Issue Date: January 14, 2008
Evolution of Imported Drugs
This is a response to the editorial "Pharma's Evolution" (C&EN, Nov. 26, 2007, page 3) and to two articles appearing in the same issue "Risks from Foreign Drug Imports" (page 38) and "Shopping the World" (page 13). All three make it clear why U.S. firms shop all over the world for drug substances, drug products, and contract research organizations—price. Is that enough to put patients at risk?
If the Food & Drug Administration could inspect only 13 of 714 Chinese and 65 of 410 Indian drug exporting firms during fiscal-year 2007, then these drugs are either okay by FDA standards or they should not be coming into our country. Perhaps there are trade agreements outside the control of FDA that allow this. But if these drugs are okay, why does FDA find fault with U.S. drug manufacturers who are likely in superior shape compared with these foreign exporting firms?
I do not think the solution is more money and more personnel for FDA. The bigger FDA gets, the less efficient it will be. The answer may be to stop spending so much to regulate U.S. manufacturers and either concentrate on the foreign importers or do not allow their products entry at least until an inspection has been held. As for U.S. firms, they are convenient, easy to inspect, and give a feeling of accomplishment to FDA personnel who find problems.
We as a society should stop criticizing the U.S. drug industry for its pricing. You can get cheaper drugs, but at what risk? Of course, if you are injured, you can always hire a lawyer to sue the drug firm. And if you drive them out of business, I'm sure China and India will be happy to fill in.
Robert A. Jerussi
Thanks to Bette Hileman for her excellent article "Risks from Foreign Drug Imports." It was both informative and very depressing. I suddenly felt the need for some Prozac but then wondered where in the world it was manufactured? At least when I buy clothes, a label identifies the country of origin. I should certainly have that information when buying drugs.
Allen A. Denio
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