A bill to amend the Federal Food, Drug, and Cosmetic Act to strengthen the authority of the Food and Drug Administration to control the use of drugs which present risks to the public and to secure data on adverse reactions to drugs, and for other purposes.

Summary

Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services to impose restrictions on the distribution, dispensing, and administration of prescription drugs determined to present significant risks to patients or public health without such restrictions. Authorizes the imposition of such restrictions as a condition of approval for, or continued use of, new drugs. Prohibits the imposition of such restrictions on certain practitioners. Requires, for any drug determined to involve a risk of serious illness or injury, the voluntary and informed consent of the patient before the drug is dispensed. Requires a biennial evaluation of drug restrictions to determine whether they require modification or removal. Directs the Secretary, if necessary, to require persons approved to dispense new drugs to establish a system for identifying and collecting data on their effect on users and other clinical experience and to report to the Secretary on such data. Requires manufacturers of non-prescription drugs to establish a similar system and to make similar reports to the Secretary. Directs the Secretary to establish in the Food and Drug Administration a National Center for Drug Surveillance to coordinate such data collection. Requires the Secretary to report to Congress not later than six months after the end of a fiscal year on the information and data collected under this Act. Directs the Secretary to establish a program to encourage physicians, institutional health care providers, and patients to report adverse reactions to drugs to the National Center for Drug Surveillance.

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1 official file

• Introduced in House

  summary · EN · 21 July 1983

  Open at official source

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