I 
108TH CONGRESS 
2D SESSION 
H. R. 5429
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. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 6, 2004
Mr. SOUDER (for himself, Mr. KINGSTON, Mr. SESSIONS, Mr. SMITH of New 
Jersey, and Mr. BONILLA) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce 
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 Representa-
tives 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 MARI-
JUANA FOR MEDICINAL PURPOSES; META-
ANALYSIS BY NATIONAL INSTITUTE ON DRUG 
ABUSE. 
(a) IN GENERAL.—The Director of the National In-
stitutes of Health, acting through the Director of the Na-
tional 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 safe-
ty and health risks of smoking marijuana and the clini-
cally-proven effectiveness of smoking marijuana for medic-
inal 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 Direc-
tor shall transmit a copy of the report to the Commis-
sioner 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 re-
port on the Internet site of the Food and Drug Adminis-
tration. 
(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 Commis-
sioner 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 ad-
vocate 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 Com-
monwealth of the Northern Mariana Islands, American 
Samoa, Guam, the Virgin Islands, and any other territory 
or possession of the United States.
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