H.R.2635 - Access to Medical Treatment Act106th Congress (1999-2000)
|Sponsor:||Rep. DeFazio, Peter A. [D-OR-4] (Introduced 07/29/1999)|
|Committees:||House - Commerce|
|Latest Action:||08/27/1999 Referred to the Subcommittee on Health and Environment. (All Actions)|
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Summary: H.R.2635 — 106th Congress (1999-2000)All Bill Information (Except Text)
Access to Medical Treatment Act - Defines: (1) "danger" as an adverse reaction to an unapproved drug or medical device that causes serious harm, would not otherwise have occurred, and is more serious than contraindications for drugs or devices approved by the Federal Food and Drug Administration for the same disease or condition; and (2) other terms as used in this Act including, "unapproved drug or medical device."
Introduced in House (07/29/1999)
(Sec. 4) Allows, notwithstanding any other provision of Federal law, a patient to receive and a health care practitioner to provide any unapproved drug or device the patient desires if it is: (1) recommended by a practitioner (within that practitioner's scope of practice); (2) not a violation of State law; and (3) the practitioner abides with all recommendation requirements. Sets forth the recommendation requirements, including that the practitioner: (1) does not violate the Controlled Substances Act; (2) has informed the patient of certain matters, including that the drug or device is unapproved and experimental; and (3) does not impose a charge for the drug or device in excess of costs. Prohibits the practitioner from making any advertising claims for the drug or device, but allows dissemination of information on the results of the practitioner's use of the drug or device so long as: (1) the practitioner does not offer to sell the drug or device in connection with the dissemination; or (2) the claims are permitted under provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) relating to misbranded food and to dietary supplement labeling.
(Sec. 5) Requires a practitioner who discovers that an unapproved drug or device creates a danger to a patient to immediately cease use and recommendation of the unapproved drug or device and provide specified information to the drug's or device's manufacturer. Requires the manufacturer that receives the information to: (1) immediately cease sale and distribution of the drug or device; (2) notify all practitioners to whom the drug or device has been provided; (3) report to the Secretary of Health and Human Services. Directs the Secretary, on receiving the report from the manufacturer, to promptly disseminate information on the danger to all practitioners in the United States, the National Center for Complementary and Alternative Medicine, and agencies of States having responsibility for regulating unsafe or adulterated drugs and devices. Requires the manufacturer to investigate to determine the actual cause of the danger and take specified actions depending on the outcome of that investigation.
(Sec. 6) Requires a practitioner who discovers that an unapproved drug or device used in the treatment of a life threatening condition produces results that are significantly more beneficial than results from approved drugs or devices for that condition to provide specified information to the drug's or device's manufacturer. Requires that manufacturer to provide information to the National Center for Complementary and Alternative Medicine. Requires the Center to annually report to Congress on beneficial results and make the report available to the public.
(Sec. 7) Declares that this Act does not: (1) have any effect on FDCA provisions regarding pharmacy compounding; and (2) supersede any State or political subdivision law.
(Sec. 8) Authorizes a practitioner, in conformity with this Act, to take certain actions regarding an unapproved drug or device and interstate commerce.
(Sec. 9) Requires that a practitioner found to have knowingly violated this Act be denied coverage under this Act.