CDER to Expand Office of Generic Drugs

As a result of the passage of the Generic Drug User Fee Amendments Act (GDUFA), Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) stated, in a Sept. 7, 2012 memorandum to CDER staff, her plan to reorganize the Office of Generic Drugs (OGD) into a “super office” that would include subordinate offices. The new super Office would report directly to Director Woodcock, with Greg Geba, MD, continuing his role as OGD director.

Another related proposal is to creation of an Office of Pharmaceutical Quality (OPQ) that would oversee quality throughout a drug’s life cycle. This office would take on some of the functions of the Office of Pharmaceutical Science (OPS). Woodcock also proposes aligning some functions of the Office of Manufacturing and Product Quality (OMPQ) into the new OPQ. OMPQ enforcement and compliance functions with remain in the Office of Compliance.

“All of these changes would be part of our ongoing efforts to ensure that CDER’s organizational structure supports our mission to ensure safe, effective, and high-quality drugs for the public," Woodcock stated. "As a regulatory agency, we want the public to be confident that we are successfully dealing with the global economy that is constantly adding more players, more technologies, and more complexity. I believe these organizational changes would give us the foundation we need to meet these new and ever-changing challenges.”

Woodcock stated there would be additional structural changes to come that will “sharpen our focus and bolster our resources around pharmaceutical quality. Quality is the underpinning of everything we do, and it is imperative that we have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety.”