FOR IMMEDIATE RELEASE                    Contact: Adriana Surfas
Tuesday, April 29, 2008                         (202) 225-3661    

Heparin Case Highlights Need for Drug Safety Reforms at FDA

Washington , D.C. – Congresswoman Rosa L. DeLauro (Conn.-3) issued the following statement about the on-going investigation into the heparin made from counterfeit ingredients.

“Pharmaceutical companies continue to move drug production overseas to take advantage of lax safety standards and lower production costs and then we allow these same companies to police themselves.  In the Heparin tragedy, Baxter assured regulators its self-regulation and compliance inspections were adequate to protect American consumers.  Now we learn that FDA’s inspections of this facility – which occurred only after Americans’ deaths were tied to tainted Heparin and has since been connected to at least 81 deaths – found serious problems.   

“Clearly self inspection is not working.  It is long-past time to give the FDA equivalency standards to regulate the inspection of foreign manufacturers and the ability to levy fines against a company that imports drugs from a facility that has not been inspected by the FDA.

“The tragic stories involving the families who lost loved ones because of contaminated heparin is a stark reminder of how critically important it is to strengthen the FDA so that the inspection process becomes meaningful again.  Families rely on the FDA to ensure the safety of the medications, and more and more people are beginning to question whether the agency is up to the task.”

###

www.house.gov/delauro