Report Identifies FDA’s Weaknesses In Monitoring Foreign Drug Trials

The FDA inspected 0.7 percent of foreign clinical drug trial sites in 2008 while 80 percent of applications approved for marketing that year contained data from foreign drug trials, according to a report (.pdf) from the Inspector General of HHS, CBS News reports (Strickler, 6/22).

Companies such as Pfizer and GlaxoSmithKline “have increasingly diversified the patient populations enrolled in their studies” for more than a decade, the Associated Press reports. “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 … 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,” according to the AP (Perrone, 6/22).

The FDA was “16 times more likely to audit a domestic site than a foreign one,” report investigators found, the New York Times writes. HHS Inspector General Daniel Levinson “pointed out that the agency was often unaware of foreign clinical trials as they were being conducted. As a result, federal regulators have no ability to ensure that patients in these trials are being protected while the research is continuing,” the newspaper notes.  

“I think this report just confirms the potential problems with foreign trials,” said Adil Shamoo, editor in chief of Accountability in Research, a journal about research ethics. “There is less liability, patient recruitment is far easier, the concept of informed consent is not well established, and it’s cheaper,” he said, according to the New York Times (Harris, 6/21).

“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,” the AP reports (6/22).

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