By: Joseph Famulare
Vice President, Global Quality Compliance and External Collaboration Genentech/Roche, Pharma Technical Operations
Vice Chair, ISPE Board

PillsWhen patients take their medicine, they trust it will be safe, effective and pure: that is the covenant that exists between patients, the pharmaceutical industry and regulatory bodies. What ISPE is doing through its Quality Metrics Pilot Program (QMPP) is collecting data to help the FDA make sure that covenant remains intact.

“ISPE is unique in having driven a data-based approach to effectively understand quality metrics.”

On 9 July 2012, President Obama signed FDASIA into law, reauthorizing user fee programs for innovator drugs and medical devices and establishing two new user fee programs for generic drugs and biosimilar biological products. The law also gave FDA new authority to better protect the drug supply chain, which is critical in an increasingly global marketplace. In addition, FDASIA provided the Agency with new authorities to combat drug shortages and stimulate antibacterial drug development…, included provisions intended to encourage drug innovation, made a number of important changes to medical device regulation, and added a number of other important provisions.

When Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), first introduced the concept of quality metrics in 2013, FDA was open in obtaining feedback how this best be done and provide the desired outcomes. ISPE, through its volunteers, has been responding and is now preparing to reveal the results and initial findings of a first wave of data collected across 44 sites and 18 companies. We are now ready to provide real-world experience with metrics definitions, data collection and reporting burden for the benefit of industry and regulators.

ISPE is in a unique position in that it uses data-driven approaches to understand and move forward on its strength of science technology, engineering, manufacturing and regulatory expertise of its membership.

The ISPE QMPP will bring in metrics—metrics that everyone in the pharmaceutical industry needs to come to understand—that can gauge quality at a particular site and the products therein. The results of our collective effort will change how the pharmaceutical industry will be regulated going forward.

FDASIA really got this ball rolling, by making it possible for the FDA to gain information prior to inspections. FDA as a regulator serves as the patient’s surrogate for quality. Properly applied and understood, quality metrics will enhance industry and FDA’s understanding.

As an industry, the thinking needs to expand from meeting compliance to prioritizing quality. Quality metrics will help quality differentiation for patients and payers alike. If we succeed, and

I believe we shall, the change will be transformational across our industry and within the FDA.

It is imperative to continually improve and innovate on the quality front in our manufacturing facilities.

But first, let’s meet in Baltimore, MD from 21 to 22 April, along with industry and FDA colleagues at the Quality Metrics Summit.

We’ll discuss the QMPP findings and respond based on your input, your concerns and your ideas. And then we’ll see how we want to tackle the second wave of QMPP.

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