FDA Updates its Restructuring: No News but it’s Progressing
As promised, FDA Commissioner Robert Califf did provide an end-of-February update on the restructuring of the agency’s food safety program – although, coming less than a month after the promise of an FDA redo, one couldn’t expect bombshell revelations nor any concrete progress.
Following a year of pressure from every angle, Califf on Jan. 31 promised a major restructuring of the food side of the agency, to be called the Human Foods Program. “My search for a new Deputy Commissioner for Human Foods is underway,” Califf said up front. With a lot riding on that position, no one expected it to be filled quickly.
Seemingly answering recent public criticisms that the appointee will be no more powerful than the current deputy commissioners, Califf said:
“One key to success will be an empowered Deputy Commissioner for Human Foods who will report directly to the FDA Commissioner. The agency is focused on identifying a candidate that has the expertise to provide leadership over the FDA’s nutrition and food safety programs (including programs aimed at preventing and responding to chemical, microbial, and other hazards). The ideal candidate will have executive-level and real-world experience sufficient to lead the newly envisioned Human Foods Program and its vast remit. This individual will also have clear line of authority over the proposed Human Foods Program, which would include the existing components of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and certain human foods-related components of ORA” [Office of Regulatory Affairs].
“There have also been a number of questions about the proposed operational changes for ORA and how these plans will work with changes to the Human Foods Program. I cannot stress enough that my vision is focused on a new, agency-wide model where the activities and responsibilities of the regulatory programs and ORA are better synced to improve efficiency and effectiveness with clear decision rights so that everyone knows who has authority.”
The Feb. 28 release said FDA will create a new model that better integrates ORA’s enterprise-wide expertise in field-based operations with product subject matter experts who sit in all the agency’s programs.
Califf did note one immediate and specific change: Cosmetics regulation and color certification functions will be moved out of CFSAN and into the Office of the Chief Scientist.
“We’ve heard loud and clear that the current resource distribution and operational model between the FDA’s regulatory programs and field operations are siloed and there’s too much duplication,” Califf said. “We intend to fix this and strengthen both the regulatory programs and field force.”
In summary: There’s a lot of analysis and assessment going on behind the scenes. More updates will come as warranted. The FDA is seeking to finalize its proposal this fall.
