ERIC Number: ED214658
Record Type: RIE
Publication Date: 1981-Jul-30
Reference Count: 0
Effects of Prescription Drugs During Pregnancy. Hearing Before the Subcommittee on Investigations and Oversight of the Committee on Science and Technology, U.S. House of Representatives, Ninety-Seventh Congress, First Session (July, 30, 1981).
Congress of the U.S., Washington, DC. House Committee on Science and Technology.
This hearing focuses on scientific and policy deficiencies in the area of drug-induced birth defects. Witnesses charge that (1) the Food and Drug Administration (FDA) does not require the kinds of clinical studies that are necessary to actually determine the safety of drugs used in pregnancy, (2) the FDA does nothing to enable women to find out about the effects of drugs during pregnancy even when such information could easily be made available, (3) the FDA does not do the kind of followup epidemiological studies that are necessary to clearly determine the safety of drugs in pregnancy, (4) the FDA's system for retrieving drug information on adverse effects is poor and this in turn obviously influences the quality of epidemiology, (5) labeling for physicians is not current, is often evasive, and is not based upon the best information available, (6) the majority of drugs given to pregnant women are not really approved by the FDA as safe for this use, and (7) most people, and particularly pregnant women, are not aware that the drug approval process is a "risk/benefit" process that limits the use of drugs that are not "safe" in the dictionary sense of the word. In addition to testimony related to these charges, teratological animal testing, epidemiological studies, bioethical issues, and the issue of informed consent are discussed. Numerous related documents are included in the record (RH)
Publication Type: Legal/Legislative/Regulatory Materials
Education Level: N/A
Authoring Institution: Congress of the U.S., Washington, DC. House Committee on Science and Technology.
Identifiers: Epidemiology; Food and Drug Administration; Informed Consent; Patients Rights; Public Safety; Teratology
Note: Some pages may be marginally legible due to small print size.