INVESTIGATES THE DELAY IN PROMISING NEW SYSTEM – PREDICT – TO SAFEGUARD THE PUBLIC

Washington, Apr 13 -

“The Food and Drug Administration (FDA) is charged with the grave responsibility of screening imported food and medicines that the American people increasingly rely upon for their health and quality of life,” noted Rep. Cliff Stearns (R-FL), Chairman of the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee.  “This screening has become a matter of life and death with the death of over 80 Americans in 2008 resulting from contaminated heparin, a blood thinner, imported from China.”

Stearns also focused on the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system, a program to comprehensively and intelligently screen all food, drugs, and medical products entering the United States.  The PREDICT system considers everything from whether a product is intrinsically risky to information acquired from previous sample analysis, field examinations, or inspections.  These and other factors are weighed to develop a risk score that allows FDA to best utilize their resources to target shipments that pose the highest risk.

Stated Stearns, “Despite promises to begin deploying it nationwide by late-2009, and to have it fully up and running by Spring 2010, PREDICT has only been deployed in three of the 19 district over the last 14 months.”  The witness, FDA Commissioner Dr. Margaret Hamburg, cited “Technical difficulties with our information technology” for the delay, and later stated, “I am pleased to report that our nationwide rollout is back on track.”  Stearns asked if PREDICT would be deployed nationwide by the end of the year, to which Dr. Hamburg responded, “That is our absolute goal.”

Stearns also asked about a work plan from the FDA that shows man hours devoted to food import has declined.  Stearns said, “President Obama has talked about food safety being one of his top priorities…Yet, when you look at import food in general on this line in the work plan for FTEs (Full Time Equivalencies)…it appears that in 2009-2010 it has actually gone down.”   Mr. David Elder, Chair, Import Implementation Team at the FDA, answered for Dr. Hamburg,  “It does reflect a 0.7 FTE decrease from the previous year, it is not the only program; however, in which we cover imported food.”  Responded Stearns, “You would agree that this is the biggest program that you have…to see the top program actually go down in man hours in terms of the FDA work plan is quite startling.”