Life ban for head of illicit medicine importer Gallant

The co-owner of a company that imported misbranded and unapproved drugs into the US has been barred for life from involvement in the pharma industry.

Talib Khan and various associated working at Virginia-based firm Gallant Pharma International pleaded guilty in 2013 to importing intravenous chemotherapy drugs and injectable cosmetic drugs and devices including illegally-imported versions of Allergan's wrinkle-treatment Botox and Galderma's dermal filler Restylane.

Many of the drugs were required to display 'black box' warnings on their labels concerning their temperature storage requirements - indicating there is a significant risk of serious or life-threatening adverse effects if these conditions are breached.

As cofounder and co-owner of Gallant Pharma, Khan was primarily responsible for the international aspect of the conspiracy, including determining which drugs and devices to sell in the US and establishing relationships with international suppliers that shipped the product to the US via Canada and the UK. Around $12m of illicit products were handled by the company over a four-year period.

He was convicted of two felonies in 2014 - introducing misbranded drugs into interstate commerce and criminal conspiracy - and has now been debarred under section 306(a)(2)(B) of the federal Food, Drug & Cosmetics (FD&C) Act.

"Khan was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation [but] failed to respond," said the FDA.

His failure to respond "constitutes a waiver of his right to a hearing concerning this action," confirmed the agency.