July 30, 2007

Legislative Activity


From:
American Advertising Federation
American Association of Advertising Agencies
Association of National Advertisers
National Cable & Telecommunications Association
National Newspaper Association

To:
The Honorable John Dingell
The Honorable Joe Barton
The Honorable Edward M. Kennedy
The Honorable Mike Enzi

Letter to FDA Reauthorization Conference Committee on Marketing Restrictions in Bill


We are writing to urge you to remove the “Marketing Plan” provision from the Risk Evaluation and Mitigation Strategy in S. 2900 as you deliberate in conference with the Senate on these issues.

This provision would authorize the Food and Drug Administration (FDA) to require a company to submit information regarding its marketing plan and practices for a drug. While the requirement has been modified with a rule of construction stating it does not authorize the secretary to make or direct changes in the marketing plan, this is an unprecedented intrusion into a company’s exercise of the right to engage in commercial speech protected under the First Amendment. Moreover, the FDA lacks the resources or the expertise to undertake an examination of the marketing programs of companies. This would substantially exceed the current responsibilities for examining advertising prepared by pharmaceutical companies.

We also are concerned that confusion during the committee markup of the bill may have precluded a full examination of the problems that would be involved with its implementation.

We appreciate your consideration of our request and hope that you are able to leave this issue for a closer examination at a future time.

Respectfully,

American Advertising Federation
American Association of Advertising Agencies
Association of National Advertisers
National Cable & Telecommunications Association
National Newspaper Association