Citing a record 1742 drug recalls in 2009, a 400% increase from 2008, Sen Michael Bennet (D, Colo) introduced legislation designed to enhance the ability of the Food and Drug Administration (FDA) and the pharmaceutical industry to ensure that medications are safe and effective regardless of where they are manufactured.
The bill (S 3690 [http://thomas.loc.gov]), introduced August 3, would enhance the FDA's ability to track and monitor foreign manufacturing sites and give the agency additional recall power and enforcement options, such as assessing civil penalties. The bill also requires companies to institute quality management plans to ensure quality and safety of their drugs, plans that would include stronger supplier oversight and document which entities are involved in the manufacturing supply chain for their drugs.
Mitka M. Improving Drug Safety. JAMA. 2010;304(10):1060. doi:10.1001/jama.2010.1284