More New Guidance from FDA: Brand and Generic Name Treatment

Introduction
On January 24 FDA issued new, final guidance on “product name placement, size, and prominence in advertising and promotional labeling.” I can tell you up front this still isn't the long-awaited social media guidance. Instead, the document sets out to clarify FDA requirements and expectations for how and when brand names and generic names should appear in promotional advertising.

Channels/Media Addressed
The guidance applies to all channels and it specifically calls out traditional print, audio-visual, broadcast, and “electronic and computer-based” ads and “Internet promotion” such as “social media, e-mails, CD-ROMs, and DVDs.”

Types of Products to Which this Applies

• It applies to prescription human drugs, including biologicals, and prescription animal drugs.
• It also clarifies direction based on if the product is made up of one active ingredient [example: PRODUCT (generic ingredient)] or more than one active ingredient [example:   PRODUCT (ingredient 1 and ingredient 2)].

Issues Addressed
Overall the document addresses the juxtaposition and treatment of how the generic name (“established” ) name should appear in relation to the brand (“proprietary”) name, including:

• placement
• size
• prominence
• frequency

Implications
We will be digging into it and providing more analysis soon .... Is it a big "no new news here," or is it a "holy crap, it's time to review all our promo materials pronto!"?

Meantime, if you plan on reading it, here's a helpful translation for key terms from FDA-speak to marketing-speak:

• Proprietary = brand name
• Established = generic name
• Running text = main body copy “the body of text in a piece as distinct from headlines, taglines, logos, footnotes, graphs, or pictures”

Stay tuned!http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070076.pdf