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Bulk Pharmaceuticals Task Force Alarmed at Reduction in Compliance Inspections

SOCMA affiliate sends letter requesting response from FDA

FOR IMMEDIATE RELEASE

Contact:
Jenny Gaines
Manager, Public Relations and Media
(202) 721-4123
gainesj@socma.com

Washington, D.C. – The Bulk Pharmaceuticals Task Force (BPTF), which is an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), issued a letter on Tuesday to the Food and Drug Administration (FDA) asking that the agency ensure the frequency of inspections for any domestic Active Pharmaceutical Ingredient (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 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. 

A copy of the letter is available here.

“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. ”

The BPTF is actively engaged in promoting and advocating for drug safety by increasing the number of FDA inspectors and foreign inspections through the implementation of an inspections fee schedule for generic drug and drug ingredient importers as needed to offset the costs to conduct such inspections. 

Additional information on the BPTF and its advocacy initiatives can be found here.

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The Bulk Pharmaceuticals Task Force is an association within the Society of Chemical Manufacturers and Affiliates (SOCMA)) that represents the interests of the manufacturers of active pharmaceutical ingredients, excipients and intermediates.  

The Society of Chemical Manufacturers and Affiliates (SOCMA) is the leading trade association of the specialty batch and custom manufacturing chemical industry in the United States.  Founded in 1921, SOCMA represents approximately 220 member companies worldwide.

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