CHAPTER 392

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:

CHAPTER 605

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).