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 a prescription drug if such drug poses significant risks to health without such restrictions. Directs the Secretary to require the informed consent of a patient before such patient uses such a drug if it would involve a risk of serious illness or injury. Requires the Secretary to review restrictions every two years to determine if they are still necessary. Authorizes the Secretary to continue to require information from an applicant for a new drug, including its effects on individuals and other clinical experience. Requires the manufacturers of nonprescription drugs to collect, maintain, and report to the Secretary on information on the effects on individuals and other clinical experience with such drugs. Directs the Secretary to establish in the Food and Drug Administration a National Center for Drug Surveillance to maintain the information submitted to it by the drug manufacturers. Grants the Secretary enforcement power concerning the collection and maintenance of such information. Requires the Secretary to report annually to the Congress the information acquired concerning adverse reactions to drugs and the actions taken by the Secretary. Directs the Secretary, through the Commissioner of the Food and Drug Administration, to establish and implement a program to encourage physicians, institutional health care providers, and patients to report adverse drug reactions to the Center.

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1 official file

• Introduced in House

  summary · EN · 21 March 1985

  Open at official source

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