Is the FDA Rearranging?

On Friday, September 6, 2013, FDA Commissioner Margaret Hamburg, M.D., announced in an internal email that she was forming a “Program Alignment Group” charged with identifying and developing plans to modify FDA’s functions, processes, and possibly its structure in order to best achieve mission-critical Agency objectives.”

“Significant strides in scientific innovation and increased biomedical discovery, the globalization of the food system and medical supply chains, as well as the expansion in FDA’s regulatory authorities via many new forms of legislation, require the Agency to continue to find ways to ensure that we are meeting our critical public health and regulatory mission, ” she wrote.

The Commissioner is asking senior leaders to report back in three months on their ideas.

Scott Gottlieb, a contributor for Forbes wrote on September 8, 2013 that there will be a lot of internal resistance. “A major re-organization will create a lot of dislocation. Big bureaucracies don’t respond well to this sort of dramatic change.”

He wrote that the best proxy was the unexpected merger of FDA’s drug and biologics center in 2002. By 2004, he continued, that re-organization was largely rolled back after internal resistance to the change mounted.

Gottlieb speculated that the most likely result of the effort will “result in FDA creating a few model programs that cut across its existing centers—and some mandates for better alignment. The focus is likely to fall on FDA’s post-market regime and its inspection resources, which right now reside across the different centers. I’d expect those to be better integrated after any reorganization.”

According to Hamburg’s memo, the group will look at “what changes may be necessary from an operational standpoint to transform the Agency from a domestic Agency operating in a globalized world to a truly global Agency fully prepared for a regulatory environment in which product safety and quality know no borders.”

“We need to transition to distinct commodity-based and vertically-integrated regulatory programs with well-defined leads, coherent policy and strategy development, well-designed and coordinated implementation, and a de-layered management structure, ” stated the memo.