Heparin Shows Structural Inadequacies of the FDA

Press Release

Congresswoman Rosa L. DeLauro (Conn.-3) issued the following statement as the Food and Drug Administration continues to investigate problems associated with the blood thinner drug heparin, made by Baxter International.

"The latest situation involving Heparin highlights the need for better management at the FDA, in addition to more resources, in order to improve the drug safety system. Clearly, there has been a breakdown in the FDA drug safety system if more people have died after being administered the drug, and if this drug still is on the market exposing more people to this risk.

"The FDA seems unable to meet the demands for more foreign inspectors. More distressing is the Administration's refusal to acknowledge the pending crisis and requesting the additional resources required to increase inspections in foreign countries. The Government Accountability Office identified serious problems in FDA's foreign drug inspection program in 1998 and found the same kinds of problems almost 10 years later, in November 2007.

"The FDA has no accurate list of the foreign drug firms that it is supposed to inspect. There is no statutory requirement to inspect these foreign firms, and FDA admits it does so only at the request of the drug companies. And when a violation is found, FDA allows the company to correct the problem, but does not necessarily confirm whether it was corrected.

"Congress has made more resources for the agency a priority - increasing the FDA's budget for 2008 by over $145 million from 2007, including an increase of $21.1 million for drug safety. But clearly, the agency needs more than just resources; they also need better management, less influence from the drug companies and more influence for independent scientists."

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