By Mike Lillis - 09/28/10 03:37 PM EDT
Democratic leaders on the Energy and Commerce health subcommittee will meet this week to examine draft legislation designed to ensure the safety of pharmaceuticals in an ever-globalizing world.
The draft bill, unveiled by E&C leaders last week, would enhance the safety and inspection requirements for American-sold drugs manufactured overseas — an effort to ensure that foreign consumer protections are at least as stringent as those in the U.S.
The bill is largely a response to an incident in 2008 when defective, Chinese-made heparin — a blood thinner — killed scores of Americans.
"We’ve learned more than a few troubling truths on the safety of some prescription medications, and we’ve learned it the hard way — with tragedies,” Rep. John Dingell (D-Mich.) said last week in a statement.
"We know we need to address this, the only question now is how. We must ensure the Food and Drug Administration is adequately equipped to carry out the important mission of protecting American consumers."
The hearing is scheduled for Thursday.
Witnesses will include Janet Woodcock, director of FDA's drug research center; William Vaughan, health policy analyst at Consumers Union; Kendra A. Martello, attorney for the Pharmaceutical Research and Manufacturers of America (PhRMA); Allan Coukell, head of medical safety at the Pew Health Group; William Hubbard, with the Alliance for a Stronger FDA; Andrew Emmett, managing director of the Biotechnology Industry Organization (BIO); and Gordon Johnston, vice president of regulatory sciences with the Generic Pharmaceutical Association (GPhA).