Baxter Heparin Scandal Points to Continuing Problems at FDAMar 7, 2008 | Parker Waichman LLP
The Food & Drug Administration (FDA) has serious problems, and nothing highlights those problems more than the debacle surrounding tainted Baxter Heparin. The death toll for the Baxter Heparin disaster has climbed to at least 19 people, with many hundreds more having fallen ill after being administered the blood-thinning drug sold by Baxter International. A much delayed inspection of the Chinese plant where Baxter Heparin's active ingredient was processed found "objectionable conditions" and recent lab tests revealed an unknown contaminant in batches of the drug. Investigations still have not yet identified what specifically caused the allergic reactions,
Today, approximately 80 percent of all active drug ingredients come from abroad; however, the FDA has no answer on the percentage of foreign manufacturing facilities it has inspected. Worse, many of these plants are in developing countries that don't have infrastructure that meets U.S. safety standards. In the Heparin case, China said ensuring drug safety is the importing country's responsibility.
The FDA has been under fire for this glaring lack in drug safety for over a decade but has not yet taken steps to correct it, claiming that funding is the main problem. The FDA does not have the resources to meet its statutory mandate to inspect domestic plants every two years, let alone handle the plants overseas. The FDA focuses on domestic companies, with about 1,200 inspections conducted annually in the US; however, only about 300 foreign facilities are inspected annually and, of these, at least10 percent of the firms ship pharmaceuticals here.
In November, the Government Accountability Office found the FDA doesn't know how many foreign firms are actually subject to inspection. The agency has a list of 3,249 firms, but at the current rate of inspection, it would take the FDA over 13 years to go through each firm on its list. The agency also could not confirm how many foreign firms have never been inspected. In those rare cases where the FDA actually does visit foreign plants, officials provide advance warning and rely on translators supplied by the companies being inspected, clearly a conflict of interest that compromises the integrity of the inspections. The FDA has also been criticized for using antiquated, incomplete, and incompatible computer databases. Because of these system problems, FDA officials believed they had actually inspected the Heparin plant in China when, in fact, it had inspected a different plant with a similar name. Funding for foreign inspections fell nearly 30 percent under the Bush administration even though the number of firms requiring inspecting increased.
Clearly, the agency needs more money, either through appropriations or user fees, which under current law can't be used for follow-up surveillance inspections. Because FDA officials won't say how much more money or inspectors are needed—claiming it's not their responsibility to make dollar decisions—no one knows what is needed to correct its problems. It remains unclear why the agency is keeping mum on these issues and many wonder if threats are originating from the Bush camp. Lawmakers—who gave the FDA more money than what was asked for by the Bush administration—can only assist with funding if they are told what is needed.