New industry initiative to enhance supply-chain integrity is launched by Amgen

March 19, 2009
Pharmaceutical Commerce, Pharmaceutical Commerce - March 2009,

Rx-360 seeks to bring manufacturers and suppliers together to advance operating standards; meanwhile, Congress gets busy writing bills

Called Rx-360 (rx-360.org), the group is being organized by Amgen but with a specific intention of uniting branded and generic manufacturers, together with their suppliers, “to support an industry-wide commitment to ensuring patient safety by enhancing quality and authenticity throughout the supply chain,” according to a news release.

The group, which will be headquartered in Washington, DC, plans an inaugural meeting there on June 5.

“By building this consortium and bringing together leaders from the pharmaceutical and biotechnology industries, our suppliers and regulatory agencies, we can begin to address more directly and swiftly issues critical to a safe and successful supply chain,” said Martin VanTrieste, advisory committee member and Amgen VP for quality and commercial operations.

The group’s founding is timely, given the rising level of activity in the US Congress. Bills have been introduced to enlarge the “foreign directorate” of FDA (HR 579, "The FDA Globalization Act"); to allow for “re-importation” of drugs from abroad (S.525, “The Pharmaceutical Market Access and Drug Safety Act”); to raise penalties for distributing counterfeit drugs (H.R. 1450, "The Counterfeit Drug Prevention Act"); and last Congress’s HR 5839 (Safeguarding America’s Pharmaceuticals) is expected to be revived.