Nov. 25, 2013 – The FDA published a Federal Register notice (2013-27770 (1)) on Nov. 20 regarding the availability of new draft guidance on product name placement, size and prominence in advertising and promotional labeling. Dale Cooke, Vice President of Regulatory Review at Digitas Health, sat down with the Coalition for Healthcare Communication to talk about the key changes made by the agency in this new guidance, which revises a January 2012 guidance document that set out to update a 1999 draft document on the matter.

Coalition: Can you describe the positive changes that the Nov. 20 draft guidance made to the version issued in January 2012?

Cooke: The new draft guidance differs from the 2012 finalized guidance in three ways: (1) The agency states that it intends to exercise enforcement discretion regarding its expanded definition of what constitutes a featured use of a brand name; (2) The FDA intends to exercise enforcement discretion “if the established [generic] name is not included in the audio portion” of television commercials; and (3) The FDA has changed its understanding  of the need for the generic name in electronic promotion from a requirement of “once per screen” to a requirement that the generic name “accompanies the proprietary name at least once per Web page or screen.”

Coalition: Why are these changes significant?

Cooke: The 2012 finalized guidance sort of came out of the blue. It was never listed as something the agency was actively working on and no one was expecting it. When it did come out, some of the changes were major, and I am not sure FDA thought through all of the implications. For example, the 2012 guidance expanded the definition of “featured use,” which in the advertising world would be interpreted as something like using a starburst in ad promo content. However, the guidance stated that any use that’s not running text is a featured use. Trying to shoehorn some of these generic names into promotional presentations was difficult, ugly, and worst of all, confusing to the consumer, who was just interested in seeing a product’s side effects but had to wade through the Latinate phrases. This got even more confusing as marketers expanded into additional communication channels.

Coalition: Didn’t Office of Prescription Drug Promotion Director Tom Abrams state at an industry meeting that companies didn’t have to use the generic name every time?

Cooke: Yes. Abrams spoke at a DIA meeting and remarked that the FDA was not saying that companies had to include the generic name in every place. However, his remarks were not a total solution, because they were not bankable. Anyone who has not heard the remarks or seen the reports in the trade press at that time has had to rely on what the guidance states. The Nov. 20 draft guidance is a needed move by FDA and we ought to give them credit because it took less than two years for them to issue it and focus on fixing concerns created by the 2012 document.  

Coalition: Are there problem areas that the new draft guidance does not address?

Cooke: As I look through the guidance, I guess I would have preferred that they curtailed the definition of featured use beyond any mention of the drug that wasn’t in running text. And, not that the new guidance is lacking, but I thought they’d say more about electronic and digital communications such as multi-screen and smaller screen experiences and text messages. For example, is it okay if I am doing a medication reminder program and I say “remember to take your ‘brand name’” or do I have to say “remember to take your “brand name (generic name)”? This may not seem like much of a concern if the generic name is short, but there are combination products and those with four separate constituent parts out there.  

I would not consider a medication reminder message to be a featured use of a brand name. If FDA wants companies to do these reminder services – which significantly improve medication adherence – I would hope that this guidance would not stop them. I don’t think that it was FDA’s intention, but it’s not clear. I wish they had addressed this. I also wish they had used this opportunity to say more about the applicability of the regulations to screens. The FDA is not being ignorant or backward on this, but they are acknowledging by omission the complexities of this issue because the regulations did not foresee how, in 2013, we would have two or three devices on our desks at one time.Coalition: Do you think the FDA refrained from tackling this because its social media guidance is not out yet?

Cooke: They could tackle this issue in many different guidance documents. The nature of how people are interacting with healthcare information is rapidly changing. Recently I was talking to a group about the final guidance on the adequate provision requirement in direct-to-consumer broadcast advertising, specifically the notion that there needs to be a print version of every ad – either leaflets issued throughout the community or magazine ads. I asked sort of rhetorically whether, when The New Yorker is the last magazine still being printed, will every pharmaceutical company advertising its products be buying ads in that magazine? We could very easily argue that every library has an Internet connection and that consumers are more likely to sit at a computer terminal to learn about treatments than they would be to go over to the magazine section and randomly leaf through magazines in search of information about their condition.

Coalition: Is there other FDA guidance where more information about “screen” promotion would be valuable?

Cooke: There is also 2009 guidance on presenting risk information that divided promotional material into two formats: print and non-print. So even though a TV spot, a radio commercial, a text message and a Website are different, they are all just lumped together. I think there are relevant considerations for electronic/digital channels that are different and that having them all in a non-print clump is a mistake. The FDA is still actively working on that guidance and it would serve as another opportunity for it to revisit that issue, especially for mobile-accessible Websites, mobile apps, adherence text messages, etc. These are areas where it would be fantastic to get some guidance from the FDA. In the absence of this, clients are developing their own policies.

Coalition: How should industry approach generic name placement now that the new draft guidance has been issued?

Cooke: In light of this new guidance, Digitas Health recommends that companies: (1) Ensure that new materials being developed take into account this new guidance; (2) Review existing materials as they expire for compliance with this guidance; and (3) Revisit any internal guidelines for presentations of product name in electronic promotional items and television commercials, especially those that were developed or revised in light of the 2012 guidance on this topic.

Whenever you have an area with ongoing FDA activity and changes in position – you want to make sure it’s disseminated throughout the company. If you are a small company with one product and a limited marketing staff, you may only have a small group of folks responsible for this. But in moderate or large companies with multiple marketing teams and regulatory reviewers, you really need to go out of your way to make sure everyone is aware of the new position and is on board with the same approach. This is not a trivial issue. Companies should take advantage of quarterly meetings, they can issue memos, or they can share my recent regulatory alert (185400017-DH-Regulatory-Alert-2013-Product-Name-Usage-Guidance). Getting ads approved is an already time-consuming process, and I would hate to see it get bogged down in something as relatively basic as this.