary shall conduct a comprehensive investigation to determine the extent of inappropriate prescribing of drugs and whether there exists a need to establish additional mechanisms to control such inappropriate prescribing. Directs that consideration be given to all appropriate mechanisms, including: (1) a national drug formulary, (2) an office through which drug information is made available at all times and without cost to practitioners licensed by law to prescribe and administer drugs, (3) a system or systems of review of drug prescribing and administering, and (4) a program of periodic detailing of drug information to practitioners through individuals who have no financial interest in the sale of any drug product.
Calls for additional programs directed toward: (1) a study of the feasibility and effect of developing a system of controls over prescription drugs to see if some drugs should be restricted to hospital use or specialist use; (2) the development of a drug safety assurance plan to reduce improper prescribing to be updated annually; and (3) the mandating of drug utilization review for all health care delivery funded under this Act.
Authorizes appropriations totaling $11,000,000 for fiscal year 1975 and $16,000,000 for fiscal year 1976 to carry out the purposes of this title.
Title II: Promotional Practices - Bans, under the Federal Food, Drug, and Cosmetic Act, gifts, products, premiums, prizes or other things of value to practitioners and pharmacists. Allows for educational material to be distributed to such persons. Bans samples, except upon written request of practitioners licensed to prescribe drugs. Requires the practitioner to identify the reason for samples. Requires practitioners and companies to keep records of each sample.
Places prohibitions on the conducting of prescription surveys. Requires the inclusion of price information in drug advertisements. Bans reminder advertisements with exceptions for catalogs, and price lists. States that if an article is alleged to be misbranded because the labeling or advertising relating to such article is misleading there shall be taken into account not only the representations made or suggested, but also the extent to which the labeling or advertising fails to reveal material facts.
Requires the certification of training programs for manufacturers' representatives. Requires a card to be delivered to physicians on each encounter which summarizes indications, contraindications, side effects, warnings and cautions.
Title III: Drug Quality - Directs the Secretary to establish requirements for proof of therapeutic equivalence to assure reasonably uniform therapeutic performance among chemically equivalent drug formulations for each drug or class of drugs subject to this Act. Gives the Secretary authority to require batch testing of any drug when necessary to protect the public health and safety. Expands the Secretary's authority to require recordkeeping and reporting for drugs.
Title IV: National Drug Compendium - Directs the Secretary to publish and distribute a drug compendium, listing, by established name, specified drugs which are lawfully available in the United States, arranged by therapeutic classification and by such other classifications (diagnostic, prophylactic, or otherwise) as the Secretary may deem appropriate.
Outlines the procedures for hearings by any person who is adversely affected by the Secretary's inclusion or failure to include information in the compendium.
Establishes, for the purpose of advising the Secretary on matters pertaining to the compendium, an advisory committee consisting of persons, qualified in the pharmacology, safety, efficacy, and relative therapeutic value of drugs, appointed by the Secretary without regard to the civil service and classification laws, at least three of whom shall be practitioners licensed by law to prescribe and administer drugs.
Gives the Secretary specified powers to collect information necessary for publication of the compendium.
Title V: Consumer Drug Information - Requires that established (generic) names be on all labels. Establishes a uniform code or system of coding to identify manufacturer, identity of the drug, identity of final packager, dosage form and strength and number of units in the container. Requires pharmacies to post prescription drug prices as determined in regulations by the Secretary.
Introduced in Senate
Referred to Senate Committee on Labor and Public Welfare.
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