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

CHAPTER 605

PRESCRIPTION DRUG ADVERTISING

§2700-A.__Prohibitions and required disclosures

1.__Definitions.__As used in this chapter, unless the context otherwise indicates, "clinical trial" means a clinical investigation as defined by the federal Food and Drug Administration that involves any experiment to test the safety or efficacy of a drug or biological product with one or more human subjects and 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.

2. Adoption of federal law and regulations by reference.__The department shall adopt rules to incorporate by reference federal statutes and regulations in 21 United States Code, Sections 331 and 352(n) and 21 Code of Federal Regulations, Part 202 and may adopt amendments to those statutes and regulations that are not inconsistent with those statutes and regulations.__Rules adopted pursuant to this subsection are routine technical rules as defined in Title 5, chapter 375, subchapter 2-A.

3. Misbranding and certain advertising prohibited.__A manufacturer may not present or cause to be presented an advertisement for a prescription drug in a television broadcast, radio broadcast or printed material that originates in this State, unless that advertisement meets the requirements of federal laws and regulations concerning misbranded drugs and devices and prescription drug advertising as adopted by reference by rule of the department pursuant to subsection 2.

4.__Disclosure of clinical trials. A manufacturer may not present or cause to be presented an advertisement for a prescription drug in a television broadcast, radio broadcast or printed material that originates in this State, unless the manufacturer has disclosed to the department, on a form provided by the department, the following information concerning any clinical trial of the prescription drug that the manufacturer has conducted or sponsored or is in the process of conducting or sponsoring:

A. The name of the entity that conducted or is conducting the clinical trial;