During the week following a Senate HELP committee hearing September 14 (IPQ “In the News” September 19, 2011), bills were introduced into both the Senate and House addressing FDA’s supply chain oversight capabilities.
The bills focus on different aspects of the supply chain problem and do not contain significant overlap in their specific provisions.
The Senate bill, S.1584, “Drug Safety and Accountability Act of 2011,” introduced by Michael Bennet (D-CO) on Sept. 20, calls for: ● manufacturers to have a quality management plan ● unique identifiers for each establishment ● mandatory recall authority for FDA, and ● equivalency in OTC and Rx quality management and supply chain documentation requirements.
The House bill, H.R.3026, “Safeguarding American’s Pharmaceuticals Act of 2011,” introduced by Brian Bilbray (R-CA) and James Matheson (D-UT) on Sept. 22, proposes: ● providing FDA authority to destroy non-conforming drugs at the border ● measures to assure distribution chain integrity including wholesaler licensing ● requiring FDA to develop standard numeric drug identifiers ● establishing federal track and trace standards, and ● additional injunction and civil penalty options.
[Editor’s note: A link to the supply chain consortium Rx-360’s summary of the two bills is provided below].