Comment Process on FDA’s Proposed Rule on Product Detention During Inspections Reflects Industry Support

The comment process on FDA’s proposed rule on “Administrative Detention of Drugs Intended for Human Animal Use” as authorized under Title VII of the FDA Safety and Innovation Act (FDASIA) has indicated industry’s comfort level with extending the detention authority the agency already had for foods and devices to drug products.

The proposed rule provides the agency with the ability to detain products if inspection findings raise red flags and is one of the components in the FDASIA toolbox designed to strengthen FDA’s ability to keep substandard drug products out of the supply chain.  To date, the only enforcement option the agency had to forestall product distribution was the slower and more cumbersome seizure pathway, which required court involvement and has been increasingly sparsely used.

The draft rule was originally released in early April with a 30-day comment period, but FDA did not receive any industry feedback and only one ‘nonsubstantive” comment. It was re-released in mid-July – this time with a 60-day comment period – in the hopes of drawing more meaningful industry feedback. The second request for input drew four industry responses: One from a big pharma company – Novo-Nordisk; and three from associations – the Biotechnology Industry Organization (BIO), PDA, and the Generic Pharmaceutical Association (GPhA).

[CLICK HERE for the complete story.  Included is an insider’s view of the anatomy of the FDASIA legislative effort provided by one of its coauthors.  Nonsubscribers can purchase the story for $195 by contacting Karen Bertani (  For subscription/license information, click here.]

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