CONCERNED ABOUT THE SAFETY OF FOOD, DRUGS, MEDICAL DEVICES, AND OTHER IMPORTS SCREENED BY THE FDA

Washington, Apr 12 -

“Products regulated by the Food and Drug Administration (FDA) are brought into the country by more than 130,000 importers, with food, drugs, and other products shipped from over 150 countries,” stated Rep. Cliff Stearns (R-FL), Chairman of the Energy and Commerce Committee’s Oversight and Investigations Subcommittee. 

“Inadequate screening of these products can have fatal consequences; last month, FDA Commissioner Margaret Hamburg, M.D., estimated that over 80 Americans had died from contaminated batches of imported heparin (a blood thinner) from China in 2008,” added Stearns.   “I will look into the FDA’s import screening processes and its overall efforts to maintain effective screening controls for imported items.  In addition, the FDA has been working on a risk-based automated import examination system.  This PREDICT (Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting) system has only been deployed in four of the FDA’s 20 districts – I want to ask when PREDICT will be deployed to all districts to better safeguard the American people.”

The Oversight and Investigations Subcommittee is holding a hearing entitled “Import Safety: Status of FDA’s Screening Efforts at the Border.”  The hearing will be held on Wednesday, April 13, 2011, at 10:30AM in Room 2123 RHOB. The single witness will be the FDA Commissioner, Dr. Hamburg.