Specifically, the "Extend the Reach Patient Starter Kit" .makes the following misleading statements:

	"Extend the Reach is designed to allow you to be part of a nationwide assessment of the impact of COMTAN® (entacapone) therapy on your quality of life."
	"In a recent survey, 1168 people with PD who took COMTAN along with their levodopa/carbidopa therapy reported improvements in their overall well-being and mood where compared with levodopa/carbidopa therapy alone."

These statements imply that Comtan therapy impacts patient quality of life, overall well-being, and mood, where these outcomes have not been demonstrated with substantial evidence from adequate and well-controlled studies using well-developed and validated measures.

We therefore object to the use of the claims above in "Extend the Reach: A Measurable Outcomes Program."   In addition, the program is misleading because it implies that the data will be used to assess the clinical benefit of Comtan therapy.   An uncontrolled study design is not able to produce adequate evidence to support a claim of clinical benefit.   To address this objection, we recommend that you do the following:

1. Immediately discontinue the use of the "Extend the Reach Patient Starter Kit" and any other promotional material with the same or similar messages.

2. Respond to this letter within ten days.  Your response should include a statement of your intent to comply with the above, a list of promotional materials with the same or similar issues, and your methods for discontinuing these promotional materials.

If you have any questions or comments, please contact me by facsimile at (301) 594-6759, or at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD42, Room 1713-23, 5600 Fishers Lane Rockville, MD 20857.   We remind you that only written communications are considered official.

Sincerely,

Elaine J. Hu, R.Ph. 
Regulatory Review Officer 
Evidence Review Branch 
Division of Drug Marketing, 
      Advertising, and Communications