Risk management means more than REMS strategies and tactics, or validated methodologies and therapeutic registries. What it’s really about is assuming the mantle of responsibility.
Social media for regulated industry is a green field of opportunity. But to maximize the opportunity, we must accommodate the reality of a messier world. Social media, is messy and the regulatory framework (or lack thereof) is equally so. Get used to it. Embracing social media means embracing regulatory ambiguity.
A reported FDA plan, secretly developed to enforce the rarely used 36-year-old “strict liability” Park Doctrine against Forest Laboratories CEO Howard Solomon, reflects a poorly performed balancing of interests–given that the agency always forgives itself for the transgressions of its own subordinates.
Even a cursory review of FDA’s April 28, 2011 Federal Register Notice, soliciting comments on several proposed consumer studies testing different ways of presenting benefit and risk information in online DTC prescription drug websites, reveals how far away FDA is from issuing guidance on key issues of concern to industry. A conspicuous example is the use of hyperlinks to provide risk information.
There’s a generational element to the failure of the Obama administration’s much-hyped agenda to increase transparency at government agencies like FDA, where reform has been submerged by bureaucratic resistance.