SB 311-FN – AS INTRODUCED
2006 SESSION
01/04
SENATE BILL 311-FN
AN ACT relative to disclosure of the results of clinical trials.
SPONSORS: Sen. Barnes, Dist 17; Sen. Larsen, Dist 15; Sen. Fuller Clark, Dist 24
COMMITTEE: Health and Human Services
This bill requires the commissioner of the department of health and human services to adopt rules establishing standards for the approval of clinical trials within New Hampshire. Under this bill, drug manufacturers shall publicly disclose the results of clinical trials.
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Explanation: Matter added to current law appears in bold italics.
Matter removed from current law appears [in brackets and struckthrough.]
Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
06-2862
01/04
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Six
AN ACT relative to disclosure of the results of clinical trials.
Be it Enacted by the Senate and House of Representatives in General Court convened:
1 New Paragraph; Clinical Trials. Amend RSA 126-A:5 by inserting after paragraph XIII the following new paragraph:
XIV. The commissioner shall adopt rules, pursuant to RSA 541-A, establishing minimum standards for the approval of clinical trials within this state. The standards shall ensure that, prior to approval of a clinical trial, drug manufacturers shall register the trial on a federal public registry and shall agree to make public the result of the clinical trial.
2 Effective Date. This act shall take effect 60 days after its passage.
LBAO
06-2862
Revised 12/22/05
SB 311 FISCAL NOTE
AN ACT relative to disclosure of the results of clinical trials.
FISCAL IMPACT:
The Department of Health and Human Services states this bill will increase state expenditures by an indeterminable amount in FY 2006 and each year thereafter. There will be no fiscal impact on state, county and local revenue or county and local expenditures.
METHODOLOGY:
The Department indicated this bill requires the Department to adopt rules establishing standards for the approval of clinical trials in New Hampshire. The rules will ensure drug manufacturers register the trial on a federal public registry and requires the manufacturer to agree to make the results public. The Department assumes it would be required to monitor the drug trails and enforce the provisions of the administrative rules. The Department cannot project the volume of drug trials or determine the level of monitoring and enforcement that will be necessary.