The dangers of counterfeit drugs are obvious. They are not going to work. But branded or generic drugs manufactured for use in another country at sites that are not FDA-approved, would still fall into the counterfeit category if used in the U.S. So, while drugs of that nature might theoretically be effective, there are other dangers that may be associated with them, particularly if they are "cold chain" biologics. Take the case of the "gooey mess" that showed up in a doctor's office near St Louis.
James Newcomb was sentenced to 24 months in federal prison after pleading guilty to charges that he shipped foreign versions of prescription drugs to doctors around the U.S. Those included cancer drugs like Rituxan, Herceptin, and Neupogen, that are supposed to be destroyed if they spend than 24 hours outside of their prescribed temperatures.
With help from companies in Canada and the United Kingdom, Newcomb offered the drugs to U.S. doctors at discounts of 14% to 60% off their usual wholesale prices. Reports said the drugs were Turkish versions that are not approved for sale in the U.S. But Newcomb didn't have temperature-controlled shipping, and when a St. Louis-area doctor received a shipment, the drugs were "a gooey mess" and had leaked all over the packaging.
In addition to doing some time, Newcomb is forfeiting $1.4 million in cash and a Land Rover.