This week Ohio Senator Sherrod Brown sent a letter to the FDA challenging them to evaluate the level of outsourcing by U.S. Pharmaceutical companies, and the impact of that outsourcing on Drug Safety. He also asked Pfizer, who admitted outsourcing 17% of their API ("Active Pharmaceutical Ingredient"), to make public how much money they save by doing so. Sherrod Brown Press release and letters.

Now the FDA has announced that it will spend taxpayer money to set up inspection offices in China and India. (Three offices in China this year, followed by offices in India. Story here.) It seems to me that the drug companies that profit from overseas operations and the lax or total absence of controls and inspections should pay for these offices and the cost of inspecting the foreign operations.

Senator Brown is absolutely right to dig into this issue that is so critical to the health and safety of our citizens. As he stated to Janet Woodcock, head of the FDA:

You also asserted that FDA must have the tools to hold drug companies accountable when they outsource. What, in your opinion, is the best means of holding these drug companies accountable? All parties throughout the drug supply chain should be held accountable for the quality and integrity of the products they produce.

I seriously doubt that the current FDA will hold drug companies accountable. But they must do so. And those injured by the failure of the drug companies to perform their duties must be able to obtain full and fair compensation from the drug companies that have failed to provide products that are safe and effective.

Thank you Senator Brown. Please keep challenging the FDA, Pfizer, and the rest of the phamaceutical industry to do their duty. And please give those persons and families who are injured and killed the ability to seek full compensation. It is ridiculous to protect these companies from liability on the basis that the FDA is doing its job.

As we have seen in the Heparin Disaster, and as I pointed out in my blog yesterday, the Chinese operations, subcontractors and joint ventures of these drug companies are flying under the radar of the FDA. Even when the FDA tries to inspect these companies they cannot do so.

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