Feds nail importers of foreign-made Botox

Botox is a sterile drug that has to be shipped according to strict cold-chain standards. But that didn't much matter to Syed "Farhan" Huda and his employees at Gallant Pharma International, who bought Botox and cancer drugs on the black market and sometimes received them shipped only with ice packs that melted before they arrived.

The co-owner of the Arlington, VA-based company has now pleaded guilty to a host of charges related to buying and selling misbranded and unapproved drugs to doctors in the U.S., according to the FDA. The other owner of the company, Talib Khan, 42, of both Montreal, Canada, and Barbados, and half a dozen employees of the company have already pleaded to charges. Huda's wife, Deeba Mallick, and two others are awaiting trial. The feds also got guilty pleas from a cancer clinic manager in St. Louis, MO, who bought some of the drugs. Huda, who will be sentenced in March, faces more than 50 years in prison.

"Gallant Pharma exploited some of our most vulnerable citizens to make a profit, including those suffering from cancer and undergoing intravenous chemotherapy," said Dana Boente, acting U.S. Attorney for the Eastern District of Virginia. FDA Special Agent in Charge Antoinette Henry added, "Gallant Pharma purchased drugs on the international black market, with no idea whose hands those drugs passed through or what conditions the drugs were stored or shipped in."

Counterfeits of erectile dysfunction drugs sold over the internet used to be the main threat federal officials had to fend off. But as criminals moved up the drug food chain, regulators started finding fakes and foreign versions of drugs like Roche's ($RHHBY) cancer drug Avastin and Allergan's ($AGN) Botox making it into the U.S. Federal authorities have been taking a multipronged approach to deterring the practice. They are not only pursuing importers like Huda but also coming down on physician practices that they find have knowingly bought the drugs to save money.

- here's the Department of Justice release
- more from the FDA

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