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 woman with respect to her pregnancy or parturition: (1) has the opportunity, upon her request, to inspect, copy, and have explained any medical records relating to her condition or treatment; and (2) is informed, prior the performance of a procedure or the administration of a drug or device, of the side effects, risks, contraindications, and effectiveness of the procedure or the administration of the drug or device, of not performing the procedure or administering the drug or device, of alternative methods of treatment, and after being so informed the health care practitioner receives her consent to a 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 the use of women during pregnancy or parturition. Deems misbranded any drug or device offered for sale to a woman for use during pregnancy or parturition 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 the use of obstetrical drugs, devices, and procedures with respect to maternal health and child development and to report to Congress concerning such study.

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• Introduced in House

  summary · EN · 30 January 1980

  Open at official source

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