2004D-0042 - Draft Guidance for Industry on Improving Information About Medical Products and Health Conditions; Withdrawal; Availability
FDA Comment Number : EC12
Submitter : Mr. Don Bell Date & Time: 09/16/2004 06:09:17
Organization : National Association of Chain Drug Stores
Drug Association
Category :
Issue Areas/Comments
August 10, 2004

Division of Dockets Management
5630 Fishers Lane
Room 1061
Rockville, MD 20852

RE: Docket No. 2004D-0042 ? Guidance for Industry, Brief Summary, Disclosing Risk Information in Consumer-Directed Print Advertisements ? Reopening of Comment Period

The National Association of Chain Drug Stores (NACDS) offers additional comments regarding the release by the Food and Drug Administration (FDA) of the Guidance for Industry, Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (the ?Draft Guidance?). The Draft guidance provides suggestions to manufacturers regarding the communication of risk information to consumers in print advertisements for prescription drugs.

In its original comments, NACDS asked FDA to consider the special role community pharmacies have in providing and disseminating healthcare information to consumers. Others have commented in support of NACDS? position, including the National Consumers League and Catalina Health Resource. NACDS reiterates its request that FDA:

? Clarify the language of the Draft Guidance as it relates to in-pharmacy communications.
? Exempt retail pharmacies from these communication requirements.
? Recognize that the following pharmacy communications constitute treatment, not marketing, and therefore should not have to include a brief summary or full prescription drug package insert:
o Refill reminders;
o Therapeutic interchange;
o Coverage and formularies;
o Counseling and drug utilization review, including educational information about the importance of compliance with and adherence to the prescription drug regimen a physician has prescribed; and
o Disease state management and wellness programs, including information about therapies that complement the prescribed drug therapy.

Because these communications should not be regulated by FDA, NACDS does not believe that FDA should address these communications in a separate guidance. Communications between pharmacists and their patients are regulated by state boards of pharmacy and are further restricted by professional standards of practice. Additional federal guidance would be unnecessary and could be contradictory.

Thank you for considering our comments. Please contact me at (703) 837-4231 if you have any questions or comments.


Don L. Bell, II
General Counsel