BPTF Warns FDA on Reduced API Manufacturer Inspections

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-06-04-2014, Volume 10, Issue 6

The Bulk Pharmaceuticals Task Force asks FDA to respond to concerns about reduction in API facility compliance inspections.

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates, issued a letter to FDA on May 27 asking that the agency ensure the frequency of inspections for any domestic API manufacturer remains consistent. 

The letter addresses the Department of Health and Human Services FY 2015 FDA budget justification disclosing that the FDA would be scaling back the number of domestic API inspections by nearly 40 percent in favor of elevating the number of foreign inspections. This action, BPTF says, could result in the failure of a number of compliant API manufacturers to receive safety inspections in a timely manner and not meet the agency's Generic Drug User Fee Amendments (GDUFA) commitment of inspecting domestic API manufacturers within a 3-year cycle. 

"We support the goal of inspection parity for both foreign and domestic API manufacturing facilities and ensuring that the FDA has the resources it needs to successfully conduct these inspections" said John DiLoreto, Executive Director of BPTF."We are simply asking the agency to ensure that, in conformance with its obligations expressed in the GDUFA Commitment Letter, the frequency of safety inspections is not compromised. The negotiated GDUFA inspection goal is to increase the frequency of foreign facility inspections, not to reduce the inspection frequency of domestic facilities"


Source: Society of Chemical Manufacturers and Affiliates