LD 1618
pg. 2
Page 1 of 3 PUBLIC Law Chapter 392 Page 3 of 3
Download Chapter Text
LR 487
Item 1

 
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


Page 1 of 3 Top of Page Page 3 of 3
Related Pages
  Search Bill Text Legislative Information
Bill Directory Search
Bill
Status
Session Information
119th Legislature Bills Maine Legislature

Office of Legislative Information
100 State House Station
Augusta, ME 04333
voice: (207) 287-1692
fax: (207) 287-1580
tty: (207) 287-6826
Word Viewer for Windows Disclaimer