US FDA to Monitor Medical Products Overseas

With recent drug troubles such as heparin imported from China, the US government has proposed a Globalization Act to perform more regular inspections of companies that produce food, drugs, and medical devices overseas. In addition to increased domestic inspections, the bill calls for the FDA to inspect foreign facilities by setting up permanent sites overseas.

The US FDA has recently submitted a proposal to fund this new potential bill. The commissioner of the US FDA, Dr. Andrew von Eschenbach, submitted this proposal.

Von Eschenbach’s proposal includes conducting 120 more foreign medical product facility inspections and $5.4 million to support these inspections. The FDA is planning to hire and train additional field inspectors throughout 2008. Other requests include $7.8 million for increasing FDA’s presence beyond its current borders.

As of now, the bill has not been passed. This new bill would also affect US medical companies as user fees for manufacturing sites could potentially increase to fund the overseas inspections. Also, the bill requires inspections not only on finished medical devices, but component manufacturers.

Over the past years, the FDA has inspected high-risk foreign device manufacturers every six years. For medium-risk foreign device manufacturers, FDA inspections have been every 26 years at most.

In 2006, the FDA inspected a little over 215 foreign device manufacturers. Last year, it inspected over 275. However, the FDA said it will need further funding and personnel to comply with the number of inspections proposed in the Globalization Act.