A bill to allow patients access to drugs and medical devices recommended and provided by health care practitioners that are not approved by the Food and Drug Administration, and for other purposes.
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.
Introduced in Senate
Sponsor introductory remarks on measure. (CR S14806-14807)
Read twice and referred to the Committee on HELP.
checking server…
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line