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:
PRESCRIPTION DRUG ADVERTISING
§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.
A. "Clinical trial" means a clinical investigation as defined by the federal 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 federal Food and Drug Administration as part of an application for a research or marketing permit.
B. "Manufacturer of prescription drugs" or "manufacturer" means a manufacturer of prescription drugs or biological products or an affiliate of the manufacturer or a labeler 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 federal Food and Drug Administration under 21 Code of Federal Regulations, 2027.20 (1999).
C. "Regulated advertisement" means the presentation to the general public of a commercial message regarding a prescription drug or biological product by a manufacturer of prescription drugs that is:
(1) Broadcast on television or radio from a station that is physically located in the State;
(2) Broadcast over the Internet from a location in the State; or
(3) Printed in magazines or newspapers that are printed, distributed or sold in the State.
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:
A. The name of the entity that conducted or is conducting the clinical trial;
B. A summary of the purpose of the clinical trial;
C. The dates during which the trial has taken place; and
D. Information concerning the results of the clinical trial, including potential or actual adverse effects of the drug.
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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