U.S. Inquiry of Drug Makers Is Widened

In an attempt to skirt US laws, pharma is expanding their promotional and approval model to countries where the is no federal oversight and no governing laws.

Of even greater concern to prosecutors in the United States are unusually large payments made to foreign doctors who oversee the growing number of clinical trials that drug and device makers conduct abroad, according toKirk Ogrosky, a former top federal prosecutor who now represents drug and device makers at a Washington law firm.

More than 80 percent of the drugs approved for sale in 2008 involved trials in foreign countries, and 78 percent of all people who participated in clinical trials were enrolled at foreign sites, according to a recent investigation by Daniel R. Levinson, the inspector general of the Department of Health and Human Services. Medical ethicists have long worried that many of these trials are conducted in countries that federal auditors rarely visit and where research controls may be scant.