Govt. Report Says FDA Slack in Oversight of Foreign Drug Trials Used in U.S. Drug Approvals

June 24, 2010

A report by the U.S. Department of Health and Human Services found that prescription drug trials conducted outside the United States and used as a basis for U.S. drug approvals lack oversight by the U.S. Food and Drug Administration (FDA).

A CBS News story about the report revealed that a substantial number of participants and clinical drug testing sites for drugs seeking FDA approval in 2008 were from outside the U.S, yet the FDA inspected less than one percent of foreign trial sites.

The HHS investigation also found the FDA is completely unaware of many foreign clinical trials because sponsors often do not submit an Investigational New Drug (IND) to notify the agency. HHS recommendations to the FDA included taking steps to encourage sponsors to voluntarily consult with the FDA on their clinical trial protocols or submit INDs to the FDA.

HHS Inspector General Daniel R. Levinson will release the report to the public on Tuesday.

According to an article in The New York Times, the F.D.A. was unable to provide HHS investigators with detailed clinical trial data for 29 of the 129 of the approved applications in 2008. For eight of the applications, the agency could not locate any part of the application. HHS recommended the FDA require all data submitted by standardized electronic format.

“The U.S. Department of Health and Human Services (HHS) Inspector General report challenging the Food and Drug Administration’s (FDA) ability to monitor and inspect foreign clinical trials confirms some of the worst fears about the serious dangers of the escalating globalization of human experimentation,” Dr. Sidney Wolfe of the consumer advocacy group Public Citizen said in a statement.

In 2008, 80% of FDA drug approvals were based in part on foreign clinical trial data. 8% included only foreign study data.

“In addition to the increased dangers to human subjects in many countries because they have less adequate protections than in the United States, there are significant threats to the integrity of the data being generated from these experiments because of the decreased ability of FDA to monitor and inspect foreign sites,” Wolfe said. “As a result, 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, jeopardizing the health of people in this country and elsewhere. Massive marketed use of drugs that possibly should not have been approved extends the dangers beyond the subjects of the clinical trials to the general public.”