|A counterfeit of Roche's Altuzan was illegally imported into the U.S.--Courtesy of the FDA|
Federal authorities have unhinged a weak link in the global supply chain that is shipping unapproved drugs to doctors in the U.S. at big discounts. In separate cases, two individuals have pleaded guilty to importing and selling $7 million worth of oncology drugs from Turkey, Pakistan, India and elsewhere that were not approved for use in the U.S.
The pleas come at nearly the same time that the FDA sent a warning to doctors that the cancer drug Altuzan offered by another supplier using a similar come-on was not only unapproved in the U.S., but also a counterfeit. The two disclosures are shedding light on the perils of doctors buying foreign-made drugs and thinking they are getting equal quality at lower prices.
Martin Paul Bean III pleaded guilty to conspiring to import unapproved foreign oncology drugs and selling them to doctors throughout the U.S. through his Boca Raton, FL, business, GlobalRxStore. Between 2005 and 2011, the company sourced the drugs from around the world and had them shipped in bulk directly to Oberlin Medical Supply in San Diego. Oberlin was operated by Maher Idriss, who in March 2012 pleaded guilty to conspiring with Bean's company. Drugs included Eli Lilly's ($LLY) Gemzar, Sanofi's ($SNY) Taxotere and Eloxatin, Novartis' ($NVS) Zometa and Roche's ($RHHBY) Kytril. The drugs were intended for sale outside the U.S. and could not be legally sold in the states. Bean raked in $865,000 with his scheme. Idriss ran Oberlin Medical Supply from 2006 to 2011.
Last week, the FDA said tests of the Altuzan sold to doctors by Medical Device King in New York found that it had no active ingredient. Altuzan is the trade name in Turkey for essentially the same Roche drug that is sold as Avastin in the U.S. A year ago, the FDA first warned providers that counterfeit Avastin had been discovered. The FDA and law enforcement officials began targeting online sites that sell unapproved drugs and prosecuting the individuals who ran them.
Authorities also have nailed some doctors who bought unapproved drugs. Dr. William R. Kincaid, the principal owner of McLeod Cancer and Blood Center in Knoxville, TN, was among those charged. Kincaid pleaded guilty to charges of "receiving misbranded drugs with the intent to defraud or mislead." His practice purchased $2 million in misbranded drugs from a Canadian wholesaler to save money and then charged federal health programs full price.
- read the FDA release