FDA Set To Launch Office Of Pharmaceutical Quality

The Regulatory Affairs Professional Society (RAPS) reports that the FDA is finally ready to launch the Office of Pharmaceutical Quality (OPQ), a new branch of the FDA that will focus exclusively on drug quality both before and after the drug has been released onto the U.S. market.

The new program involves an agency restructuring with many existing offices turning over some of their quality-related responsibilities to OPQ. The Office of Pharmaceutical Science (OPS), Office of Generic Drugs (OGD), the Office of Manufacturing and Product Quality (OMPQ), and the Office of Compliance will all lighten their workloads and turn over functions to the OPQ.

According to the FDA, it is the agency’s current practice to address quality in a fragmented manner. One program monitors the drug in its development and another oversees quality control after the drug is launched. Ideally, the OPQ will monitor a drug throughout its entire lifecycle from application to post-market.

This new office is the brainchild of Janet Woodcock, the director of the Center for Drug Evaluation and Research, who proposed the OPQ in 2012.

RAPS quotes Woodcock’s explanation of the FDA’s need for an OPQ. She states, “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.”

The formation of this program is part of an ongoing initiative by the FDA to address drug shortages in the U.S. market. The FDA cites the primary reason for shortages as issues with quality and manufacturing.

According to Woodcock, an ongoing trend of sourcing raw materials outside the U.S. makes the OPQ all the more imperative. She explains, “We must be strategic and have systems in place to identify and respond to quality issues before they become problems.”

The goal of the OPQ is to foster a “maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.”

RAPS blames the delay of OPQ’s launch on the resignations of a few key leaders and ongoing discussions about the agency’s restructuring, however despite the setbacks, reports that the new program is ready to move forward in January of 2015.