Level of Industry Response to FDA’s Quality Agreement Draft Guidance Reflects Contracting Challenges; Terminology at Issue

The raft of industry comments FDA has received on its draft guidance on “Quality Agreements for Contract Manufacturing Arrangements for Drugs” underscores the importance of having clear terminology when addressing the complexities in the contracting arena.

Given their depth and diversity, the comments will be challenging for the agency to assimilate – with various opinions expressed, in particular, on how the terminology issues should be worked out.

The comments do converge in supporting FDA’s emphasis on the need for a highly collaborative relationship between the parties, and suggestions are made on how to further emphasize these relationships.

The level of attention the draft guidance has received reflects the multidimensional challenges that companies have been wrestling with in their contracting relationships and the compliance breakdowns and product failures that have been occurring. (IPQ, November 1, 2013).

34 separate sets of comments were posted by FDA, received from from 12 associations, 16 companies and six individuals. They range from a single paragraph to almost a dozen pages in length.

Associations submitting extensive comments included the Consumer Healthcare Products Association (CHPA), ISPE, and the Biotechnology Industry Organization (BIO). Briefer comments were submitted by PDA, Europe’s Active Pharmaceutical Ingredients Committee (APIC), and the Generic Pharmaceuticals Association (GPhA).  Among companies submitting more extensive comments were Pfizer, McKesson, and a contract manufacturer that did not identify itself by name.

Along with terminology, areas receiving attention included: ● the scope of the guidance ● requirements around subcontracting ● harmonization with ICH ● responsibility for final product release ● inclusion of the contractors’ procedures in a quality agreement and the need for owners to review them ● communications and confidentiality concerns, and ● laboratory facility requirements.

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