Regulatory Hopes for 2012

DTC Perspectives Magazine’s Industry Forum asked some key thought leaders, including Heartbeat’s Bill Drummy, about the FDA’s Office of Prescription Drug Promotion (OPDP) and what they’d like to see come about in 2012:

“I would like to see from FDA’s OPDP for DTC in 2012 an honest admission that the current standard operating procedure for reviewing promotional pieces in the digital age is broken and needs to be fundamentally re-invented. Whatever its name, the office overseeing pharma promotional materials has failed in its mission to protect and advance public health because they have not enabled and indeed encouraged pharma to play a fulsome and responsible role in social media and other digital outlets.

I will be more specific: in November 2009, the FDA held hearings about the internet and social media, and heard testimony from some 80 different experts (including myself) about what it should do. Fast forward (as if) to today, and FDA still has not released any significant guidance
for the industry, except a single, not particularly helpful, announcement regarding what to do with off-label questions. In that same two-and-a-half years, apple will have released three versions of its transformative iPad product. It is as if the FDA lives in a totally separate universe (bizarro
world), where the technology revolution doesn’t seem to have arrived.”

Check out the full thrashing of the FDA on dtcperspectives.com:

“Regulatory Hopes for 2012″

Source: Bill Drummy, as featured in DTC Perspectives Magazine
Date Published: May, 2012