Big Pharma has been riding the outsourcing wave for years now. Why not the FDA? The agency says it's looking to farm out more inspections of foreign plants, as it aims to expand oversight in the rapidly growing world of overseas manufacturing.
FDA has been inspecting foreign plants every nine years, on average, compared with every 30 months in the U.S., Bloomberg reports, and the agency needs to improve those stats. In fact, FDA is under orders to do just that: Congress chastised the agency for its major lag in foreign inspections and upped funding for their expansion.
But perhaps the additional resources weren't enough to keep the work in-house. "We recognize that third-party inspection programs need to be a bigger part of the discussion because we can't do all the work ourselves," FDA's John Taylor said at a conference. "We're looking at anything, anything and everything that will allow us to leverage our resources better."
Of course, foreign manufacturing continues to grow, partly because of the aforementioned outsourcing by Big Pharma. To make up its shortfall, FDA won't just need to catch up on back inspections, but somehow oversee all the new plants popping up around the world--and all the plants operated by Big Pharma's new global partners. The ones that aim to export to the U.S., at least.
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