Letter to Andrew von Eschenbach, M.D., Commissioner of Food and Drugs
KENNEDY CALLS FOR INVESTIGATION INTO FOREIGN-SOURCED DRUG INGREDIENTS
Today, Senator Edward M. Kennedy, Chairman of the Health, Education, Labor and Pensions Committee, sent the following letters to the FDA and four industry groups urging an investigation into the sourcing of ingredients used in drugs.
The text of the letters are below.
March 19, 2008
Andrew von Eschenbach, M.D.
Commissioner of Food and Drugs
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Commissioner von Eschenbach:
I commend you and the Food and Drug Administration for your investigation of the Heparin tragedy, and I urge you to take additional steps to protect the safety of the nation's drug supply.
At least 19 people have died recently because of reactions to contaminated Heparin, and hundreds have been seriously injured. The FDA has just announced that it has identified a contaminant in Heparin from China that looks like Heparin in the assay used to test the potency of Heparin. This contaminant, an over-sulfated chondroitin sulfate, does not appear to be a naturally-derived compound. It seems likely that it was added intentionally to protect the sales of Heparin. Pigs are the source of Heparin but are in short supply in China because of rampant disease, which may have led to use of the contaminant.
Eighty percent of the active ingredients in our drugs are derived from overseas sources, and 40 percent come from China and India. The FDA does not have sufficient records and databases to enable it to determine where drug companies obtain their ingredients and what they are doing to ensure that the ingredients are pure and potent. I believe the agency could build such databases if drug companies inform you of these sources, and I have written to the major drug industry trade associations asking them to urge their members to cooperate with the FDA on this issue. I would appreciate a written report from you by April 9, 2008, on how the agency and industry members are responding to this request.
I also believe those responsible for the Heparin tragedy need to be held accountable, and I urge you to work with the Justice Department as you continue your investigation and pursue enforcement actions related to this tragedy. Thank you very much, and I look forward to your response.
With great respect and appreciation, as always.
Edward M. Kennedy