An overwhelmed FDA is a danger to us all

For the first time, FDA commissioner Dr. Margaret Hamburg is publicly addressing the growing problem of monitoring the safety of imported food, drugs, and medical devices in her new report, Pathway to Global Safety and Quality. Currently, more than 80 percent of active pharmaceutical ingredients (API) sold in the U.S. are manufactured overseas, and in 2008, government officials estimated it would take the FDA 13 years to inspect each foreign drug manufacturing plant.

Dr. Hamburg s report states that the safety of America s food and medical products remains under serious threat, and mentions just a few instances of the consequences of the agency s current lack of resources for safety inspections, including the tainted heparin that caused over one hundred deaths in 2008. In fact, that episode was surely just the tip of the iceberg. Currently, nearly two-thirds of all produce and three-quarters of all seafood are foreign imports.

This report, in large part, is meant to frame the issue so that all of our colleagues inside the FDA and external to the FDA really understand how much the world has changed and the necessity of how much we do business in the FDA has to be dramatically transformed, Dr. Hamburg told The New York Times in an interview.

ACSH's Dr. Gilbert Ross suspects that this report was inspired by the recent Republican-driven proposal to cut the FDA budget, since the FDA Commissioner has been silent on these problems for over two years now. Unfortunately, the FDA is woefully understaffed and underfunded to handle the huge volumes of drugs, drug ingredients, and foods being imported from all corners of the world, he notes. I greatly fear that further cuts to the FDA budget would be exactly the wrong thing to do. However, I think the key word in the report s title is pathway, because there don t appear to be any solutions provided in the report, except the possibility of adding more staff and fostering more global cooperation. The FDA is responsible for regulating about 25 percent of the U.S. GDP, and without major supplementation to both financing and manpower, this situation can only become more dire.

ACSH s Dr. Josh Bloom reminds us that, in 1976, when the U.S. began offering tax breaks to drug companies to manufacture their drugs in Puerto Rico, FDA inspections routinely revealed quality control issues there. One can only imagine what s going on in India and China, where much of this manufacturing now takes place. Without adequate (or any) inspections, relying on imported untested imported food and drugs is a disaster waiting to happen.