Policy Development and Guidance

Policy Development and Guidance to Industry

CDER's Division of Drug Marketing, Advertising and Communications (DDMAC) develops guidances to the industry on prescription drug advertising and promotional labeling issues. In addition, the division holds meetings with the regulated industry and other involved parties to discuss emerging issues, such as broadcast, direct-to-consumer, and Internet advertising, and use of cost effectiveness and quality of life claims in promotion. DDMAC communicates its interpretations of the regulations to the industry through guidance documents that are published in the Federal Register and made available to the public on the World Wide Web or from the Drug Information Branch, Division of Communications Management, HFD-210, CDER.

For guidance specific to a drug or therapeutic class, DDMAC works with the appropriate new drug review division to ensure that division's concerns are adequately addressed in the guidance.

Some of the Policies and Guidances Currently Under Development

Revision of Previous Guidances- DDMAC is revising all guidances it has issued since 1970 to determine if they are obsolete or need revision. A series of Federal Register notices will explain the changes and give the public an opportunity to comment.
Direct-to-consumer advertising and promotion- With other FDA offices, DDMAC is examining whether the current advertising and labeling regulations should continue to apply to promotion directed to consumers, or whether there should be changes made in the requirements for this type of promotion.
Promotion on the Internet- As part of an FDA working group, DDMAC is developing an agency-wide policy to address how advertising and promotion of FDA-regulated products will be regulated on the Internet.
Promotion to managed care organizations- DDMAC is developing a policy regarding pharmaceutical marketing, pharmacoeconomic claims, and information exchange in managed care environments.
Quality of Life Claims- DDMAC is developing a policy regarding the claims made in labeling and advertising about the impact of pharmaceuticals on the quality of life.