BILL REQ. #:  S-0712.3 

Read first time 02/18/2005.   Referred to Committee on Health & Long-Term Care.

     AN ACT Relating to public disclosure of clinical trials; adding a new section to chapter 42.17 RCW; and creating a new section.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:

NEW SECTION.  Sec. 1   The legislature finds that physicians and patients are not always aware of, and do not always have access to, available information concerning human clinical trials involving emerging drugs. Recent news stories have highlighted the problems associated with certain antidepressant and arthritis drugs already available by prescription, but the information concerning the clinical trials of these drugs has not been made widely available by the United States food and drug administration. It is the intent of the legislature to require public institutions in this state that take part in human clinical trials of drugs to release complete results of the clinical trials.

NEW SECTION.  Sec. 2   A new section is added to chapter 42.17 RCW under a new subchapter heading entitled "miscellaneous disclosure requirements" to read as follows:
     (1) For the purposes of this section, "drugs" has the same meaning as defined in 21 U.S.C. Sec. 321(g)(1) and (p) of the federal food, drug, and cosmetic act (21 U.S.C. Sec. 301 et seq.).
     (2)(a) Any state-funded public institution in this state that takes part in human clinical trials of drugs must post a summary of the clinical trials, in a timely manner, on the institution's web site.
     (b) The summary must be presented in a format normally acceptable by academic journals for peer review. The summary must inform the reader that the full contents of the study are available to the public under the provisions of this chapter. A summary must include the following information in its title: (i) "Official disclosure"; (ii) the name of the drug; and (iii) the name of the state-funded public institution.