Healthy Skepticism Library item: 17556
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Electronic Source
Silverman E
Is The FDA Proposal For DTC Ads Too Vague?
Pharmalot 2010 Apr 2
http://www.pharmalot.com/2010/04/is-the-fda-proposal-for-dtc-ads-too-vague/
Full text:
The FDA has proposed a new rule to amend its direct-to-consumer regulations covering broadcast ads and would require info about side effects and contraindications to be presented in a “clear, conspicuous and neutral manner.” The requirements are:
The DTC ad must have “language that is readily understandable by consumers;” audio info must be understandable, referring to volume, articulation and pacing; text info must be placed appropriately and on a contrasting background long enough and in lettering that is easily read; and the ad shouldn’t include “distracting representations,” such as statements, text, images, sound or a combination that would detract from communicating the “major statement.”
What, exactly, is language that is readily understandable by consumers? The FDA may allow for some creativity in meeting requirements, according to The Pink Sheet, while Bob Ehrlich of DTC Perspectives suggests the FDA will be under pressure to be tough. The FDA Law blog believes the definition is simply too vague.
In any event, the FDA cites a May 2009 draft guidance for presenting risk info and offers an example. “If a drug’s approved prescribing information includes a risk of ‘syncope,’ a consumer-directed ad should mention a risk of fainting, rather than using the medical term syncope.
“The major statement should also avoid the use of vague terms or explanations that are readily subject to different interpretations. For example, if a drug’s prescribing information indicates that more than half of patients taking the drug experienced a particular adverse event, the major statement should accurately convey the frequency of this risk (e.g., ‘‘more than half’’) rather than vaguely indicating that ‘‘some patients experienced’’ the particular adverse event.
