The uproar about Heparin, a widely-used drug marketed by Baxter International (NYSE: BAX), is just beginning. As The Wall Street Journal writes "Baxter said the active ingredient for its heparin was supplied by Scientific Protein Laboratories with a manufacturing facility there and a joint-venture operation called Changzhou SPL in Changzhou, China." Tainted heparin has been blamed for four deaths and a larger number of illnesses.
The FDA claims it does not have the inspection capacity to monitor drug components made at facilities around the world and China is one of the largest supplier nations. So, what is to be done?
First and foremost, the companies which make the drugs should be required to provide their own inspections, using specific FDA guidelines, on a regular schedule. The results of these efforts should be forwarded to the FDA for approval. This would require less manpower on the agency’s part than trying to cover the world’s drug supply on its own.
The drug companies would argue that this will be costly and will squeeze margins. That is too bad. The medical community and patients should be able to assume that the pharmaceuticals which they use are safe, no questions asked. Product liability suits are probably more expensive than inspection costs.
Beyond these effort, the FDA should require that every medication, prescription or over-the-counter, carry a label if its has any components which come from facilities in China. If doctors and patients want to make medical decisions based on those labels, then let it be so, even if the treatments are not available from any other source.
Douglas A. McIntyre
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