The QMN Weekly Bulletin

FDA Adds Quality Metrics, Drug-Device Generics to 2016 Guidance Lineup

Oct. 14, 2016

The FDA will revise its recommendations for the submission of quality metrics and provide advice on comparative analyses for drug-device generics before the year ends.

An updated agenda indicates that the FDA will release an amended version of its guidance on quality metrics, which received significant industry pushback because of the burden those requirements, could impose on drug manufacturers.

In the initial draft guidance, the FDA identified 10 metric points that manufacturers will need to collect for the computation of four quality metrics for each of their products.

PhRMA pointed out that while many manufacturers collect these metrics, their methods vary and exclude certain out-of-specification data. To gather all the metrics listed in the guidance, a manufacturer would have to spend about 25 hours, the International Society for Pharmaceutical Engineering estimates.

The FDA has reassured industry that it will not issue 483s, warning letters or other enforcement actions over the collection of these metrics.

After considering the stakeholder input, the FDA decided to revamp the draft document “to outline a revised program that incorporates many of the substantive stakeholder comments,” an FDA spokesman said.

The second guidance added to the FDA’s agenda is intended to shed light on how generics makers can conduct comparative analyses for the device component of a combination product.

The agency’s announcement of the guidance follows increased concern over the FDA’s review of generics for Mylan’s EpiPen, which in less than a decade rose in price by about 400 percent.

Specifically, Reps. Fred Upton (R-Mich.), Joseph Pitts (R-Pa.) and Tim Murphy (R-Pa.) asked the FDA how ANDAs for combination products are reviewed and how many ANDAs has the agency received and rejected for generics of the EpiPen.

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