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First Special Session of the 122nd

H.P. 1141 - L.D. 1618

An Act Regarding Advertising by Drug Manufacturers and Disclosure of Clinical Trials

Be it enacted by the People of the State of Maine as follows:

     Sec. 1. 22 MRSA c. 605 is enacted to read:


§2700-A. Prohibitions and required disclosures

     1. Definitions. As used in this chapter, unless the context otherwise indicates, the following terms have the following meanings.

     2. Regulated advertisement requirement. Beginning October 15, 2005, a manufacturer may not present or cause to be presented in the State a regulated advertisement, unless that advertisement meets the requirements concerning misbranded drugs and devices and prescription drug advertising of federal law and regulations under 21 United States Code, Sections 331 and 352(n) and 21 Code of Federal Regulations, Part 202 and state rules.

     3. Disclosure of clinical trials of prescription drugs. Beginning October 15, 2005, a manufacturer or labeler of prescription drugs that is required to report marketing costs for prescription drugs pursuant to section 2698-A shall post, with regard to those prescription drugs, on the publicly accessible Internet website of the federal 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, 2002:

In order to satisfy the requirements of this subsection, the publicly accessible website and manner of posting must be acceptable to the department.

     4. Fees. Beginning April 1, 2006, each manufacturer of prescription drugs that are provided to Maine residents through the MaineCare program under section 3174-G or the elderly low-cost drug program under section 254 shall pay a fee of $1,000 per calendar year to the department. Fees collected under this subsection must be used to cover the cost of overseeing implementation of this section, including but not limited to maintaining links to publicly accessible websites to which manufacturers are posting clinical trial information under subsection 3 and other relevant sites, assessing whether and the extent to which Maine residents have been harmed by the use of a particular drug and undertaking the public education initiative under subsection 5. Revenues received under this subsection must be deposited into an Other Special Revenue Funds account to be used for the purposes of this subsection.

     5. Public education initiative. The department shall undertake a public education initiative to inform residents of the State about clinical trials and drug safety information.

     6. Penalties. A violation of this section is a violation of the Maine Unfair Trade Practices Act. Each day a manufacturer is in violation of this chapter is considered a separate violation.

     7. Rulemaking. The department may adopt rules to implement this section. Rules adopted pursuant to this subsection are routine technical rules as defined in Title 5, chapter 375, subchapter 2-A.

     Sec. 2. Report. By January 15, 2007, the Department of Health and Human Services shall report to the joint standing committee of the Legislature having jurisdiction over health and human services matters regarding compliance with the Maine Revised Statutes, Title 22, section 2700-A, the completeness and ease of public access to information provided by the drug manufacturers and the need for further action or legislation.

Effective September 17, 2005.

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