The FDA is scheduled to announce today a Risk Management Workshop designed to discuss such programs and share information among key stekholders.
Risk Management has been an increasing source of concentration in the post-COX-2 era. There were compounds prior to the COX-2’s that indicated risk management was perhaps a science that is not yet quite a science – note the Rezulin withdrawal.
As noted in yesterday’s posting, the risk/benefit equation is increasingly murky. There is no specific formula to point to that defines it, though a commenter on yesterday’s post posed an interesting calculation, for which I’m thankful. But the truth is that, for all the concern for safety, little has gone into defining the efficacy of the risk management interventions that are successful in the same scientific manner that risk and benefit are assessed.
In other words, while they may exist, I’m not aware of any studies that tell us the impact that a Black Box Warning from the FDA has on prescribing patterns or considerations on the part of a prescriber for risk. I welcome comment citing such studies. There are many other risk management interventions – MedGuides, stickers on the outside of pharmaceutical containers, patient contracts and the like. But how do these impact prescriber and patient attitudes and beliefs?
According to the FDA notice to be published today, this "public workshop is intended to seek constructive input from a wide range of stakeholders…to help in the development and implementation of mechanisms to minimize the risks of pharmaceuticals with unusual safety and patient monitoring concerns."
What is lacking is a method to evaluate their effectiveness. It is time to hold a workshop not just on methods, but how well they work. To my knowledge, PDUFA IV does not have funding for such evaluation – and I could be wrong – but if it doesn’t, it should. Hopefully, this workshop will include a component of risk management evaluation as well.