Malani Argues for Increase in Foreign Clinical Drug Trials

Push for more trials may hurt patients
Anup Malani and Tomas J. Philipson
Washington Examiner
July 21, 2010

U.S. pharmaceutical companies are increasingly going abroad to conduct clinical trials required by the FDA.Recently, the Department of Health and Human Services released a report suggesting that the FDA lacks the resources to adequately monitor these foreign trials. Four of every five new drugs sold in the U.S. are tested in foreign trials, and the FDA inspects less than one in 10 of these. This is half the rate of inspection for domestic trials.

The potential for fraud seems high. In fact, some medical ethicists used the report to insinuate that pharmaceutical companies were deliberately conducting foreign trials in order to avoid U.S. ethical constraints and to experiment on unsuspecting foreign patients.

These concerns are exaggerated and ignore the complexities of modern clinical research. If the FDA and Congress push companies to conduct more domestic clinical trials, foreign patients will lose the often valuable health benefits gained from participation in clinical trials, and domestic consumers will suffer from slower access to new, life-saving therapies.

Critics forget that about half of all foreign trials are conducted in Europe. There, European regulators impose ethical rules on clinical research similar to the FDA's.

The real reason drug companies are conducting more trials in Europe (and Central and South America) is because it is increasingly difficult to recruit patients in the U.S.