FDA Reforms are Underway As New Commissioner Takes Over Leadership.


In a recent interview, FDA’s Deputy Commissioner Lester M. Crawford addressed the many reforms occurring at the Agency.


One of the new initiatives in progress deals with a risk-based approach to inspections and approvals which Crawford explains is what the FDA is actually about.  “We need to inform the public that although there will always be risk, some things are riskier than others.”  Crawford also stated that his title could appropriately be “deputy risk manager”, because that accurately depicts the agency’s role.


Many of the changes or at least the acceleration of change, is due to the Bioterrorism threat.  Much of the bioterrorism legislation was directed at increasing the funds to the FDA to allow for their increased role.  Crawford gave Secretary Thompson credit for backing the legislation and defining the role of the agency.  Field Operations and Operators are directly affected by the changing of their roles.  Under the old system Crawford explained that field operators spend as much time monitoring table salt as they did cyanide.  The reality of cuts in personnel and funds makes monitoring the riskier products more important to the public’s safety.


As the newly appointed Commissioner, Mark McClellan comes into the Agency many changes are already underway.  At his hearing before Congress McClellan gave brief answers to the questions asked of him, promising more detailed answers once he takes on the position. McClellan comes to the FDA from CMS and he made it clear he feels the two agencies do not serve the same function, however,  he did state that the FDA and CMS (Centers for Medicare and Medicaid Services) could “collaborate more in safety surveillance of pharma products.”


McClellan also said, “I believe in credible, risk-based enforcement;” stating that he will be examining some of the criticisms against the agency closely.  He made it clear that he supports Research and Development and the expedition of the approval process.  In conjunction with that he said that he would support the using of 3rd parties to “supplement the agency’s Medical Device GMP inspections.”  He would like to build on the new program that facilitates the review of Combination Products through the Office of the Ombudsman.  When questioned about issues surrounding bioterrorism threats, McClellan came out at the hearing before congress as committed to working with manufacturers to prevent shortages of needed vaccines, without compromising on safety standards. 

The unwillingness to compromise standards was also mentioned when he was questioned about importing pharmaceuticals from other countries.  McClellan stated that he felt there was a risk involved to the public with such imports and he would not be willing to compromise the standards for the sake of importing them.  His first concern in all issues is that all needs are met safely and that the agency continues to act in the public’s best interest.