More on Enforcement from FDA and Shades of More to Come?

As noted in an earlier posting, FDA gave notice on Thursday that the agency was laying out a new vision for enforcement activities.  The effort attracted a good bit of media and the FDA even provided a video on the topic.  

The following day, however, the FDA also issued a release that outlined its new process for debarmentFDA Enhances Speed and Transparency of Actions Taken Against Misconduct in Drug and Device Development.  In its release, the FDA stated that the action was being taken in response to concerns raised by the House Committee on Energy and Commerce, Subcommittee on Health.   If the FDA is trying to please that committee, then there is going to be a great deal of change at the FDA – and these releases aside, there have been some big changes happening.

Last month, for example, Dr. David Acheson, Associate Commissioner for Food Safety, departed the FDA after a long tenure.  He presided over food safety at a time when the agency saw some of its most important challenges of late, including the tomato salmonella outbreak of 2008 and the entire malamine contamination issue.  During hearings on the Hill he was often given a very rough time.

Then yesterday, announcements appeared in the media that Daniel Schultz, the head of the Center for Devices and Radiological Health and like Acheson – a long time FDA employee, would be leaving the agency.  For some time, the regulation of devices has been a matter of scrutiny.  
 
These actions and changes in personnel are clear signals of change and are evidence of the determination of the new leadership to begin to restore public confidence in an agency that supports public health. 
 
Which is key to understanding how to communicate with the FDA in the future.  Industry is accustomed to appealing to FDA with data about safety and efficacy, but clearly to gain the attention of the new leadership, the discussion about new products and regulatory developments needs to take on a new dimension – public health.  Because it is less a particular medical discipline that is part of the leadership's character, it is a common vision of public health. 
 
Therefore, in the future, speaking to that outlook is going to be key to achieve greater success in communicating with the agency and in strategically assessing the directions the agency will take with respect to particular and evolving situations. 
 
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