WSJournal. Illicit Botox Sparks Alert

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Regulators said last week they warned 350 medical practices that they may have purchased unapproved—and potentially counterfeit—versions of the drug Botox from a network of wholesalers controlled by Canada Drugs, an international supplier linked earlier this year to fake cancer medicines.

The warnings mark the fifth time the U.S. Food and Drug Administration has alerted doctors of suspect, overseas drugs this year, largely sold by Canada Drugs' companies. In February, the agency first told cancer doctors that they had bought a cornstarch and acetone-based imitation of Avastin, a Roche Holdings AG ROG.VX +0.86% medicine, from the network. More than 500 American doctors have now received warnings.

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A sample of Botox

Canada Drugs, a 10-year-old Internet pharmacy based in Winnipeg, has profited for years by selling cheaper, foreign versions of medicines from price-controlled markets such as the U.K. and Turkey to American customers and doctors. But the FDA considers the activity illegal, even when the drugs are authentic medicines, because those drugs aren't approved by the agency. That business, as the Avastin episode showed, introduces the risk that fake medicine may reach American customers.

The agency sought unsuccessfully to shut down Canada Drugs' consumer-focused website in September, and is investigating the company, officials said. Canada Drugs executives didn't respond to a request for comment. Canada Drugs' employees earlier acknowledged in interviews that they shipped the fake Avastin but said they didn't know it was counterfeit.

And, in a sign a broader crackdown on illicit medicines is gaining momentum, drug makers are forging a deal with international police group Interpol to fund some law-enforcement efforts.

Administrators at two medical practices identified by the FDA as buyers of the suspect Botox said sales representatives from Quality Specialty Products, Bridgewater Medical, and other Canada Drugs-owned companies pitched doctors' offices discounted vials of the medicine.

"They said it was the same Botox that Allergan AGN -1.22% sells, but it was not made in the United States," said the practice manager of a small Illinois neurology practice who ordered Botox from Bridgewater Medical. "I was assured it was the same product, but it was just less expensive." The practice ceased ordering the product after a doctor became aware it was of foreign origin, the manager said. Allergan Inc. makes Botox.

These medical-practice employees declined to speak for attribution, saying they didn't want to draw negative attention to their employers. More than a dozen other practices declined to comment or didn't return phone messages.

Quality Specialty Products, Bridgewater Medical and other purveyors of suspect Botox identified by the FDA are either companies acquired by Canada Drugs or trade names used by its representatives, according to business documents and former Canada Drugs employees.

A series of incidents in the past year stretching beyond Canada Drugs underscored gaps in the U.S. drug-supply chain's security. Executives for at least three other drug wholesalers that allegedly sold foreign medicines in the U.S. have been charged with crimes in recent months.

A Tennessee oncologist pleaded guilty last month to a felony count of buying an unapproved cancer drug with the intent to defraud the state's Medicaid program and other health-care purchasers. The oncologist, William Kincaid of Johnson City, Tenn., could face up to three years in prison.

Drug makers and law-enforcement officials have been working for several years to crack down on counterfeit and foreign, misbranded medicines. Since February, Congress has sharpened penalties for selling fake drugs. And pharmaceutical-industry executives have pushed hard to accelerate the efforts.

"The Avastin case has put some wind behind some sails here on enforcement," said Bruce Longbottom, an Eli Lilly LLY +0.61% & Co. trademark lawyer focused on drug diversion and counterfeiting.

As part of the industry's growing enforcement efforts, Merck MRK -1.52% & Co. "began hiring former officers of U.S. and foreign intelligence services, such as the Central Intelligence Agency, building greater capabilities to address the international counterfeit threat to patient safety," said Grant Ashley, security chief for the Whitehouse Station, N.J., drug maker.

In the Interpol deal, a group of 27 drug companies would finance some of the police organization's efforts to crack down on illicit medicine sales, drug-firm security officials and law-enforcement officers say. In the unusual arrangement, Interpol would use the industry money to pay for training for local law enforcement and efforts to track cases in which culprits operate in several nations.

That deal is expected to be completed early next year, officials said. "This is an innovative solution in addressing a global crime problem, and one which most importantly will significantly contribute to protecting the health and safety of people throughout the world," Interpol spokeswoman Rachael Billington said.

In the latest cases, the FDA said it hadn't confirmed whether any patients had received the suspect versions of Botox. It said the products were unapproved, meaning they weren't manufactured at FDA-inspected facilities and packaged for U.S. sale. "If the FDA confirms any counterfeit products, we will notify the public," said spokeswoman Sarah Clark-Lynn.

A spokeswoman for Allergan said the company learned of the suspect Botox vials from the FDA last week. In a statement, the company said, "[w]e cannot confirm the safety or authenticity of products that are imported from unauthorized distributors."

Botox, or Botulinum toxin, is known for its cosmetic use, in which doctors inject it into muscles to relax frown lines and wrinkles. About half of the product, though, is sold for therapeutic uses, including treatment of migraines and urinary incontinence, the company said. Allergan sells genuine Botox to doctors for $525 per vial.

Fake and foreign Botox has appeared before in U.S. medical practices, court records show. In 2006, Chad Livdahl, owner of an Arizona distributor, was sentenced to nine years in prison for crimes related to the marketing of unapproved versions of Botox that the FDA said temporarily paralyzed some patients.

Mr. Livdahl, who was released early in 2009, didn't respond to requests for comment through his attorney. The attorney, Maria Elena Perez, said he maintained "his Botox never harmed anyone."

Write to Christopher Weaver at christopher.weaver@wsj.com