Request for Quality Metrics

Re: Docket FDA-2015-D-2537 for Submission of Quality Metrics Data; Comments of the Association for Accessible Medicines The Association for Accessible Medicines (AAM) formerly Generic Pharmaceutical Association (GPhA) is pleased to provide comments to the Food and Drug Administration (FDA or the Agency) on the Agency's revised Draft Guidance on the Submission of Quality Metrics Data (Draft Guidance) issued in November 2016. 81 Fed. Reg. 85226 (Nov. 25, 2016) (Docket No. FDA-2015-D-2537). AAM appreciates FDA's efforts to revise and re-issue the Draft Guidance to address industry's prior comments and concerns. We also appreciate FDA's agreement to extend the deadline for submitting comments to the revised Draft Guidance to permit AAM and others to thoroughly assess it and to share our thoughts on this important public health issue.

Comments from the Cross-Industry Quality Metrics Collaboration Group regarding Docket FDA-2015-D-2537: Submission of Quality Metrics Data. The undersigned trade and technical organizations, representing a broad, informal group, stand together on behalf of the vast majority of the U.S. pharmaceutical industry as the Cross Industry Quality Metrics Collaboration Group (the "Collaboration Group") to provide feedback on FDA's Revised Draft Guidance on Quality Metrics.

Re: OMB Control Numbers 0910-0139 and 0910-New; Submission of Quality Metrics Data; Docket No. FDA-2015-D-2537 The Association for Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association, is pleased to share its concerns with the Office of Management and Budget (OMB) regarding the above-captioned collection of information proposed by the Food and Drug Administration (FDA or the Agency). See 81 Fed. Reg. 85226 (Nov. 25, 2016). AAM represents the manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry. Our members manufacture more than 90% of all generic pharmaceuticals dispensed in the U.S., and their products are used in more than three billion prescriptions every year. Generics represent greater than 89% of all prescriptions dispensed in the U.S., but only 27% of expenditures on prescription drugs. AAM is the sole association representing America's generic pharmaceutical sector.