ISPE presented viewpoints and recommendations (see slides) on the U.S. FDA’s draft Request for Quality Metrics Guidance for Industry at a public meeting held at the FDA’s White Oak Campus in Silver Spring, MD.

“The FDA Public Meeting marked an important milestone as FDA and industry continue on the Quality Metrics journey,” noted Diane Hagerty, Vice President, Genentech, Inc., and one of the ISPE Quality Metrics Team leaders.  Public comments and support for continuing the advancement of the Quality Metrics initiative were shared by all of the major industry trade associations (ISPE, CHPA, PDA, PhRMA, GPhA, IPEC and BPTF).  At the same time, common themes emerged regarding recommendations to be incorporated and additional concerns that still need to be addressed.  Ms. Hagerty added, “On behalf of the many people and companies that have been contributing to the Quality Metrics efforts, it was gratifying to see ISPE’s work positively acknowledged throughout the discussions in the FDA Public Meeting.  This underscores the value of continuing our efforts to provide objective data and experience to inform ongoing dialogue.”

Among suggestions, we proposed a phased introduction to the guidance— for instance, starting with higher-risk facilities or products, or starting with voluntary reporting during the initial learning period. We also requested more transparency from the FDA on how quality metrics data will be used, along with refined FDA definitions.

Additionally, we recommended the FDA consider revising the structure of the proposed metrics reporting templates in order to better reflect how industry is currently gathering data and to thereby potentially decrease the reporting burden on companies.   In the public meeting we also commented, based on experience gathered from the Quality Metrics Pilot Program– Wave 1  that the reporting burden projections included in the Federal Register Notice accompanying the Draft Guidance appear to be significantly underestimated.

We support the FDA’s effort to implement a Quality Metrics program in collaboration with the industry and back the need for the program to start with a small, targeted approach that will enable the industry and FDA to learn and advance the approach over time.

Our comments represent input from our members and the knowledge gained from Wave 1 of the ISPE Quality Metrics Pilot Program; which mirrored many of the proposed metrics presented in the new FDA draft guidance.

Learn how your company can participate in our Wave 2 Quality Metrics Initiative.

ISPE’s public presentation and other participating organizations’ comments can now be found on the FDA website, along with recordings of the meeting and other meeting information.

Thank you to everyone who submitted your comments.

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