Janet Woodcock, deputy director of the Food and Drug Administration, told Rep. Rosa DeLauro (D-CN) on Capitol Hill that the agency doesn't have enough inspectors to monitor all the foreign drugs and drug component chemicals entering the U.S.

I didn't see the hearing. Did Rep. DeLauro ask Ms. Woodcock if the agency has enough lawyers to prosecute the corporations who, to save a few bucks, outsource their production to unsafe/unregulated subcontractors. Perhaps if the corporation whose name appears on the product shouldered the legal responsibility for harm done, we could just 'beef up' the prosecutorial arm of FDA without having to set up inspection sites/inspectors around the world.

If the FDA stopped launching new initiatives like quality risk management, design space PAT and REMS with thousands of new concepts [which are actually old ones with new names] they might have more time to do the dirty and hard task of carrying out proper audits and inspections.

But that is not as much fun

Wasnt it Lenin who said "Trust is good, Control is better"?
There are no doubt effective, compliant suppliers in the Far East but I suspect there are not enough for all those looking for them. My main concern is whether the risk/reward assessments are being applied sensibly. If you buy a pair of shoes sourced from China and the sole falls off, you (and maybe your friends) dont buy another pair. If you injure (or fail to heal) a female breast cancer patient in the USA due to adulterated product I would think you are putting the Company name at risk - headlines like "Dying to save Pharma money" spring to mind. There is enough evidence in the West of a tendancy to cut corners if we can get away with it, so perhaps we shouldnt be 'holier than thou'. It's not like the FDA havent issued Warning Letters before, the need for risk based targetted inspection is critical for all sources of supply. I do wonder whether it could be done more efficiently so that inspection responsibility could be shared between authorities so that the US taxpayer isnt always footing the bill...

Why all the talk about FDA? Baxter is responsible. Baxter dropped the ball by not ensuring that their Chinese and Wisconsin suppliers weren't up to U.S. regulatory and CGMP standards. Yes, the U.S. government's job is to oversee things as much as possible; but, that doesn't excuse companies from having primary responsibility for the products they put on the market.

Chris, you are right about Baxter not fulfilling their responsibility-but remember the significant difference between the US and the Eu. In Europe the finished dosage manufacturer is responsible for checking GMP of the API whereas according to my understanding it is the FDA that accepts responsibility.