The FDA’s Quality Revolution

September 18, 2015 YourEncore Marketing




Last week in this space I recounted the top 10 regulatory issues that keep my mind churning at night. One of these is the FDA’s new Super Office of Pharmaceutical Quality (OPQ), which Center for Drug Evaluation and Research (CDER) Director Dr. Janet Woodcock calls a “regulatory revolution.”

To understand this revolution, let me put OPQ into some historical context and share some key comments from Dr. Woodcock herself from a webinar I moderated for FDA News in July.

In 2009, the FDA announced it's Safe Use of Drugs Initiative. The theory being that one way to make drugs safer is to ensure that they are used as directed. The main strategy is educating physicians, nurses, pharmacists and patients.

The Super Office of Pharmaceutical Quality, announced earlier this year, adds another dimension to the effort: developing a risk-based approach that includes data gathered from a variety of sources, including manufacturing inspections, adverse event reporting, and substandard pharmaceutical events. The idea is that there is no such thing as a safe substandard product.

As Aristotle said, “Quality is not an act, it is a habit.” Dr. Woodcock intends to make pharmaceutical quality a habit.

“We think industry should own quality. And to own quality you need to measure it, because you can’t improve anything that you haven’t measured,”she said. “We would really like to see companies have quality dashboards to understand for themselves the state of quality in their facilities, and also have companies submit quality metrics to us to facilitate the uptake of this attitude within the industry.”

After working with the industry on these metrics over the course of a number of years, Dr. Woodcock anticipates being able to incorporate them into the OPQ risk model and to determine the overall quality of drugs marketed in the United States. This will lead to better insight into where to spend limited resources. The same is true on the postmarket side, in being able to know the quality of U.S. drug manufacturing.

“We have long wondered and not known fully when and whether quality problems lead to adverse events,” said Dr. Woodcock. “Now we’re forming a very good relationship with Office of Safety and Epidemiology (OSE) and I think we’ve already worked on and identified various quality problems that actually can or have perhaps led to either complaints or problems that are reported to OSE. There’s a very bright future for a seamless safety net that includes quality problems as well as inherent properties of the drug.”

So how does this “revolution” impact the industry and how will it change behavior?  I can offer four key points:   

  1. Quality isn’t only about cGMPs anymore. Manufacturing is where the conversation starts – not ends. It’s the beginning of the quality loop.
  2. Procurement can no longer be about finding “the cheapest” API and excipients. Adverse events and substandard pharmaceutical events will be investigated with ingredients being front and center.
  3. Safety and surveillance will no longer be a stand-alone function, but rather the base of the “risk-based” pyramid.
  4. Much closer coordination between “quality” functions can’t just be an FDA issue. Industry (both innovator and generic) must form internal task forces to change their own quality policies, processes – and philosophy.

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Authored By: Peter J. Pitts is an authority on global regulatory issues and an Executive Partner at YourEncore. He is a former FDA Associate Commissioner, the Chief Regulatory Officer for Adherent Health Strategies, and the President of the Center for Medicine in the Public Interest, a policy institute he founded in 2004.For more on my interview with Dr. Woodcock, please visit You can also download the webinar.

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