Should FDA outsource inspections?

Is what's good for pharma good for its regulators, too? As we all know, Big Pharma's outsourcing of active ingredients and manufacturing has caused a big bout of hand-wringing on the governmental side as FDA has struggled to keep up--and largely failed. Meanwhile, attempting to keep pace with a boom in overseas device manufacturing, FDA tried imitating its regulatees by outsourcing some foreign device-making inspections. Two years and 12 third-party inspections later, critics have declared the program a flop, and even FDA types are underwhelmed.

Despite those ignominious results, the Bush administration has been pushing a plan to expand private inspections to drugs and other imports. Bills are in various stages of draft in Congress. Whether inspection-outsourcing will ever make it past the draft phase remains to be seen, especially given the fact that in a few months, the Bush administration will be no more, and its zeal for privatization could very well exit the White House along with the boxed-up files. Stay tuned.

- see the Pharmalot post

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