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Sep 15, 2016

Is Compliance an Obstacle to Quality?

The FDA is shifting from a primary focus on 
regulatory compliance to driving the industry 
beyond compliance by focusing on product quality.


by Daniel Matlis

Founder and President, Axendia


Editor’s Note:  Recent news about FDA’s Quality Metrics initiative triggered an “I told you so” moment: Is Compliance an Obstacle to Quality? Axendia wrote this article over two years ago in Life-Science Panorama (http://axendia.com/blog/2014/04/14/is-compliance-an-obstacle-to-quality/ ).  It’s as true today as it was then.

Can you distribute poor quality products while complying with regulatory requirements?  Sure, after all, you can conduct a recall of poor quality products in compliance with all applicable regulations.

Regulatory compliance and quality are NOT the same.  In fact, the industry’s hyper-focus on compliance is often an obstacle to quality.


This distinction seems to be the renewed focus at the FDA, from the Commissioner on down…


“In recent years the FDA has identified significant lapses in quality by some companies operating in the U.S. and around the world…”

“…we at the FDA will also continue to increase our focus on quality. One way we are doing this is through the creation of a new Office of Pharmaceutical Quality that will create one voice for drug quality at the FDA and improve our oversight of quality throughout the lifecycle of a pharmaceutical product.”

“All companies must understand that quality is the basis for the public’s trust and confidence in their products and maintaining high quality standards is part of the cost of doing business.”

FDA is changing its stance on manufacturing. It’s shifting from a primary focus on regulatory compliance to driving the industry beyond compliance by focusing on product quality.

Howard Sklamberg, J.D., Director, Office of Compliance at the FDA’s Center for Drug Evaluation and Research, was instrumental in establishing the FDA’s new Office of Pharmaceutical Quality.




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In recent remarks, Mr. Sklamberg stated:

“We don’t have the capacity to all the time to be in every firm.  But we want to encourage those firms to prioritize quality and encourage their boardrooms and their pocketbooks because quality cost money.

“We want to target our limited inspection resources to the firms that we think are ones that pose the greatest quality risk.”

The Agency’s push toward improved manufacturing quality is evident in the FDA’s “Case for Quality Initiative.” Through this initiative, the Agency is working to implement policies which drive industry to go beyond compliance with regulations and provide an enhanced focus on manufacturing quality.

According to Steve Silverman, director of the Office of Compliance at the FDA’s Center for Devices and Radiological Health:

“If we are able to work with manufacturers to create a shared understanding of what quality design and production practices look like, manufacturers who want to lead the industry in terms of the quality of their products are able to do so.”

”That means that we are able to direct resources away from those manufacturers in whom we have confidence to other manufacturers for whom we may have less confidence or more limited information. We are able to use our resources more strategically to accomplish broader, but also more effective surveillance.”

The Case for Quality Initiative is based on an analysis of data that clearly shows firms that managed risks by driving quality across the organization tend to be more productive, with fewer complaints and investigations per batch.  In addition, these firms often have smaller quality units with lower quality-related costs than their competitors.

In today’s complex manufacturing processes, life science executives must balance a multitude of divergent interests and concerns.  At the end of the day, the safety, quality, efficacy and/or effectiveness of each product must take overriding precedent.

The question life science executives should ponder is:  How can we improve manufacturing and product quality to ensure that our company does NOT have to execute regulatory compliant field actions?

It is my firm conviction that regulatory compliance must be the by-product of well-designed and executed processes aimed at producing the highest quality product, not their drivers!

Ellyn McMullin contributed to this article.

Do you agree that regulatory compliance and quality are not the same? Share your comments below.


Daniel R. Matlis is Founder and President of Axendia, An analyst firm providing trusted advice to Life-Science and Healthcare Executives on Business, Technology and Regulatory matters.

Dan has over 25 years of experience in the Industry spanning the entire value chain.
He is an active member in FDA’s Case for Quality Initiative and has presented Axendia’s research findings to industry executives and the FDA.

Dan began his career at Johnson & Johnson (Ethicon), where he provided leadership in the areas of technology, regulatory compliance and business. Before founding Axendia, Dan was a Partner, VP and General Manager at a leading Life-Science consultancy firm.

He is a frequent lecturer at Industry events and has published numerous research reports and articles on key issues facing the Life-Sciences and Healthcare industries. 


Dan holds a BS in Electrical Engineering from Polytechnic University (now NYU Polytechnic School of Engineering) in NY and a MS in Management from the New Jersey Institute of Technology.





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