Regulatory Focus™ > News Articles > FDA Pledges Enforcement Discretion in Revised Guidance on Labeling

FDA Pledges Enforcement Discretion in Revised Guidance on Labeling

Posted 18 November 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has announced the release of its long-awaited draft guidance on the placement, size and prominence of a product's name in advertising and promotional labeling, a development nearly two years in the making.


The guidance document was first released in January 2012 in final form, part of what FDA said was an effort to clarify the requirements (last issued in 1999) surrounding one of the most visible and important aspects of a product: its name.

Under current regulations, a branded product must bear both its brand name and its universally recognized generic name. For example, labeling for Pfizer's Viagra would contain both the brand name (Viagra) and its generic name (sildenafil), with each required to be in specific proportion to one another.

FDA's 2012 draft guidance specifies that the generic name needs to be at least half the size of the proprietary name when it is placed in the headline or otherwise outside of the "running text" (any text distinct from headlines, taglines, logos, footnotes, graphs or pictures), and that this text size must reflect the actual size of the text. Upper-case letters would thus be looked at differently than lower-case letters in the same point font.

Issues Abound in Previous Guidance

But as Dale Cooke, vice president of regulatory review at Digitas Health and a noted expert on promotion and labeling issues explained in a primer for the Food and Drug Law Institute (FDLI) last year, the guidance contained several major deviations from the 1999 guidance.

The first, Cooke explained, was that the guidance required companies to feature the generic name of the product much more frequently-"each time [the proprietary name] is featured"-in its advertising. At present, while the generic name typically accompanies the brand name at its featured use (i.e. not in the body copy), the guidance would have required it to be used at every other instance, such as in sidebar links in a webpage ("About Viagra," "Common Side Effects of Viagra," etc).

And while that might not be a big deal if your generic name is "Sildenafil," it's a more difficult proposition if your drug's name is "Aliskiren Hemifumarate; Amlodipine Besylate; Hydrochlorothiazide" (Amturnide, Novartis).

Another issue identified by Cooke was that the guidance changed its definition of what a "page" is on electronic media. FDA recommended that the proprietary name be used at least once per screen for text that spans multiple pages. The problem: How does one define a screen? The screen size of a mobile device is different than that of a desktop monitor, Cooke observed.

"The final guidance does not specify how to understand 'per screen,'" he explained.

Enforcement Discretion-Based Approach

The release of the guidance was met with considerable consternation in industry, which said the guidance had done more to confuse than clarify. In the wake of those concerns, Tom Abrams, director of the Office of Prescription Drug Promotion (OPDP), said his office would not require the generic name to be repeated in every instance so long as it was contained in the most prominent use of the name. Finally, Abrams reportedly said his agency would define "screen" as what would be printed out on an 8.5" by 11" piece of paper.

FDA is now out with a draft revision to its previously final guidance seemingly aimed at placating industry's concerns by pledging the use of "enforcement discretion" in certain cases.

Most notably: "Although the regulations state that the established name 'shall accompany such proprietary name . . . each time it is featured,' in exercising its enforcement discretion, FDA does not intend to object provided that the established name accompanies the proprietary name at least once per page or spread where the proprietary name most prominently appears on the page or spread."

In another example, FDA said it "does not intend to object if sponsors disclose the established name in direct conjunction with the most prominent presentation of the proprietary name [broadcast advertisements]."

And elsewhere, FDA clarifies that the generic name will only need to accompany the branded name "at least once" in the running text if there is no featured instance of the name. Even then, the name should be listed at least once per page if the text spans multiple pages.

However, contrary to Abrams' remarks, FDA did not clarify what "page" meant for the purposes of electronic media, saying only that it "does not intend to object provided that the established name accompanies the proprietary name at least once per web page or screen."

FDA will be accepting comments on the guidance, but no date has yet been made public for those comments to be submitted by.


Cooke said he was pleased in his initial read-through of the guidance, noting that its enforcement discretion provisions seemed to "largely address the concerns raised by industry that the final guidance went way too far in expanded the use of the generic (established) name."

Cooke, however, said he was disappointed that FDA made no attempt to define "Screen size" in the guidance.

"This new draft guidance simply retreats from that entire issue, by simply encouraging the use of the generic name in the most prominent location," Cooke noted. "That's a better position than the 'once per screen' position of the 2012 guidance, but it doesn't provide any new guidance or direction for industry about how to deal with other challenges of a multi-screen world. I was hopeful that we might be able to apply the lessons of this guidance to things such as provision of the PI or the presentation of risk information."

Draft Guidance for Industry Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling

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