FOR IMMEDIATE RELEASE                    Contact: Adriana Surfas
Wednesday, March 12, 2008                         (202) 225-3661    

DeLauro Calls for Heparin Investigation

Washington , D.C.  – Congresswoman Rosa L. DeLauro (Conn.-3), chairwoman of the House Agriculture, Rural Development, FDA Appropriations Subcommittee, urged the Office of Inspector General at the Department of Health and Human Services to investigate the failure of the Food and Drug Administration to conduct a pre-approval inspection of the plant in China that produced the Heparin drug for Baxter.  DeLauro pressed the FDA for answers to the many questions surrounding the Heparin case during a subcommittee oversight hearing “Improving the Drug Safety System at FDA.”

“While FDA has sought to portray this as an isolated incident, we cannot determine whether that was the case until we understand what transpired,” DeLauro writes in the letter.  “If this was not an isolated situation, we need to determine the scope of the problem at FDA and how to address it.” 

Below is the full text of the letter.

March 12, 2008

Daniel R. Levinson

Inspector General

Office of Inspector General
U.S. Department of Health and Human Services
Room 5541 Cohen Building
330 Independence Avenue, S.W.
Washington , D.C. 20201

Dear General Levinson:

            I am writing to request the Office of Inspector General at the Department of Health and Human Services investigate the circumstances surrounding the apparent failure of the Food and Drug Administration to conduct a pre-approval inspection of the plant in China that produced the Heparin drug for Baxter.  The reports about Heparin highlight concerns about the process by which the FDA tracks and carries out foreign drug facility inspections.

            According to initial reports, the Chinese facility that supplies the active ingredient for Heparin was never inspected by the FDA because the agency confused its name with that of another plant.  While FDA has sought to portray this as an isolated incident, we cannot determine whether that was the case until we understand what transpired.  If this was not an isolated situation, we need to determine the scope of the problem at FDA and how to address it. 

            I would strongly recommend that, at a minimum, the following questions be addressed:

·       Why did FDA fail to conduct a pre-approval inspection for this plant?

·       What systems or processes, if any, did FDA have in place to ensure that mistakes like this did not occur and why did they fail 

·       What, if any, safeguards is FDA putting in place to avoid repeating this error, and ensure that the agency does not miss critically needed pre-approval inspections again?

            During a recent hearing on drug safety before the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, I raised many questions about FDA’s failure to take action to address critical shortfalls that were outlined in previous reports from your office.  The subcommittee greatly values the role of the Inspector General and I want to reiterate my support for the work that you do.

            Thank you very much for your consideration of this request.

                                                            Sincerely,

                                                            ROSA L. DeLAURO                                                                                                                          Chairwoman

                                                            House Appropriations Subcommittee on Agriculture
                                                            Rural Development, Food and Drug Administration,

                                                            and Related Agencies

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www.house.gov/delauro