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 referred 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 metaanalysis.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Safe and Effective 

3 Drug Act’’. 

4 SEC. 2. SAFETY AND EFFECTIVENESS OF SMOKING MARI5 JUANA FOR MEDICINAL PURPOSES; META6 ANALYSIS BY NATIONAL INSTITUTE ON DRUG 

7 ABUSE. 

8 (a) IN GENERAL.—The Director of the National In9 stitutes of Health, acting through the Director of the Na10 tional Institute on Drug Abuse (referred to in this Act 

11 as the ‘‘Director of the Institute’’), shall develop a meta12 analysis of the available scientific data regarding the safe13 ty and health risks of smoking marijuana and the clini14 cally-proven effectiveness of smoking marijuana for medic15 inal purposes. 

16 (b) COMPLETION OF META-ANALYSIS; REPORT.—

17 Not later than 120 days after the date of the enactment 

18 of this Act, the Director of the Institute shall complete 

19 the meta-analysis under subsection (a) and submit to the 

20 Congress a report providing the meta-analysis. The Direc21 tor shall transmit a copy of the report to the Commis22 sioner of Food and Drugs. 

23 SEC. 3. DISSEMINATION OF META-ANALYSIS BY FOOD AND 

24 DRUG ADMINISTRATION. 

25 (a) PUBLIC ACCESS TO META-ANALYSIS THROUGH

26 INTERNET.—Not later than 30 days after receiving from 
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1 the Director of the Institute the report under section 2(b), 

2 the Commissioner of Food and Drugs shall post such re3 port on the Internet site of the Food and Drug Adminis4 tration. 

5 (b) DISSEMINATION OF META-ANALYSIS TO CERTAIN

6 PUBLIC HEALTH AGENCIES AND OTHER APPROPRIATE

7 ENTITIES.—Promptly after receiving from the Director of 

8 the Institute the report under section 2(b), the Commis9 sioner of Food and Drugs shall disseminate the report—

10 (1) to principal public health agencies of all 

11 States, including those that authorize the smoking of 

12 marijuana for medicinal purposes; and 

13 (2) to public health associations, health care 

14 professionals, and other appropriate entities that ad15 vocate or recommend the smoking of marijuana by 

16 patients for medicinal purposes. 

17 (c) DEFINITION.—As used in this section, the term 

18 ‘‘State’’ means each of the several States, the District of 

19 Columbia, the Commonwealth of Puerto Rico, the Com20 monwealth of the Northern Mariana Islands, American 

21 Samoa, Guam, the Virgin Islands, and any other territory 

22 or possession of the United States.

Æ