Major Reorganisation at FDA will affect GMP Inspections

The US Food and Drug Administration has informed about a major reorganisation. The FDA has announced plans to introduce a new organisational structure which will become effective on January 2015. In the center of the reorganisation, the FDA will introduce the new Office of Pharmaceutical Quality (OPQ).

According to RAPS online OPQ "has gotten final approval to launch from FDA, along with an expected launch date—1 January 2015—and a slate of leaders for the new "super office." In an email to CDER employees on 16 October 2014, Woodcock said she would serve as the first acting director of OPQ, with support from Deputy Director Lawrence Yu, who replaced Webber as acting director of OPS in September 2013. Also joining OPQ will be a large slate of other leaders:

•Office of Program and Regulatory Operations (OPRO): Giuseppe Randazzo (Acting)
•Office of Policy for Pharmaceutical Quality (OPPQ): Ashley Boam (Acting)
•Office of Biotechnology Products (OBP): Director: Steve Kozlowski
•Office of New Drug Products (ONDP): Sarah Pope Miksinski (Acting)
•Office of Lifecycle Drug Products (OLDP): Susan Rosencrance (Acting)
•Office of Testing and Research (OTR): Lucinda (Cindy) Buhse (Acting)
•Office of Process and Facilities (OPF): Christine Moore (Acting)
•Office of Surveillance (OS): Theresa Mullin (Acting)"

The new organisation will have a major impact on all inspections performed by FDA. With this step, FDA wants to improve the efficiency of its enforcement activities. Other Sources: FDA Webpage

Just a few days earlier, Dr Margaret Hamburg, Commissioner of the US FDA announced the new Program Alignment. A task force of senior FDA officials 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." As a result, action plans have been published:

•Biological Products FY2015 Program Alignment Action Plan

•Pharmaceuticals FY 2015 Program Alignment Action Plan

Among the many different actions defined in the programme, the FDA states:

"CDER, CVM and ORA will collaborate to improve consistency and establish clear guidance about the use of regulatory tools, including advisory and enforcement actions, to increase efficiency, reduce duplication of efforts, and provide clear accountability. The establishment of a specialized Agency drug compliance officer cadre will contribute to this effort. Additionally, in FY2015, CDER, CVM and ORA will identify a strategy to clarify roles and responsibilities, including lead roles and decision rights, and streamline and delayer the business processes associated with the following compliance activities:
- Domestic and foreign Warning Letters;
-Judicial Enforcement Actions;
- Import Decisions;
- Compounding;
- FDASIA, and other administrative compliance tools;
- Clinical disqualifications; and
- Recalls"

Worldwide the different agencies need to react to the new challenges of a global pharmaceutical environment. Manufacturing operations have been moved to different parts of the world - especially to Asia. The quality level has never been so diverse. Counterfeit and fraud are an issue of concern. But also major GMP compliance deviations have alarmed regulators worldwide. A more comprehensive enforcement is urgently needed and product quality is now in the center of attention.

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