US Bulk Pharmaceuticals Task Force alarmed at reduction in compliance inspections

GDUFA inspection goal is to increase frequency of foreign facility inspections, not to reduce inspection frequency of domestic facilities

The Bulk Pharmaceuticals Task Force (BPTF), which is an affiliate of the US Society of Chemical Manufacturers and Affiliates (SOCMA), is seeking justification from the Food and Drug Administration (FDA) about the Agency's plans to scale back by 40% the number of domestic routine surveillance inspections that it conducts in fiscal 2014 and 2015.

The BPTF, a US association for manufacturers of active pharmaceutical ingredients, excipients and intermediates, said in a letter to the FDA that it is 'of great concern' that the number of domestic inspections that the FDA carries out will be cut 'in order to elevate the number of foreign inspections'.

Reducing the inspection rate by 40% could cause more than half of US-based API manufacturers to fail to receive an inspection within the three-year cycle, the BPTF said.

'We wish to bring it to the Agency's attention that such a situation would significantly penalise the most cGMP-compliant API manufacturers as well as their customers, the manufacturers of the finished dosage form drug products,' the association said.

Such a situation would significantly penalise the most cGMP-compliant API manufacturers

In the Overview section of the GDUFA Commitment Letter titled 'Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017', the Summary of Major Program Goals said that the FDA would conduct 'risk-adjusted biennial CGMP surveillance inspections of generic API and generic finished dosage form (FDF) manufacturers, with the goal of achieving parity of inspection frequency between foreign and domestic firms in FY2017'.

As a participant in the GDUFA negotiations, the BPTF said it advocated inspection parity and supported the concept of the Agency performing surveillance inspections of manufacturers on a risk-adjusted basis whereby the FDA considers the compliance history of the facility.

However, the BPTF said the FDA still refers to the inspections as being biennial in accordance with the requirements of the Food, Drug & Cosmetic Act for domestic drug facilities.

John DiLoreto, Executive Director of the BPTF, said: '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.

'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 says it 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.