Inspections, Compliance, Enforcement, and Criminal Investigations
October 6, 2010: Chinese Company, CEO Admit to hGH Smuggling; Pay $7.5 Million in Assessments and Forfeiture
GeneScience Pharmaceutical also Forfeited $2.7 Million Seized from Banks
PROVIDENCE, R.I. – A Chinese drug manufacturer, GeneScience Pharmaceutical Company, and its CEO, Lei Jin, pleaded guilty today to illegally marketing human Growth Hormone in the U.S. The company and Jin jointly forfeited $4.5 million as a result of the criminal charges and will pay an additional $3,000,000 to finance a Clean Competition Fund designed to counter the effects of illicit doping in sports.
United States Attorney Peter F. Neronha, Mark Dragonetti, Special Agent in Charge of the Food And Drug Administration, Office of Criminal Investigations, William P. Offord, Special Agent in Charge of the Internal Revenue Service, Criminal Investigation, and Robert Bethel, Inspector in Charge of the United States Postal Inspection Service, jointly announced the guilty pleas. The defendants entered the pleas before Chief U.S. District Court Judge Mary M. Lisi in U.S. District Court, Providence.
In addition to the criminal forfeiture and assessments imposed today, the company previously forfeited $2.7 million dollars linked to its hGH smuggling. Federal agents seized that money in 2007 from New York branches of Chinese banks in which GeneScience maintained accounts.
At the plea hearing today, Assistant U.S. Attorney Adi Goldstein said that Jin, through GeneScience, used the Internet to market hGH under the company’s brand name, Jintropin. Persons in Rhode Island and elsewhere in the United States purchased the hGH and then redistributed it to others. GeneScience never obtained approval from the FDA to market Jintropin in the U.S., where hGH is available only through doctor’s prescription for strictly defined uses.
U.S. Attorney Neronha said, “HGH, when distributed and used unlawfully, poses a serious health threat, particularly to young people who ignore the risks of such substances in an effort to enhance athletic performance. Today’s guilty pleas and sentencings address this threat in two ways. First, the defendants paid directly for their misconduct through the forfeiture of significant assets, totaling $7.2 million in illegally gained profits, which will deter them and others from engaging in this kind of misconduct. Second, by paying an additional $3 million to finance research, testing, and screening, the defendants will pay to counter the effects of hGH and steroid abuse.”
The charges to which the company and Jin pleaded guilty today supplanted an indictment filed against them in 2007. A multi-agency task force anchored by the Food and Drug Administration, Office of Criminal Investigation, developed evidence that resulted in the criminal charges and the civil forfeiture.
Special Agent-in-Charge Mark Dragonetti, of FDA's Office of Criminal Investigations, said, "Today's announcement demonstrates the continued commitment of FDA's Office of Criminal Investigation and its law enforcement partners to aggressively pursue those who sell unapproved and potentially harmful products over the Internet, whether they are located here or abroad. FDA takes very seriously its responsibility to protect the health and safety of the US consumer."
GeneScience today submitted to the Court a check for $4.5 million, made out to the United States Marshals Service, which satisfies the criminal forfeiture judgment.
Under the terms of plea agreements filed with the charges, the company and Jin will jointly pay $1,000,000 per year for the next three years to finance a Clean Competition Fund, which will be used for programs that support anti-doping in sports, drug testing, screening and detection of hGH, steroids and other performance enhancing drugs, and research involving either the appropriate uses of performance enhancing drugs or the health implications resulting from their use.
William P. Offord, Special Agent in Charge, IRS Criminal Investigation stated, "This is an important victory for the American public in federal counter-drug law enforcement.Not only isthe criminal held accountable for the crime, but a significant portion of the proceeds associated with the illegal activity has been seized through the mechanism of asset forfeiture. The mission of IRS Criminal Investigation in narcotics law enforcement is to financially disrupt and dismantle significant drug trafficking organizations through the investigation and prosecution of their members as well as the seizure and forfeiture of assets associated with the crime.”
In addition to FDA, OCI, the task force investigating the case included the Internal Revenue Service, Criminal Investigation, and the U.S. Postal Inspection Service. Immigration and Customs Enforcement and the Drug Enforcement Administration provided assistance.
Inspector in Charge Robert Bethel of the United States Postal Inspection Service said, “The primary objectives of the Postal Inspection Service in this investigation were to rid the mail of illicit drug trafficking, preserve the integrity of the mail and, most important, provide a safe environment for postal employees and the American public. The Postal Service has no interest in being the unwitting accomplice to anyone using the U.S. Mail to distribute illegal drugs.”
Assistant U.S. Attorneys Goldstein and Stephanie S. Browne conducted the criminal prosecution. Assistant U.S. Attorneys Michael P. Iannotti and Milind M. Shah litigated the civil forfeiture.