Lessons for a New Regulatory Era, Part 2

J0387276 Risk management is an iterative process, as the FDA likes to say. There are a broad spectrum of activities that comprise efforts at managing risk. There is the product labeling and within that there is the Black Box Warning (see posting of February 21). There are Medication Guides, which are printouts of information which are attached with every prescription. There are little stickers on the bottles warning you of drowsiness, not to drive, not to drink, not to take while nursing. There are Dear Doctor and Dear Healthcare professional letters. Risk management is not the event of instituting a precaution, it is an event which must be evaluated.

I was a speaker at the NIH conference on risk management for thalidomide in 1997. I spoke about patient and provider rights and responsibilities. There we talked about the more serious stuff – the use of birth control methods, the restriction on prescribers, prescriber education programs, prescriptions that are only good for one course of dosing, physician/patient contracts.

But to what extent can one manage risk with a population that is so diverse – geographically, culturally, linguistically? How can one maximize the management of risk with people who have poor reading levels or who suffer behavioral problems that compromise their ability to comply? Do we know what the most effective interventions are that achieve the best outcomes. We don’t. It requires study.

The time is approaching when industry is going to be held to greater scrutiny on its ability to manage risk, in today’s environment. All players will need to characterize what they are doing in risk management and how well they are doing it.

Nature hates a vacuum. This is an opportunity for members of industry to move forward and begin engaging in high profile studies to determine the extent to which various risk management interventions are effective and what interventions best reach which audiences. It is an opportunity to define the environment in risk management.

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