The Food and Drug Administration has few details about the dramatic rise in overseas drug testing and reforms are needed to protect both foreign patients taking experimental medicines and Americans who buy products based on their results.
The number of pharmaceutical researchers working outside the United States who voluntarily report their experiments to the FDA increased 16-fold from 1990 to 1999, dwarfing the agency's ability to inspect the test sites. More worrisome, is that the FDA does not know how many such tests are not reported. " It's a serious problem, it's growing, there needs to be something done about it right away," George Grob, a deputy HHS inspector general, said.
In recent weeks, the FDA has opened a criminal investigation into irregularities in a Nigerian drug trial sponsored by Pfizer Inc., and the families of 30 children who participated in the study have filed suit against Pfizer in New York. The FDA is unable to ensure that trial participants in those countries receive the same level of protection as those in the United States.
The FDA has little idea where research takes place overseas, what level of ethics review exists, how foreign researchers recruit participants or how many patients are taking experimental medicines.