Manufacturers, FDA Seek to Secure Supply Chains - International outsourcing and rising theft spur regulatory action and manufacturer oversight. - BioPharm International


Manufacturers, FDA Seek to Secure Supply Chains
International outsourcing and rising theft spur regulatory action and manufacturer oversight.

BioPharm International
Volume 23, Issue 6

One industry initiative is the Rx-360 consortium, which provides a forum for companies to share information on supply problems and to develop standards and best practices for supplier audits. This group of some 40 manufacturers and suppliers recently launched a shared-audit pilot program, explained Amgen Senior Vice President Martin van Trieste at the PDA workshop. Such collaboration has been limited, though, by fears that exchanging audit information could violate US antitrust laws. The group is looking for advice from the Justice Department on parameters for sharing audit reports legally.

Another FDA priority is to develop standards and validated technologies to better secure the drug supply chain, as required by the FDA Amendments Act of 2007 (FDAAA). The FDA issued guidance in March that establishes a standardized numerical identifier (SNI) for prescription drug packages. The standard uses a serialized national drug code combined with a unique serial number to identify individual drug packages, but does not require expiration date or lot or batch numbers, a choice made to reduce the SNI's complexity. Certain biologics that do not use NDC numbers, such as blood and blood components and minimally manipulated human cells, tissues, and cellular products, can have an SNI based on other recognized standards such as ISBT 128.

The drug package SNI is a first step in developing a uniform system for tracking and tracing pharmaceuticals through the product life cycle. Almost daily, technology vendors are announcing new tracking and authentication methods that can verify product movement and quality through the supply chain. Companies also are developing tools and best practices for dealing with suppliers, such as scorecards with standardized data and nomenclature, as well as templates for supplier quality agreements.

A parallel initiative is for manufacturers to clarify policies and terms for disqualifying suppliers who fail to maintain secure supply chains. Unfortunately, changing the source of active ingredient or components for licensed drugs and biologics requires prior approval by FDA, which can take months. Manufacturers often opt to continue working with problem suppliers rather than to go through the supplement process, but that appears to be changing with increased focus on product quality.

Efforts to curb the import of counterfeit and adulterated medical products could be undermined, though, by continued pressure to permit reimportation of low-cost drugs from other countries. Senator Byron Dorgan (D-SD) and Montana Governor Brian Schweitzer have requested federal permission to import drugs from Canada for these two northern states, but the FDA maintains that such a program could facilitate drug diversion and counterfeiting. At a Senate budget hearing in March, Commissioner Hamburg told Dorgan that there are "genuine safety concerns" about drugs imported outside the regulated supply chain. But some politicians and consumers dismiss these claims as an industry ploy to keep out cheaper competition.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,

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