HR 5429
"The Safe and Effective Drug Act"



On Dec. 6, 2004, U.S. Rep. Mark Souder (R-IN) introduced HR 5429, "The Safe and Effective Drug Act," in the U.S. House of Representatives. Co-sponsors at introduction were Reps. Henry Bonilla (R-TX), Jack Kingston (R-GA), Pete Sessions (R-TX) and Christopher H. Smith (R-NJ).

Bill Number: HR 5429

Bill Title: To require the National Institute on Drug Abuse [NIDA] to develop a meta-analysis of the available scientific data regarding the safety and health risks of smoking marijuana and the clinically-proven effectiveness of smoking marijuana for medicinal purposes, and to require the Food and Drug Administration [FDA] to promptly disseminate the meta-analysis.

Status: Dec. 6, 2004 Referred to the House Committee on Energy and Commerce.

Bill Text:

A BILL

To require the National Institute on Drug Abuse to develop a meta-analysis of the available scientific data regarding the safety and health risks of smoking marijuana and the clinically-proven effectiveness of smoking marijuana for medicinal purposes, and to require the Food and Drug Administration to promptly disseminate the meta-analysis.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the `Safe and Effective Drug Act'.

SEC. 2. SAFETY AND EFFECTIVENESS OF SMOKING MARIJUANA FOR MEDICINAL PURPOSES; META-ANALYSIS BY NATIONAL INSTITUTE ON DRUG ABUSE.

(a) In General- The Director of the National Institutes of Health, acting through the Director of the National Institute on Drug Abuse (referred to in this Act as the `Director of the Institute'), shall develop a meta-analysis of the available scientific data regarding the safety and health risks of smoking marijuana and the clinically-proven effectiveness of smoking marijuana for medicinal purposes.

(b) Completion of Meta-Analysis; Report- Not later than 120 days after the date of the enactment of this Act, the Director of the Institute shall complete the meta-analysis under subsection (a) and submit to the Congress a report providing the meta-analysis. The Director shall transmit a copy of the report to the Commissioner of Food and Drugs.

 

SEC. 3. DISSEMINATION OF META-ANALYSIS BY FOOD AND DRUG ADMINISTRATION.
(a) Public Access to Meta-Analysis Through Internet- Not later than 30 days after receiving from the Director of the Institute the report under section 2(b), the Commissioner of Food and Drugs shall post such report on the Internet site of the Food and Drug Administration.

(b) Dissemination of Meta-Analysis to Certain Public Health Agencies and Other Appropriate Entities- Promptly after receiving from the Director of the Institute the report under section 2(b), the Commissioner of Food and Drugs shall disseminate the report--

(1) to principal public health agencies of all States, including those that authorize the smoking of marijuana for medicinal purposes; and

(2) to public health associations, health care professionals, and other appropriate entities that advocate or recommend the smoking of marijuana by patients for medicinal purposes.

(c) Definition- As used in this section, the term `State' means each of the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the Virgin Islands, and any other territory or possession of the United States.