The FDA inspected about one percent of foreign drug testing sites in fiscal year 2008, according to a report issued Tuesday by the Inspector General for the Department of Health and Human Services. The FDA is responsible for looking out for the safety of patients enrolled in studies of all drugs destined for the U.S. market.
However, the inspector found that the FDA was often unaware of early-stage trials conducted in developing countries in South and Central America.
For more than a decade companies like Pfizer Inc., GlaxoSmithKline PLC and others have increasingly diversified the patient populations enrolled in their studies. The benefits of the approach are two-fold: they give scientists a broader picture of how the drug will interact in different patients groups and can also help lower costs.
Western Europe remains the largest venue for foreign testing, accounting for 58 percent of patients enrolled in foreign drug trials. But investigators found that countries in South and Central America had the largest numbers of patients per test site, suggesting drugmakers are eager to pack their test groups with patients from countries with lower operating costs.
Public watchdogs have expressed concern about the quality of studies conducted in countries where the FDA has little or no presence.
"The quality of the data used by the FDA as a basis for approving the drugs being studied may well be flawed, resulting in dangerous, incorrect decisions to approve drugs," said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.
According to the HHS report, roughly 80 percent of drug approvals in fiscal 2008 were based in part on data from foreign studies. Eight percent of drug approvals contained only foreign data.
The report makes a several recommendations to help the FDA oversee foreign studies, including better coordination with foreign governments to monitor drug trials abroad. Regulators should also require drugmakers to submit trial data in a standardized electronic format, to help the FDA identify sites for inspection, the report recommends.
FDA officials said they agreed with the inspector general's recommendations, according to the report.
