Summary: H.R.12980 — 95th Congress (1977-1978)All Information (Except Text)

There is one summary for H.R.12980. Bill summaries are authored by CRS.

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Introduced in House (06/05/1978)

Drug Regulation Reform Act - Title I: Drug Regulation Reform - States the findings of Congress.

Prohibits the manufacture, importation, export, or distribution of a drug entity or a drug product without the prior issuance by the Department of Health, Education, and Welfare of a monograph containing a description of such drug and requirements and guidelines for the contents of information labeling for the forms of drug products eligible for licensing under such monograph.

Authorizes the Secretary of Health, Education, and Welfare to require, in a monograph, postmarketing surveillance of any drug, old or new, for a period of up to five years. Limits the issuance of such monographs to drugs determined safe and effective. Defines "safe" as meaning the health benefits of the drug entity or product clearly outweigh the risks it presents, taking into account pertinent standards and requirements. Defines "effective" to mean that a drug entity when incorporated into a drug product used in accordance with the use conditions set forth on the drug label, will have the effect represented. Provides for amendment, suspension, or revocation of a monograph under specified conditions.

Authorizes the provisional issuance of a monograph (not to exceed five years) for any drug entity intended to be used in treatment of a life-threatening or severely debilitating disease when: (1) no other effective methods of treatment exist; or (2) such drug entity offers a major advantage to patients compared to the benefits of alternative methods; and (3) delaying issuance would present significantly greater risks to patients affected by such disease. Requires significant evidence of effectiveness and safety for such provisional issuance.

Establishes a monograph-petition review procedure requiring a public hearing on the issuance, amendment, or revocation of any monograph, followed by a review of the evidence and issues by a drug science advisory committee, whose recommendations shall be forwarded to the Secretary for his final decision. Authorizes judicial review of a final order of the Secretary by a United States Court of Appeals.

Requires, with specified exceptions, the registration of domestic and foreign establishments engaged in the manufacture, importation, export, or distribution of any drug entity or drug product.

Prohibits for five years after the issuance date of a monograph the licensure of any drug product without: (1) written authorization from the monograph petitioner; or (2) data and information independent of the monograph which would support a determination that the monograph could be issued. Permits the licensure of a drug product, after the expiration of such five year period, without the making of necessary animal and clinical studies already made to demonstrate the safety and efficacy of the drug product under the original monograph.

Requires registration of any drug to be used in a drug investigation, and revocation of registration if the human participants in the investigation are subject to unreasonable and significant risk of illness or injury. Specifies standards and requirements for such investigations. Requires the informed consent of participants in such investigations unless the immediate use of the drug product is, in the investigator's opinion, needed to preserve the participant's life and time is not sufficient to obtain either consent from either the participant or his legal representative.

Authorizes the Secretary to: (1) issue written guidelines regarding protocols and methods for conducting investigations; and (2) to review and advise, upon request, regarding specified aspects of a drug investigation.

Requires unlicensed drug products and drug entities not subject to monographs to obtain permits for export to foreign countries. Specifies requirements for such exports.

Exempts homeopathic drug entities and products from monograph, licensure, and investigational use requirements if manufactured or imported in accordance with import/export registration requirements of this Act.

Requires: (1) patient information labeling in layperson's language of the risks, benefits, side effects and so forth of any drug entity or product; and (2) practitioner information labeling that identifies the licensee, registrant, permittee and manufacturer of such drug.

Directs the Secretary to prepare and publish a compendium of all prescription drugs eligible for licensing under issued monographs.

Prohibits from the promotional labeling of any prescription drug product indications for use, comparisons with other drug products, or dosage recommendations not contained in the information labeling of such product.

Prohibits drug product licensees and their agents from: (1) distributing sample prescription drug products without charge; and (2) providing services or transferring items to specified medical personnel or their families, if the value of the service or item is at least $5.00, and no charge is made. Requires disclosure of the sponsorship by a drug product licensee or distributor of medical and scientific educational materials (other than labeling).

Forbids the disclosure by pharmacists and their agents of prescriptions or information contained in prescriptions to anybody but the patient, the prescribing practitioner, or other specified persons. Prohibits licensees and their agents from obtaining or attempting to obtain such information.

Prescribes civil, criminal, and administrative penalties, and subjects drug entities and products to seizure, for violations of this Act.

Authorizes the Secretary to compel the attendance and testimony of witnesses in any matter relating to implementation or enforcement of this Title.

Authorizes the Secretary to inspect drug manufacturing and distributing establishments to determine compliance with this Title.

Limits the application of the provisions of this Title to drugs intended for human use.

Title II: National Center for Clinical Pharmacology; Evaluation of the Act - Amends the Public Health Service Act to establish, in the Department of Health, Education, and Welfare, the National Center for Clinical Pharmacology to conduct and support, by grants: (1) research in clinical pharmacology and clinical pharmacy; and (2) an ongoing review and analysis of the use of drug products in the United States.

Directs the Secretary to contract for an independent evaluation of Title I and its effect on: (1) protection of the public against adverse reactions from and misuse of drug products; (2) innovation in drug research; (3) the economics of the pharmaceutical industry; (4) the cost of drug products; (5) prescribing practices; and (6) the time required for the issuance of monographs. Requires a report on such evaluation to the appropriate Committees of Congress within seven years of enactment.