DTC Loses Powerful Friends, Will PhRMA Bring Them Back?
This article was originally published in RPM Report
Executive Summary
Direct-to-consumer advertising is being blamed in large part for the pharmaceutical industry's eroding reputation. Some of the industry's oldest friends in Congress are proposing moratoriums on DTC ads. PhRMA's DTC guidelines may have mollified Congress and FDA for now. However, with the hundreds of billions of dollars lined up for the Medicare drug benefit, CMS could be the newest player in restricting DTC.
You may also be interested in...
DTC Public Health Slant: A Winning Formula With FDA Commissioner Hamburg
FDA Commissioner Margaret Hamburg is not taking the easy way out when she discusses DTC, even in front of Congressional critics of the practice. She does not treat DTC as primarily a regulatory problem for the agency; instead she likes to focus on the public health potential of DTC.
"Neutral" Is "Unbiased" In FDA' s Lexicon: Taking the Buzz and Distractions Out of Risk Statements
FDA is interpreting the new "neutral' standard for direct-to-consumer ads to mean "unbiased." Experts in FDA ad regulation policy are now debating what an advertiser has to do to be unbiased: does it just mean keeping down distractions during the statement of risk information? Or does it mean making an effort not to over-warn?
DTC Implications: FDA Calls Foul on Magic Johnson Promotional DVD
FDA's criticisms of promotional DVD for Abbott's Kaletra highlight pitfalls of celebrity testimonials. FDA says too much of the session with the basketball star focuses on benefits from the drug; risk information is just an afterthought. The interview with the net star also demonstrates FDA concept of inaccurate "net impression." The DVD creates implied claim that drug works for five years - without supporting data.