A bill to amend title V of the Social Security Act to require States to provide women access to their obstetric medical records and current information on obstetrical procedures, to amend the Federal Food, Drug, and Cosmetic Act to require the dissemination of information on the effects and risks of drugs and devices on the health of pregnant and parturient women and of prospective and developing children, and to provide for a study on the delayed long-term effect on child development of obstetrical drugs and procedures administered to or used by pregnant and parturient women.

Summary

Amends title V (Maternal and Child Health) of the Social Security Act to require a State plan under such title to insure that a pregnant woman: (1) has the opportunity to inspect, copy, and have explained any medical records relating to her condition or treatment; (2) is informed beforehand of the risks, contraindications, and effectiveness of procedures, drugs or devices, or of alternative methods of treatment; and (3) consents to such treatment. Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish guidelines with respect to the explanation of the side effects, risks, contraindications, and effectiveness of drugs and devices intended for use by pregnant women. Deems misbranded any drug or device offered for sale to a pregnant woman which does not meet such guidelines. Directs the Secretary to arrange for a study to determine the long-term side effects, risks, contraindications, and effectiveness of obstetrical drugs, devices, and procedures with respect to maternal health and child development and to report to Congress concerning such study. Authorizes appropriations for such study.

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• Introduced in House

  summary · EN · 5 January 1981

  Open at official source

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