Overseas oversight gets serious - FDA trends

The heparin scandal threw into sharp relief just how difficult it is to regulate drug ingredients produced overseas. No one was quite sure where in the supply chain the heparin was tainted, and the FDA and China traded blame over the fiasco. FDA Comissioner Andrew Von Eschenbach didn't escape blame though; he found himself in the hot seat again at a Congressional hearing. The House Committee on Energy and Commerce grilled the agency chief about foreign oversight and scolded him for safety lapses that occurred on his watch, including the big heparin debacle.

While most drugmakers draw ingredients from overseas, the problems with heparin highlighted just how difficult it is to regulate a drug's supply chain from start to finish. With an increasing amount of drugs and drug ingredients being imported from India, China and the like, the need is increasing for more rigorous overseas inspection. In response, the FDA is working to establish five satellite offices in India, China, Central and South America and the Middle East. But the FDA is already running into a nest of red tape with its China office and undoubtedly more problems lay ahead as the FDA grapples with drug safety on a global scale.

One thing is for sure: in the coming years, the FDA won't be caught flat-footed the way they have been recently, and drugmakers better be prepared to deal with tighter regulations.

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