Federal authorities have extracted another guilty plea from a doctor found to be using unapproved foreign versions of drugs on his patients, including Rituxan, Remicade and Prolia. The Kentucky physician, who bought the drugs at a deep discount from the U.K., will pay more than half a million dollars in restitution and has received a year of probation.
According to the FDA, Dr. Mark Heinicke pleaded guilty to a criminal information and agreed to pay nearly $177,000 in restitution in the criminal case. He also settled a civil case with federal authorities and agreed to pay about $338,500 more. Heinicke had used the drugs without telling his patients they were not FDA-approved and then charged Medicare as if they were, the FDA said.
The FDA and other authorities began tracking down people and companies that were importing, or smuggling, unapproved cancer drugs and other treatments after counterfeits of Roche's ($RHHBY) Avastin were uncovered in the U.S. in 2012. But they have also brought cases against some of the doctors and physician practices that bought them knowing they came from outside the legitimate supply chain. The feds point out that doctors who buy foreign-made drugs put their patients at risk. The drugs could be fakes, as some cancer meds have turned out to be, and cold-chain drugs may not have been safely stored and shipped.
In July 2013, a California oncologist and his practice paid $3.4 million in fines for buying drugs from a source in Canada that was not approved by the FDA. The La Jolla, CA, physician admitted giving his patients foreign versions of nearly a dozen different cancer meds, including a version of Roche's Rituxan manufactured for use in Turkey. A Missouri doctor who bought foreign versions of Allergan's ($AGN) Botox last year was given a 5-month prison sentence.
The efforts have also caught some of the companies that were bringing the drugs into the U.S., including in January the owner of a pharmaceutical company in Turkey and his partner, who used false documents to smuggle in Altuzan, the version of Avastin made for the Turkish market. The effort also got convictions of more than a dozen people associated with a Washington, DC-area company, Gallant Pharma, which was shipping drugs into the U.S. from Pakistan, including cold-chain products, after altering the packaging to disguise the fact they were foreign made.
- here's the FDA release