HB 1230-FN – AS INTRODUCED
2006 SESSION
01/04
HOUSE BILL 1230-FN
AN ACT relative to clinical trials for pharmaceuticals.
SPONSORS: Rep. Matarazzo, Hills 20; Rep. Cloutier, Sull 4; Rep. P. Allen, Ches 6; Rep. Pilliod, Belk 5
COMMITTEE: Health, Human Services and Elderly Affairs
This bill requires the commissioner of the department of health and human services to make public certain data on clinical drug 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Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
06-2357
01/04
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Six
AN ACT relative to clinical trials for pharmaceuticals.
Be it Enacted by the Senate and House of Representatives in General Court convened:
1 New Subdivision; Clinical Drug Trials. Amend RSA 126-A by inserting after section 62 the following new subdivision:
126-A:63 Definitions. In this subdivision:
I. “Clinical trial” means a clinical investigation as defined by the Food and Drug Administration that involves any trial to test the safety or efficacy of a drug or biological product with one or more human subjects and that is intended to be submitted to, or held for inspection by, the Food And Drug Administration as part of an application for a research or marketing permit.
II. “Manufacturer” means a manufacturer of prescription drugs or biological products or an affiliate of the manufacturer.
III. “Labeler” means an entity or person that receives prescription drugs or biological products from a manufacturer or wholesaler and repackages those drugs or biological products for later retail sale and that has a labeler code from the Food and Drug Administration under 21 C.F.R. section 207.20.
126-A:64 Disclosure of Clinical Trials of Prescription Drugs. A manufacturer or labeler of prescription drugs dispensed in this state shall post, with regard to those prescription drugs, on the publicly accessible Internet website of the National Institutes of Health or its successor agency or another publicly accessible website the following information concerning any clinical trial that the manufacturer conducted or sponsored on or after October 15, 2005:
I. The name of the entity that conducted or is conducting the clinical trial;
II. A summary of the purpose of the clinical trial;
III. The dates during which the trial has taken place; and
IV. Information concerning the results of the clinical trial, including potential or actual adverse effects of the drug.
126-A:65 Publication of Information; Rulemaking. The commissioner shall make available on the appropriate state health-related websites information directing citizens of New Hampshire to publicly available information, as required under RSA 126-A:64, on clinical drug trials and other clinical studies including those sponsored by the National Institutes of Health and those sponsored by the private sector, such as the Pharmaceutical Research and Manufacturers of America. The commissioner may adopt rules, pursuant to RSA 541-A, relative to the procedures for making the information required under this section publicly available.
2 Effective Date. This act shall take effect 60 days after its passage.
LBAO
06-2357
11/7/05
HB 1230-FN - FISCAL NOTE
AN ACT relative to clinical trials for pharmaceuticals.
FISCAL IMPACT:
The Legislative Budget Assistant has determined that this legislation has a total fiscal impact of less than $10,000 in each of the fiscal years 2006 through 2010.