Jul 20, 2009
The much anticipated release of May’s DDMAC’s Draft Guidance for Industry leaves brand managers and pharma marketers with little guidance around paid search advertising. Despite the FDA issuing 40 warning letters in April to various brands related to their paid search ads, the new guidance draft document focuses on print and broadcast advertising – with a mere mention of internet websites in a footnote on page 3.
The FDA’s guidelines clearly state that the brand name and treatment indication cannot appear together without fair balance. However, the character limit for online search text ads (95 characters or less) prohibits the advertiser from including fair balance, making branded product claims impossible to execute. Black box products are subject to even tighter regulations.
Roska Healthcare Advertising posed some hypothetical situations to DDMAC to obtain further clarification. While DDMAC stated that it generally does not comment on hypothetical scenarios, we were able to gather several “insights” into their present state of mind
- DDMAC has not categorized search ads as either advertising or promotion labeling
- If an advertisement/promo labeling makes “any representation/claims” then there must be risk information “in each part”
- In general, search ads that mention the name of a drug without an indication are acceptable, however ads for drugs w/ black box warnings have additional restrictions