Category Archives: FDA

FDA social media guidelines: Access denied in most cases

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. Continue reading

FDA kind of gets it right-DTC Ads

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. Continue reading

Cutting fair-balance of drug TV ads

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? Continue reading

Key Highlights-FDA & Social Media Marketing

cgicompassThe following analysis was written by Justin Freid, Director Search Engine Marketing, CMI/Compas: The FDA has proclaimed it is acceptable to promote a product on company controlled forums and channels. It is also acceptable for a company to promote their products on third party sites such as Twitter and Facebook. Per the FDA‘s a firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm.’ Continue reading

FDA Draft guidelines: Real world examples

screenshot_1393By now M-L-R teams are reading the draft guidelines from the FDA for Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.  The most debated content of this document is going to be ” A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm .Continue reading