Pharma Companies, not FDA, Should Monitor Offshore Suppliers

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Just last month I wrote about an IMS report that predicted that profit-challenged U.S. pharmaceutical companies would offshore more manufacturing, followed by offshoring of other activities including R&D.


This prospect has at least one U.S. senator, Sherrod Brown (D-Ohio), concerned. Brown sent an open letter to the Food and Drug Administration, reports Outsourcing-Pharma.com, asking the agency to ensure it has adequate safeguards to protect consumers from "drug products containing tainted, outsourced ingredients." Writes Brown:

It is no coincidence that drug ingredients produced in countries with weak safety standards are often contaminated. The FDA must immediately review pharmaceutical outsourcing and make necessary changes to keep American consumers safe.

Brown wants the FDA to investigate the amount of pharmaceutical ingredients that come from countries with weaker regulations than the U.S. and to estimate how much it would cost to protect U.S. consumers from tainted ingredients produced in such countries. According to the article, a legislative proposal called the FDA Globalization Act of 2008 would require the agency to inspect offshore manufacturing facilities every four years.


But some experts, including Harvard Medical School professor of medicine Jerry Avorn, think it is unrealistic to expect the overextended FDA to tackle these kinds of inspections. Noting that with its current funding, it would take the FDA more than 13 years to inspect all foreign plants exporting prescription drugs to the U.S. and 27 years to inspect all foreign plants exporting medical devices, Avorn writes in the New England Journal of Medicine:

Criticizing the FDA for failing to stay on top of such inspections when it doesn't have the requisite funds is victim blaming, not policy analysis.

Though it will obviously add costs to their outsourcing initiatives, the pharmaceutical companies themselves should assume the bulk of the responsibility of keeping their suppliers in line. As I've written before, it's an unfortunate fact that overseas companies sometimes deliberately cut corners to boost their profit margins. Companies that outsource manufacturing to China and other low-cost countries must pay special attention to quality control