accessdenied-375x250POST SUMMARY: The question of how pharma companies can meet fair balance requirements in character-limited formats has been a major barrier to the use of social media. The FDA is saying that the channel isn’t suited to complex and high-risk products.  This guidance is a clear indication that the FDA does not understand how consumers are making healthcare decisions and it will prohibit a lot of pharma companies from really leveraging social media to help patients find relevant information online.

fda almost rightAccording to the Pink Sheet: The long litany of a prescription drug’s risks in direct-to-consumer television ads could become a thing of the past. FDA plans to conduct a study to determine the impact of limiting risks presented in the ads to those that are serious and actionable while also stating that there are other risks not disclosed in the ad.   After viewing the ad, participants will respond to questions about information in the ad to assess their understanding of product risks and benefits; the disclosure about additional risks; product quality; their intention to seek more information about the product; and their perceptions of trust/skepticism regarding product claims and the sponsor.

idonthetitThe Los Angeles Times  says that the FDA is studying whether limiting TV drug ad disclosure only to serious side effects would improve consumer understanding.  “Our hypothesis is that, relative to inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks,” the FDA said. Ha?