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Sunday, June 21, 2009

Insight from and FDA Staffer


This message is going out to clients & friends of Bioscience Translation & Application.  A few days ago I sent the following tweet on Twitter:

Interesting talk w FDA staff-Lots of new inspectors & General Counsel is signing off on warnings & actions much faster-expect more activity!

I’ll flesh it out for you.  In an informal conversation with a current FDA staff member I learned that the agency is expecting to issue many more warning letters and to follow up on those warnings much more quickly.  Why is this?  First, last fall the agency hired hundreds of new inspectors.  This was in response to the many issues that had come up previously—adulterated heparin and food ingredients to name only two. 

The second and probably most important reason we should expect to see much more enforcement activity from FDA is that with the change in administration, the Health and Human Services Office of General Counsel, which must approve every warning letter and other action, is processing these actions at lightening speed. In the past, warning letters could wait six months or more for approval.  However, a warning letter that went out in early June 2009 was the result of an inspection that took place in mid-May 2009. 

The person I spoke with was delighted with these changes and hopeful that FDA will be able to readily fulfill its mandate to protect public health, particularly since the agency is expecting a 30 to 50% increase in their operating budget.

Since no one is perfect, what does this mean for you and your company?  Do you need to tighten up your GMP processes—perhaps review SOPs?  Is it time to review your marketing programs and labeling?  Contact us if you think you need to do anything other than relax and enjoy summer!

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