C. The dates during which the trial has taken place;

D. Information concerning the results of the clinical trial, including potential or actual adverse effects of the drug; and

E. Any other information determined by the commissioner to be relevant.

This subsection applies to clinical trials commenced on or after October 15, 2005.

5. Immunity.__Notwithstanding any other provision of law to the contrary, a person who is required or authorized by the commissioner to report, receive or disclose information pursuant to this chapter is immune from liability for reporting, receiving or disclosing that information in accordance with the provisions of this chapter or any rule adopted pursuant to this chapter.

6. Penalties.__A violation of this chapter is a violation of the Maine Unfair Trade Practices Act, for which a fine of not more than $10,000 may be adjudged.__Each day a manufacturer is in violation of this chapter is considered a separate violation.

7.__Fee.__For each prescription drug advertised in a television broadcast, radio broadcast or printed material that originates in this State, the drug's manufacturer shall pay a fee to the department, determined by the department by rule and not to exceed $500, to offset the cost of implementing and maintaining a clinical trial database.__Rules adopted pursuant to this subsection are routine technical rules as defined in Title 5, chapter 375, subchapter 2-A.

Sec. 2. Commissioner of Health and Human Services to provide access to clinical trial information. The Commissioner of Health and Human Services shall maintain a database of clinical trial information provided pursuant to the Maine Revised Statutes, Title 22, section 2700-A and to the extent permissible under federal law shall provide access to the public to that information through an Internet website. The commissioner may adopt rules to implement the purposes of this section. Any rules adopted pursuant to this section are routine technical rules as defined in Title 5, chapter 375, subchapter 2-A.

SUMMARY

This bill requires the Department of Health and Human Services to adopt rules incorporating by reference federal laws