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FDA Believes Blood Thinner Contamination Deliberate
The Health Section of the New York Times yesterday covered the House Subcommittee on Oversight and Investigations hearing on a contaminant in blood thinner heparin that caused 81 deaths. Federal regulators now believe the contamination was deliberate. In addition to testimony from scientists and federal investigators, the Oversight Subcommittee heard testimony from family members of those who died.
The NYT reports:
David G. Strunce, chief executive of Scientific Protein Laboratories, the company that supplied contaminated heparin material to Baxter International, which manufactured and distributed the finished drug, described the contamination as “an insidious act” that “seems to us an intentional act upstream in the supply chain.”
The F.D.A. has identified Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated heparin. A Congressional investigator said the contaminant, oversulfated chondroitin sulfate, cost $9 a pound compared with $900 a pound for heparin.
Mr. Strunce said that his company tried to find the original source of the contamination but was stopped by the Chinese authorities.
It is no longer realistic to expect the FDA to make informed decisions if it does not have the resources to undertake foreign inspections. Yet, despite what the NYT describes as “a growing bipartisan consensus on Capitol Hill that the F.D.A. needs a rapid increase in its budget to ensure the safety of the nation’s drugs, medical devices and food,” the Bush Administration’s proposed budget increase for next year is “not enough to cover even its expected cost increases.” (The Bush Administration is proposing a 3% increase.)
The FDA regulates products accounting for 25 cents of every dollar spent by consumers. It plays a hugely important role, and we are rightly outraged when contaminated blood thinner (or toxic plastic) is missed. We are also rightly outraged by reports of corruption and big pharma influence. But how much of this is an internal FDA problem, and how much is a larger symptom of the Bush Administration? How can the FDA do its job properly if it is laboring under an administration that encourages political interference in its affairs (remember the Plan B contraception debacle?) and does not give it the financial means to do its job?
Sirine Shebaya, Ph.D. is a Greenwall Fellow in Bioethics and Health Policy at the Johns Hopkins Berman Institute of Bioethics.
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