FDA Creates New “Super Office” in Effort to Improve Pharmaceutical Quality

The U.S. Food and Drug Administration (FDA) recently announced the creation of a new “super office” in an effort to improve quality control and effectiveness of pharmaceuticals. The Office of Pharmaceutical Quality, or OPQ, will open January 2015.

The new “super-office” will centralize the review, inspection, and research of drugs, especially generic drugs that do not undergo the same rigorous testing of brand-name drugs. The focus of the new office will be on safety, quality and the effectiveness of drugs.

Janet Woodcock, the Director of the Center for Drug Evaluation and Research (CDER) at the FDA, will head the new office. Ms. Woodcock explained that “[t]he organizational structure, along with new processes and policies, will support our mission to ensure that safe, effective, high-quality drugs are available for the American public.”

In our practice, we have seen devastating injuries and deaths from dangerous and defective drugs. We applaud the FDA decision to centralize all aspects of drug review, inspection, and research, and we hope that greater focus on drug development will improve drug quality and prevent dangerous and defective drugs from entering the marketplace.