Allergan Settles Toxin-Export Allegations
Allergan Inc. agreed to pay $824,000 to settle federal allegations that it improperly exported medicine made from a lethal toxin that can be used in biological warfare, the Commerce Department said Monday.
The penalty is the largest since international controls on biological exports became law six years ago, the agency said.
The Commerce Department alleged that it found 412 instances where the Irvine drug company shipped botulinum toxin--a potentially deadly substance generally associated with food poisoning--without a special license.
Iran and several other Mideast countries received the product, which Allergan sells as an injectable muscle relaxant.
F. Amanda Debusk, assistant secretary for export enforcement, said the Commerce Department doesn’t know whether any of the product fell into the wrong hands. “There is no way we can say with absolute certainty,” she said.
Agency personnel tracked packages sold in Japan, the United Arab Emirates, Lebanon and Jordan and found no evidence that any had gone astray, officials said.
However, they expressed concern about packages shipped to any country that could be sent on to unfriendly nations.
The agency alleged that Allergan failed to abide by controls on biological agents set by the 30-nation Australia Group, whose members work to stem proliferation of biological and chemical weapons.
All members require special licenses to export biological agents that have legitimate civilian uses as well as possible uses in warfare.
The company--which has quit shipping to Iran and other countries that don’t follow the Australia Group’s controls--settled to avoid costly litigation, said Allergan spokesman Jeff D’Eliscu. He said the product--called “Botox” or “Oculinum”--can’t be converted into a weapon of mass destruction.
The company believes the product, as a medicine, should be exempt from export controls, he said. The product, which is injected into a cramping muscle, is approved for the treatment of eyes and eyelids in the U.S. and is also sold elsewhere for the treatment of neck and shoulder muscles.
The settlement surpasses a $480,000 penalty that St. Louis-based Sigma Chemical Co. agreed to pay in July 1996 for alleged violations of export controls. The shipments in Sigma’s case involved several toxins.
