Federal inspector general calls for better oversight of foreign drug trials

The U.S. Department of Health and Human Services has, for the first time, counted the number of human drug trials conducted outside the United States.

The U.S. Department of Health and Human Services has, for the first time, counted the number of human drug trials conducted outside the United States.

Critics of the outsourcing wonder if the foreign-trial results should be used in this country.

More and more drug makers are setting up offshore drug trials to test the safety and efficacy of their medicines.

Duke University health economist Kevin Schulman says the U.S. Food and Drug Administration uses drug-trial results to determine if a new medicine can be sold in the United States. He says offshore trials may be perfectly adequate, but it’s just not clear if everyone in the world responds to medicines in the same way.

Schulman: If it was a patient recruited to a clinical trial in South Asia, who had never been treated for diabetes before, he might respond very nicely to a new medicine. That doesn’t mean that the patient in the United States who’s already failed three medicines can respond at all.

Of the drugs approved for sale in the U.S. in 2008, 80 percent had trials in foreign countries, according to the new report.

Most of the foreign trials were conducted in Western European countries.

Testing a drug outside the U.S. is legal, and that move can save money and get a product to market more quickly.

Critics say the FDA needs to keep better track of the trend.

Medical ethicists say they’re worried about patient safety. In 2008, the FDA audited less than one percent of all outsourced clinical trials.

Schulman wants the federal government to step up its oversight.

Experts say companies are allowed to register their trials, and ask for FDA approval, after their testing is complete, and that gives government regulators little ability to keep track.