Allergan Awaits Finding on Its Export of a Toxin
Allergan Inc. disclosed that it is under investigation by the Commerce Department for exporting a medicine made from a lethal toxin that can be used in biological warfare.
The agency is investigating whether the Irvine-based company exported “botulinum” toxin without a license. The substance, generally associated with food poisoning, can be fatal and is internationally controlled because of its possible warfare uses. Allergan’s drug Botox, made from a purified form of botulinum, is an approved treatment for relaxing severely contracted eye muscles.
The agency requires exporters of such substances to obtain a special “validated” license. For a 15-month period, Allergan sold Botox abroad in many countries on a general export license, rather than a validated one, said Jeff D’Eliscu, a company spokesman. The company, which has since obtained the special license, contends that a federal law exempts medicines from the requirement, D’Eliscu said.
D’Eliscu said the active ingredient in Botox--botulinum toxin--is in the form of a vacuum-dried powder that can’t be made into a weapon. Physicians mix it with saline solution, then inject it into the muscle.
“You can’t use it for anything other than for injecting it into muscles for temporary relaxation of that cramping or ‘spasming’ muscle,” he said.
A Commerce Department spokesman said the agency doesn’t comment on investigations.
After its initial inquiry, the agency referred the matter early last year to the U.S. attorney for possible criminal charges, the company disclosed in a securities filing. The U.S. attorney’s office, which didn’t file charges, returned the matter to the Commerce Department for “its evaluation of possible civil liability,” the filing states.
The agency wouldn’t disclose how many drug companies have run afoul of its licensing controls. However, one legal expert in the field said such actions by the agency involving toxins are rare.
Civil penalties can be minimal, or range up to $100,000 per violation in some cases. In severe cases, a company’s exporting license can be revoked.
Allergan said in its securities filing that it doesn’t expect any potential liability to materially affect its financial position.
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Companies applying for a validated license must submit information regarding the item being exported, its uses and recipients.
In October 1993, the company disclosed to the agency’s office of export enforcement that it had been shipping the drug under a general license since June 15, 1992, when the agency began requiring a special license for botulinum toxin.
The toxin had been listed among those considered useful in the development of biological warfare by the Australia Group, a 28-nation organization that works to stem the proliferation of biological and chemical weapons.
In the U.S. and many other countries, Botox is an approved treatment for neuromuscular disorders that cause the eyeball to be misaligned, or the eyelids to blink uncontrollably or clamp shut. The drug is injected into eye muscles, where it blocks transmission of a chemical that causes them to contract.
The drug is also approved in some countries to treat torticollis, a condition involving uncontrolled cramping and spasms of neck and shoulder muscles.
Allergan has been selling the drug since 1989, when it acquired it from its inventor, a California physician, D’Eliscu said. It has been exporting it since the early 1990s, he said.
Last year, Botox accounted for $48.9 million of Allergan’s worldwide sales, up from $35.5 million the year before. Domestic sales comprised a little more than two-thirds of the total.
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A Toxin That Heals
Allergan’s Botox was the first bacterial toxin approved for use as a medicine. It is a purified form of botulinum type A, a variety of the same toxin that in larger doses causes food poisoning. Details on the toxin and Botox:
BOTULINUM
* What it is: Toxic byproduct from the growth of Clostridium botulinum bacteria and spores
* Where found: Contaminated food, soil, marine sediment
* Distribution: Worldwide
* Toxic effects: Attacks the central nervous system; severe nausea and vomiting are first symptoms. Left untreated, it will cause muscle paralysis and respiratory failure. Antitoxin serum does not cure it, but lessens its severity. No vaccine has been developed.
* Export: Requires special license because it is one of the most toxic substances known and has potential use as a biological weapon.
BOTOX
* What it is: Botulinum toxin type A purified and vacuum-dried into a powder
* Medicinal use: Relaxes severely contracted eye muscles
* How administered: Small doses mixed with saline solution and injected into affected eye muscles; repeat doses required to maintain effect
* How it works: Weakens or paralyzes injected muscles but leaves others unaffected
* FDA approval: 1989
* 1995 sales: $48.9 million
Source: U.S. Food and Drug Administration, Allergan Inc.; Researched by JANICE L. JONES / Los Angeles Times
