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Article / Nov 26, 2015

FDA Draft Guidance for Industry: Request for Quality Metrics – FDA-2015-D-2537

ɫAV's comments on the draft - FDA - Request for Quality Metrics, 26 November 2015

Dear Sirs,

ɫAV thanks the FDA for the opportunity to present comments and suggestions on the draft guidance for industry “Request for Quality Metrics”.

ɫAV has been in business for 56 years supplying services as a CDMO to Innovators, and APIs to the generics industry to enable it to offer high quality affordable medicines. Our first FDA inspection was in 1982. We employ 1345 employees and supply to 50 countries. In each of the last 5 years we were the manufacturer behind 1 to 3 NDA approvals per year, in addition to being the referenced DMF holder for multiple ANDA approvals.

I have been CEO of ɫAV for almost 20 years. For about 40 years I have been fortunate to have had a front row seat at watching the global pharmaceutical industry evolve. My first words on this guidance are of amazement and congratulations to FDA for giving a role to “quality culture” [109] in its compliance requirements. The USA is fortunate to have the World’s gold standard regulator, the one that pushes innovation and is continuously raising the bar. Quality Metrics is another feather in its cap.

The Quality Metrics guidance amounts to a major innovation in FDA practice as it allows it to focus on quality and good performers rather than just on non-compliance and poor performers. We are very much used to an FDA that excels at using the stick, this guidance announces that FDA will learn to use the carrot. This is good because patients want capsules full of quality, not capsules full of compliance.

ɫAV is in full support of the proposed guidance in terms of concept and its proposed mechanics. Implementing the proposed Quality Metrics will entail considerable work for tens of thousands of people but that is very little compared to the benefit to the patient, to the quality and reliable supply of medicines in the US and elsewhere. If you do not measure you cannot manage, having mandatory quality metrics should set the industry on a journey towards better quality medicines. We also hope it will also provide patients, clients, prescribers and payors with an objective measure of quality that enables them to differentiate between manufacturers of both APIs and FDFs.

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