Warning About Warnings!

As I mentioned in an earlier posting on February 24, the FDA has dramatically increased the issuance of MedWatch Alerts.  Now the Baltimore Sun reports on the issue, which touches upon another matter discussed here – the relevance of FDA risk interventions in the current environment.

At that time, I was talking about Black Box Warnings, and whether or not they actually make a difference in the way physicians prescribe drugs.  Included in that is whether or not prescribers even are aware of the fact that drugs they are prescribing even have Black Box Warnings.  The lack of data about this is a little disturbing given the FDA’s reliance on this risk management mechanism.

Likewise for the MedWatch Alerts.  It would appear that, rather than rely on FDA communications, many physicians are turning to private sources to get their information about drugs.  J0341706

Is the FDA issuing so many warnings that, rather than becoming more relevant it is becoming less relevant?  The Baltimore Sun article states that the FDA worries about physicians getting their information from the private sector out of concern that private commercial interests could influence the information when they should be more worried about the fact that tax dollars are being spent on a system that isn’t working as well as the private sector. 

One way to get the upper hand is to invest some time and resources into studying physician attitudes, beliefs and understandings on the relevance of these risk management tools.  The agency requires companies that manufacturer medical interventions to provide a great deal of data on efficacy and safety before approving a drug.  Likewise, the agency should turn that standard inward and require a reassuring level of study on the tools it uses to communicate risk.   

Recently the agency hired Booz Allen to "assess post-marketing study commitment decision-making process" (I did not make up that tortured phrase, this it nearly the entire headline of the press release).  That is an example of using money to evaluate functionality.  But the heavy reliance on Black Box Warnings and MedWatch alerts cries out for study.  Without that kind of data, while trying to demonstrate that the FDA is doing a better job of protecting public health by issuing more MedWatch Alerts, the agency may just be shooting itself in the foot by engaging in an effort that is of diminishing relevance to the practicing physician. 

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
This entry was posted in FDA Policy, Regulatory Communications, Risk Management. Bookmark the permalink.

Comments are closed.