What Does a New FDA Quality Office Mean?

2014-bl-magnifying-fda-page-image (3)If the new quality office doesn’t mean new requirements, then what exactly does it mean?

The news that the FDA is creating a new Office of Pharmaceutical Quality probably set off the alarm bell for the industry. Does a new quality office mean new requirements? It’s the first question that comes to mind.

And FDA Commissioner Margaret A. Hamburg was very good about anticipating the question when she talked about the new office. “Let me emphasize that we’re not talking about new quality requirements,” she said at the annual conference of the Generic Pharmaceutical Association earlier this year. “Our current GMP regulations have been in place for decades; there have been no recent changes that would substantially impact requirements for product manufacturing.” (1)

That’s great news; now everybody can relax! The next logical question is: If the new quality office doesn’t mean new requirements, then what exactly does it mean? “We’re talking about complying with existing ones [regulations],” said Hamburg, who emphasized the importance of quality throughout her speech.

So enforcement— not new requirements— is what the new Office of Pharmaceutical Quality is all about. Its establishment signals the FDA’s renewed focus on quality and continuous quality improvement.

Quality is FDA Priority

“Year in and year out, we say much about safety and efficacy. But without product quality, none of us can feel confident that the product will be either safe or effective,” said Hamburg. “That’s why we’ve chosen to make quality one of our highest priorities this year and we’d like you to do the same.”

The FDA commissioner specifically noted the importance of maintaining “top-quality manufacturing controls and standards, and robust quality and risk-management systems” in all levels of operations.

“We must be strategic and have systems in place that are capable of continual quality surveillance. This will make it possible to detect issues early enough so that steps can be taken to prevent patient harm and avert shortages,” said Hamburg.

Based on Hamburg’s speech, here’s what we know so far about the Office of Pharmaceutical Quality: The Center for Drug Evaluation and Research is creating the new office, which will address the increasing complexity of pharmaceutical products. The new office’s goal is to “improve consistency and regulatory certainty across the wide span of drug quality review.” No timeline was given as to when the new office will begin its operations.

This FDA initiative should invigorate the pharmaceutical industry in promoting quality from within. It should encourage companies to renew their commitment to product safety and quality and to rally their employees and stakeholders behind the goal of continuous quality improvement.

It’s hard to argue with the FDA’s top dog when she said, “At the end of the day, the major responsibility is not on FDA but on industry.”

Cindy Fazzi, a copywriter at MasterControl Inc., writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University.

Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.


(1)  From a speech made by FDA Commissioner Margaret Hamburg on Feb. 22, 2013, viewed on July 3, 2013 at: http://www.fda.gov/NewsEvents/Speeches/ucm340870.htm