Digitas Health Advises on Latest FDA Guidance for Promotional Labeling
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By Mia Burns (mia.burns@ubm.com)
Following FDA’s release of a new draft guidance regarding the placement, size, and prominence of a prescription product’s name in advertising and promotional labeling, Digitas Health executives have provided recommendations for companies on how to proceed. The guidance was originally released as a draft in January 1999. A final version was presented in January 2012. The new draft guidance included some significant changes from the previous versions, and largely retracts many of the problematic aspects of the earlier versions, according to the Digitas Health regulatory alert.
Digitas Health Vice President/Group Director of Regulatory Review Dale Cooke told Med Ad News Daily, “I really applaud them for having gotten out this new draft guidance so rapidly because when you think about FDA time in terms of developing a guidance, it is not a small thing. This really basically happened in about a year and a half. I think that the main reason for it was to have guidance formally out in the public that better reflected FDA’s actual position than the previous guidance from January 2012.”
In his regulatory alert, Cooke advises companies to take the following actions in light of the most recent draft guidance: Ensure that new materials being developed take into account this new guidance; review existing materials as they expire for compliance with this guidance; and 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.
“FDA as a rule of thumb does not expect companies to be able to turn on a dime,” Cooke says. “They understand that there is a time frame to get materials developed and to get things out into the public domain. They understand that if they provide new guidance that changes things that it is going to take time for those changes to filter through all of your communications rather than trying to just instantly stop everything.”
Cooke also told Med Ad News Daily, “What we recommend is just as things come through the pathway, look at it at in light of this new guidance, first of all so that you can gradually get into compliance over the course of time, and then traditionally materials have a one-year expiration date, so the one-year expiration date gives you a natural time when something comes up for review you would just revise it in light of the new guidance as opposed to trying to retract everything that is out there and implement the changes in it.”
According to the Code of Federal Regulations, “the established name [the generic name], if such there be, corresponding to such proprietary name or designation shall accompany such proprietary name or designation each time it is featured in the advertisement for the drug.” In addition, regulations require that “[o]n any page of an advertisement” if the brand name “is not featured but is used in the running text” (or body copy) of the advertisement, then the established name must accompany the brand name “at least once.”
The new draft guidance also differs from the 2012 finalized guidance in three principal matters, according to the Digitas Health regulatory alert. The first matter is that FDA intends to exercise enforcement discretion regarding its expanded definition of what constitutes a featured use of a brand name, i.e. FDA will not enforce the requirement to provide the generic name with every featured use of a brand name. Secondly, FDA intends to exercise enforcement discretion “if the established [generic] name is not included in the audio portion” of television commercials. Thirdly, 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 generic “name accompanies the proprietary name at least once per Web page or screen.”
However, there are areas in which Cooke wishes that FDA would have provided additional clarity within the draft guidance around the context of certain types of communications, such as text messages, tweets, or other very short formats, as some brand plus generic names are very long. “If I, for example, am sending out a text message to a patient who is already on therapy reminding them to take their meds, it would be nice if it were possible to not have to include the generic name in that communication,” he told Med Ad News Daily.
Digitas Health executives are already working with clients on the revised draft guidance. “We have a unique relationship with our clients, not just because we’re an AOR, but also because we already have this regulatory specialty in-house that our clients will look for us and rely upon us to keep them apprised of these types of things,” Cooke says. “We try to provide that service to help out our clients to keep on top of the latest changes, and especially in area like this where we saw what happened in January of last year when that guidance was finalized quite unexpectedly and we saw that it took several months of us working with our clients to work through it.”
Following FDA’s release of a new draft guidance regarding the placement, size, and prominence of a prescription product’s name in advertising and promotional labeling, Digitas Health executives have provided recommendations for companies on how to proceed. The guidance was originally released as a draft in January 1999. A final version was presented in January 2012. The new draft guidance included some significant changes from the previous versions, and largely retracts many of the problematic aspects of the earlier versions, according to the Digitas Health regulatory alert.
Digitas Health Vice President/Group Director of Regulatory Review Dale Cooke told Med Ad News Daily, “I really applaud them for having gotten out this new draft guidance so rapidly because when you think about FDA time in terms of developing a guidance, it is not a small thing. This really basically happened in about a year and a half. I think that the main reason for it was to have guidance formally out in the public that better reflected FDA’s actual position than the previous guidance from January 2012.”
In his regulatory alert, Cooke advises companies to take the following actions in light of the most recent draft guidance: Ensure that new materials being developed take into account this new guidance; review existing materials as they expire for compliance with this guidance; and 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.
“FDA as a rule of thumb does not expect companies to be able to turn on a dime,” Cooke says. “They understand that there is a time frame to get materials developed and to get things out into the public domain. They understand that if they provide new guidance that changes things that it is going to take time for those changes to filter through all of your communications rather than trying to just instantly stop everything.”
Cooke also told Med Ad News Daily, “What we recommend is just as things come through the pathway, look at it at in light of this new guidance, first of all so that you can gradually get into compliance over the course of time, and then traditionally materials have a one-year expiration date, so the one-year expiration date gives you a natural time when something comes up for review you would just revise it in light of the new guidance as opposed to trying to retract everything that is out there and implement the changes in it.”
According to the Code of Federal Regulations, “the established name [the generic name], if such there be, corresponding to such proprietary name or designation shall accompany such proprietary name or designation each time it is featured in the advertisement for the drug.” In addition, regulations require that “[o]n any page of an advertisement” if the brand name “is not featured but is used in the running text” (or body copy) of the advertisement, then the established name must accompany the brand name “at least once.”
The new draft guidance also differs from the 2012 finalized guidance in three principal matters, according to the Digitas Health regulatory alert. The first matter is that FDA intends to exercise enforcement discretion regarding its expanded definition of what constitutes a featured use of a brand name, i.e. FDA will not enforce the requirement to provide the generic name with every featured use of a brand name. Secondly, FDA intends to exercise enforcement discretion “if the established [generic] name is not included in the audio portion” of television commercials. Thirdly, 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 generic “name accompanies the proprietary name at least once per Web page or screen.”
However, there are areas in which Cooke wishes that FDA would have provided additional clarity within the draft guidance around the context of certain types of communications, such as text messages, tweets, or other very short formats, as some brand plus generic names are very long. “If I, for example, am sending out a text message to a patient who is already on therapy reminding them to take their meds, it would be nice if it were possible to not have to include the generic name in that communication,” he told Med Ad News Daily.
Digitas Health executives are already working with clients on the revised draft guidance. “We have a unique relationship with our clients, not just because we’re an AOR, but also because we already have this regulatory specialty in-house that our clients will look for us and rely upon us to keep them apprised of these types of things,” Cooke says. “We try to provide that service to help out our clients to keep on top of the latest changes, and especially in area like this where we saw what happened in January of last year when that guidance was finalized quite unexpectedly and we saw that it took several months of us working with our clients to work through it.”
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