Washington, DC -
03/16/2012 - Allan Coukell, director of medical programs at the Pew Health Group, today commented on the introduction of a bipartisan discussion draft on U.S. drug safety:
“Thanks to the hard work of a bipartisan working group, we are one step closer to closing gaps in oversight of the U.S. pharmaceutical supply. Since last year, Senators Tom Harkin (D-Iowa), Michael Enzi (R-Wyo.), Charles Grassley (R-Iowa), Richard Burr (R-N.C.), Michael Bennet (D-Colo.) and Sheldon Whitehouse (D-R.I.) have been collaborating to protect patients from risks associated with an ever more complex pharmaceutical production process.
“Just a few years ago, our medicines were routinely made entirely in the United States. Today, however, 80 percent of the active ingredients in U.S. drugs are made abroad. Most of our medicines travel a winding path that passes through raw material suppliers, active-ingredient manufacturers, consolidators, brokers, wholesalers, and intermediates before arriving at pharmacies.
“Under this legislation, Congress would institute reforms that improve the Food and Drug Administration’s oversight of overseas manufacturing and hold the industry accountable for the security and safety of an increasingly globalized and outsourced pharmaceutical supply chain. We look forward to working with lawmakers to further strengthen this drug safety proposal.”