More New Guidance from FDA: Brand and Generic Name Treatment
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.
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)].
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:
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”