Life Science Compliance Update

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June 09, 2017

FDA Office of Regulatory Affairs to Undergo Realignment

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In a March hearing before the House Energy & Commerce Committee, FDA’s Jeffery Shuren announced the FDA’s Office of Regulatory Affairs (ORA), would undergo a program realignment. As the FDA notes, on September 6, 2013, then Commissioner Margaret Hamburg, M.D., created a Program Alignment Group (PAG) comprised of senior FDA officials. The PAG was charged with identifying and developing plans to modify FDA’s functions, processes, and structure in order to meet the challenges posed by scientific innovation, globalization, the increasing breadth and complexity of the products that we regulate, and new legal authorities.

May 2017 Realignment

Regulatory Focus received direct comment from FDA on the imminent changes. As they wrote, the long-planned program alignment for ORA will kick off in May 2017, saying the office "will be moving away from a geographic (regional) management model and align with a commodity-based program structure. All regional food and drug directors (RFDDs), regional directors and regional staff will transition into other positions in ORA."

As of May 17, Meyer says that FDA will sunset its five regional offices, replacing them with six commodity-focused divisions for drugs, biologics, medical devices, bioresearch monitoring, food and tobacco. Meyer also told Focus that the agency will maintain its 20 existing districts, with district directors gaining program specific responsibilities. Meyer also noted that the agency would not be closing any offices, and no employees will lose their jobs or be asked to move as a result of realignment.

How does ORA's new model affect FDA stakeholders?

As described the FDA, for a given product type the entire reporting chain for ORA’s inspection and compliance staff will specialize in that particular commodity. This is a significant change from ORA’s existing geographic-based model, where employees, regardless of their area of expertise, may do work in more than one program area. Ultimately these changes will result in a high level of technical expertise and more uniform application of ORA’s policies and processes. 

The agency states it wishes to keep pace with the acceleration of scientific innovation, global expansion of markets, and modern legal authorities, such as the FDA Safety and Innovation Act of 2012, the Drug Quality and Security Act of 2013, and the 21st Century Cures Act of 2016.

In addition to the FDA’s comments, the FDA Law Blog made several important points about this realignment back in 2016. Three specific quotes of interest:

“In other words, if you are spending two-thirds of your time as an investigator inspecting run-of-the-mill food, feed or tobacco facilities, does it really make sense for that same person to also be conducting inspections of recombinant biotech drug firms? The answer seems self-evident, until you realize that little in a huge bureaucracy is self-evident, and even less is readily achievable even when it is self-evident.”

“So, what to make of these objectives? From an industry perspective, having specialists, rather than generalists, analyzing a firm’s key systems seems like a no-brainer in terms of the specialist being better able to understand the complexities of the businesses being inspected and developing a better understanding of the inspected firm’s concerns. However, that alone does not mean that the quality of future inspections will be satisfactory.”

“One thing is certain. Firms that have thus far counted on investigators not discovering fundamental problems with their key systems are less likely to succeed after the PAG plan’s implementation, owing to the greater level of knowledge and specialization of investigators.”

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