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.
Obstetric Care Information Act - 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, upon her request, to inspect, copy, and have explained any medical records relating to her condition or treatment; (2) is informed, beforehand, of the side effects, risks, contraindications, and effectiveness of the procedures, drugs or devices, and of alternative methods of treatment; and (3) consents to 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 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.
Authorizes appropriations for such study.
Introduced in House
Introduced in House
Referred to House Committee on Energy and Commerce.
Referred to House Committee on Ways and Means.
For Further Action See H.R.139.
Referred to Subcommittee on Health.
Referred to Subcommittee on Health and the Environment.
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