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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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July 6, 2011: Canadian Doctor Pleads Guilty to Providing Treatment with Unapproved Drugs

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Food and Drug Administration 
Office of Criminal Investigations

 


 

 

             U.S. Department of Justice Press Release 

 

 

For Immediate Release

July 6, 2011

www.usdoj.gov/usao/nyw

United States Attorney

Western District of New York

Contact: Barbara Burns

(716) 843-5817

 

 

           BUFFALO, N.Y.--U.S. Attorney William J. Hochul, Jr. announced today that Dr. Anthony Galea, 51, of Toronto, Canada, pleaded guilty to a felony charge of introducing misbranded drugs into interstate commerce for the purpose of treating professional athletes.  The drugs included human growth hormone (HGH) and Actovegin, a derivative of calf’s blood. Galea entered his guilty plea before U.S. District Judge Richard J. Arcara, and faces a maximum sentence of three years in prison, a fine of $250,000 and forfeiture of $275,000. 

 

            Assistant U.S. Attorneys Paul J. Campana and Mary Clare Kane, who are handling the case, stated that Galea admitted traveling to the United States numerous times from 2007 through September 2009, in order to provide medical treatments to professional athletes, including players in the National Football League (NFL) and Major League Baseball (MLB).  Galea, who is not licensed to practice medicine in the United States, admitted traveling to 13 locations, including New York City, Miami, Washington, D.C., and Boston, to administer four different kinds of treatments.  One type of treatment involved injecting athletes with a mixture containing HGH, while a second type of treatment involved injections of Actovegin. 

 

            Federal law requires that drugs intended for human consumption, such as prescription medicines, must be approved by the United States Department of Health and Human Services, Food and Drug Administration (FDA). HGH is not approved by the FDA as a treatment for sports injuries and is banned by most professional sports leagues, including the NFL and MLB. Actovegin is not approved for any use in humans.

 

            “This Office, along with our law enforcement partners, will not tolerate attempts to breach the integrity of our nation’s borders, or to subvert the border inspection process.  We also stand committed to protecting the health and well-being of our citizens by enforcing regulations which identify the type of substances which may be safely injected into the human body,” said U.S. Attorney Hochul. “Here, the defendant admitted to not only bringing unapproved substances into the country repeatedly, but that he also practiced medicine without a license, supervised criminal conduct of others, and obstructed justice through the actions of one of the defendant’s Canadian employees.  This case should therefore serve as a warning to all that such conduct will be prosecuted.”

 

            “Today’s guilty plea by Dr. Anthony Galea is the result of a thorough and sensitive investigation into his illegal introduction of the unapproved and misbranded drugs Actovegin and Nutropin into American commerce,” said Special Agent in Charge Mark Dragonetti of the U.S. Food and Drug Administration’s Office of Criminal Investigations, New York Field Office.  “With the continued assistance of the United States Attorney’s Office and our federal law enforcement partners, FDA/OCI remains committed to protecting the American public from those individuals who cross our borders with a blatant disregard for the laws and regulations enacted to ensure our health and safety.”

 

            “A key component of ICE’s border security mission is to stop the flow of illegal, misbranded, and unapproved drugs into the United States,” said Lev J. Kubiak, Special Agent in Charge of ICE, Homeland Security Investigations Buffalo office.  “ICE has worked closely with our FBI, FDA and U.S. Customs and Border Protection Partners, as well as Canadian law enforcement partners to include the RCMP, in this important effort to protect the health and safety of the American public.”

 

            "This case began with the excellent work by Customs and Border Protection Officers in the Port of Buffalo,” said CBP Buffalo Port Director Joseph J. Wilson.  “It is also an excellent example of several federal law enforcement agencies working cohesively together toward bringing a case to a successful conclusion."

  

            On June 24, 2010, Mary Anne Catalano, an employee of the defendant in Canada, pleaded guilty before Judge Arcara to making false statements at the border. Catalano is awaiting sentencing in this case.

           

            U.S. Attorney Hochul said the guilty plea was the result of an investigation by Special Agents of the Department of Homeland Security, under the direction of Special Agent in Charge Lev Kubiak, the U.S. Food and Drug Administration, Office of Criminal Investigations, New York Field Office, under the direction of Special Agent In-Charge Mark Dragonetti, and the Federal Bureau of Investigation, under the direction of Acting Special Agent In-Charge Richard W. Kollmar.

 

            Judge Arcara scheduled sentencing for October 19, 2011 at 12:30 pm. Galea was released pending sentencing.