Executive Briefing Series (formerly The Food & Drug Letter)

The FDA’s 2011 reorganization, renaming and elevation of the Division of Drug Marketing, Advertising and Communications (DDMAC) into the Office of Prescription Drug Promotion (OPDP), indicated that the agency was bringing new tools and a more energized force to fight drug promotion violations. While pharmaceutical companies haven’t seen so much as a major change in enforcement, they have been the focus of better efforts to communicate what’s expected of them to stay within the FDA’s good graces regarding drug promotions. Plus, many more guidances and regulations have been promised by the agency. This issue of The Food & Drug Letter looks at actions during the past year since the change, spotlights the most important aspects of good drug promotion practices and profiles a few companies recently cited with violations.

In September 2011, the FDA reorganized and renamed DDMAC, the Division of Drug Marketing, Advertising and Communications, as OPDP, the Office of Prescription Drug Promotion, and elevated the Office in the FDA chain of command.

Drugmakers’ omissions or minimizations of product risks are the leading cause of FDA enforcement letters for advertising, accounting for 70 of the 120 letters sent to pharma companies since 2009, experts say.

Drug and medical device companies increasingly are minimizing or omitting the risks associated with their products in advertising and promotional materials, an FDA official says.

A final FDA guidance addressing different advertising mediums, including TV and the web, will help drugmakers determine when and how the active ingredient, or established name, of a drug should accompany the brand name.

A sharp increase in exaggerated or misleading comparative claims in drug advertisements has the FDA analyzing the issue and considering guidance to help stop the violations.

Drugmakers with drugs or biologics under FDA review for accelerated approval should submit promotional materials to the agency while the drug is under review if they plan to use the launch materials within 120 days of approval.

Ferring Pharmaceuticals has been handed an FDA untitled letter for overstating the efficacy and indication of its injectable prostate cancer drug Firmagon in a recent sales aid.

Drugmakers could see a more forceful crackdown on off-label promotion, says a new Office of Inspector General (OIG) report that directs HHS to focus on the practice.

Novartis’ use of case studies in cancer drug Gleevec’s advertising material is misleading because one patient’s experience does not count as substantial evidence, the FDA says.

The FDA issued an untitled letter to Validus Pharmaceuticals claiming the drugmaker’s website published misleading claims for its bipolar disorder drug Equetro.

The FDA needs more time to make a decision about whether risk/benefit information should be added to prescription drug promotional labeling or advertising, the agency said in a recent report to Congress.