US FDA Warned Over Drug Exports Law

The US export reform bill, Bill HR 3019, now requires only "a simple notification" to the Food and Drug Administration of a manufacturer's intention to export unapproved drugs and medical devices, notes a spokesman for one of the bill's GOP sponsors. Any expansion of this by the FDA "will generate significant Congressional interest," Representative Upton's legislative director, Jeff Myers, has warned.

Rep Upton himself told a Food and Drug Law Institute meeting that there should be no FDA requirement that the product to be exported should carry a label to indicate that it has not been approved in the USA. He and the bill's other sponsors are working on a bipartisan letter to FDA Commissioner David Kessler "to make sure that he knows that was not the intent of the legislation," he said, and if the FDA tries to pursue this particular angle, they "will work very diligently" to make sure that it does not happen.

Michele Limoli, special assistant to the director at the FDA Office of International Affairs, said that since the bill was enacted the FDA had received 31 export reports from 20 companies for 34 products. These reports' length and depth varied greatly, and the agency will be using them to evaluate the amount of information it will require in future, she said.