Summary: S.1955 — 106th Congress (1999-2000)All Information (Except Text)

There is one summary for S.1955. Bill summaries are authored by CRS.

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Introduced in Senate (11/18/1999)

Access to Medical Treatment Act - Authorizes a patient to receive, and a health care practitioner (practitioner) to provide or administer, any unapproved drug or medical device (UDMD) that the patient desires or the patient's legal representative authorizes if: (1) the UDMD is recommended by a practitioner within his or her scope of practice; (2) the provision or administration of the UDMD is not a violation of applicable State law; and (3) the practitioner abides by the requirements of this Act. Includes among such requirements that the practitioner: (1) does not violate the Controlled Substances Act; (2) has concluded that the UDMD will not cause a danger to the patient; (3) gives the patient sufficient opportunity to decide whether or not to receive such UDMD; (4) discloses any financial interest the practitioner may have in the UDMD; and (5) has informed the patient that the UDMD is not approved, of its risks and benefits, of alternative procedures, as well as certain related information designed to achieve informed patient consent of its use.

Requires UDMD manufacturers to disclose to practitioners receiving the UDMD all appropriate information to enable the practitioner to comply with such requirements.

Provides an exception for a practitioner's dissemination of information concerning the results of administration of a UDMD.

Requires a practitioner who discovers that a UDMD causes a danger to a patient to immediately cease its use and recommendation, and to provide to its manufacturer and the Director of the Centers for Disease Control and Prevention (CDC) a report containing all relevant information concerning such discovery. Requires a manufacturer receiving such a report to immediately cease sale and distribution of such UDMD, notify all appropriate practitioners, and report such results to the Secretary of Health and Human Services.

Requires the CDC Director to: (1) upon receipt of a manufacturer's report, conduct an investigation of the UDMD to determine the actual cause of the danger; and (2) report such determination to the Secretary. Requires the Secretary, after such report, to: (1) direct a manufacturer to cease manufacture, sale, and distribution of a UDMD when it is determined to be the cause of the danger, and notify appropriate practitioners of such determination; (2) direct the manufacturer to inform appropriate practitioners when the UDMD is determined not to be the cause of the danger; and (3) direct the manufacturer to inform appropriate practitioners when the cause of the danger cannot be determined.

Requires the Secretary to promptly disseminate information concerning the danger of a UDMD to all U.S. health care practitioners, the Director of the National Center for Complementary and Alternative Medicine (National Center Director), and State agencies responsible for regulating unsafe or adulterated drugs and medical devices.

Requires a practitioner to report to the manufacturer of a UDMD that produces beneficial results. Requires such manufacturer to relay such report to the National Center Director. Requires the National Center Director to review and analyze such information and make available on the Internet and to the public a review and analysis of such information, including a statement that such drug or medical device is not approved by the Food and Drug Administration.

Authorizes practitioners to introduce UDMDs into commerce to the extent necessary to comply with requirements of this Act.

Denies coverage under this Act for practitioners and manufacturers found to have violated its requirements.