Securing the Supply Chain - Pharmaceutical Technology

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Securing the Supply Chain
FDA and industry seek to ensure drug quality and safety in a world complicated by global outsourcing and rising theft.


Pharmaceutical Technology
Volume 6, Issue 34, pp. 28-32

Sharing information


In Washington this month
In addition to identifiers and antitheft action plans, FDA wants industry to communicate more quickly about emerging health risks and supply problems with each other as well as with healthcare providers and regulators. A leading forum in support of sharing information is the Rx–360 consortium, which is moving forward with initiatives to share audit reports and details on supply problems and to develop standards and best practices for supplier audits. The group of some 40 manufacturers and suppliers recently launched a shared-audit pilot program, explained Martin van Trieste, senior vice-president for quality at Amgen, at the PDA workshop. Such collaboration has been limited, though, by US antitrust laws that inhibit how companies may exchange information on business practices and decisions. There's interest among industry and regulators in seeking advice from the Justice Department on how the group may discuss company audit results without violating anticompetition policy.

Legislation that aligns state, federal, and international policies in the supply-chain management area also would support the campaign against drug counterfeiting, diversion, and theft. State licensing requirements for wholesalers and distributors vary considerably, and most states have no curbs on pharmacies that resell drugs from questionable sources such as hijackers. Uniform state licensing requirements and stiffer penalties for trafficking in stolen goods would be helpful. Such items could be included in legislation before Congress that aims to strengthen FDA's authority over imports, support more plant inspections, and establish a uniform electronic pedigree system that can track drugs and medical products through the supply chain. Unfortunately, it may take another crisis such as that with contaminated heparin, for Congress to act, and for all manufacturers to take stronger measures to ensure quality practices in supply-chain management.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,
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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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