The FDA found itself several times in the last few years warning doctors to be on the alert for counterfeit Botox. But the agency said the two men at the top of the drug smuggling food chain have been sentenced after pleading guilty to charges they ran an illegal wholesale operation that distributed counterfeit, misbranded, and adulterated versions of Allergan's ($AGN) Botox in the U.S.
Kamaldeep Sandhu was sentenced to 24 months and Navdeep Sandhu, was given 3 months after pleas that they operated the wholesale operation that ran from Canada to Panama and Turkey. They were said to have sourced foreign-made Botox in Turkey and then shipped it into the U.S. But the way it was shipped posed a danger to patients, since the injected wrinkle remover is supposed to kept refrigerated and their products often were not. The FDA said the packages sometimes were shipped in counterfeit packaging.
The feds tracked down and prosecuted others involved in the scheme, including 41-year-old Dr. Erick Falconer who last year was sentenced to 5 months in prison and 5 months of home confinement for lying to federal agents about purchases of foreign-made Botox made by his St. Louis-area practice, The Youthful Body. Falconer made 50 purchases of the drug after getting a faxed ad with an 800 telephone number and a Gmail account for contacting the seller. The Botox was offered at a steep discount, selling for $354.99 a vial, compared to the $525 it usually costs. When agents questioned Falconer in February 2013, he told them he had made only three purchases of the foreign-made drugs.
Catherine Hermsen, the Special Agent in Charge of the FDA Office of Criminal Investigations Kansas City, MO, office, said that the FDA got help in its investigations from Interpol and the Royal Canadian Mounted Police, as well as the U.S. Marshal's Office.
While the feds have nailed a number of players in this scheme, they have warned that more fake or foreign-made Botox may again be circulating in the U.S. The warning, sent in April, said the FDA had no way of know if the drugs were kept at required temperatures during their shipping, so the product could be contaminated.
- here's the FDA release