Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
February 18, 2010
United States Attorney
Southern District of Florida
Contact: Alicia Valle
Special Counsel to the U.S. Attorney
Jeffrey H. Sloman, United States Attorney for the Southern District of Florida, and David W. Bourne, Special Agent in Charge, U.S. Food and Drug Administration (FDA), Office of Criminal Investigations, Miami Field Office, announced that defendant Arnesto Segredo, 43, of Miami, a former prescription drug wholesaler, was sentenced today by U.S. District Court Judge Alan S. Gold to 70 months in prison. Segredo was convicted in August 2009 of one count of conspiring to divert the prescription drugs Serostim and Nutropin AQ, both human growth hormones, and one count of diverting these human growth hormones in interstate commerce.
The two felony charges against Segredo arose from his role in causing his California-based human growth hormone suppliers, all of which were unlicensed to engage in the wholesale distribution of prescription drugs in California, to regularly ship him hundreds of boxes of Serostim, and some Nutropin AQ, from 2000 through the end of 2002. According to evidence admitted at trial and statements made in open court, from 2000 through 2001, Segredo operated Life Extension Institute, a Miami-based prescription drug wholesaler that was never licensed to engage in the distribution of prescription drugs in Florida. He later operated Genendo Purchasing Organization, a Miami-based prescription drug wholesaler that secured a Florida license in July 2001.
The Prescription Drug Marketing Act ("the Act") was passed by Congress to prevent prescription drug diversion and the distribution of counterfeit, stolen, or substandard drugs. The Act requires that every wholesaler that engages in wholesale distribution of prescription drugs in interstate commerce to be licensed by a State licensing authority before engaging in the wholesale distribution of prescription drugs in interstate commerce.
Serostim is an injectable drug approved by the FDA for the treatment of AIDS-wasting syndrome in HIV-infected patients, and Nutropin AQ is an injectable drug approved by the FDA for the treatment of growth hormone deficiency, including children with short stature. A significant portion of the Serostim that Segredo caused to be distributed originated from AIDS patients in California who obtained their Serostim from the Medi-Cal Medicaid program.
Evidence presented in court during several sentencing hearings before Judge Gold showed that the Nutropin AQ distributed by Segredo was counterfeit. Evidence showed that the counterfeit Nutropin AQ entered the prescription drug supply chain and was ultimately distributed, causing bodily harm to a child. Although the evidence did not show that Segredo engaged in the intentional distribution of counterfeit medication, the Court found that this was a foreseeable risk that could result from the illegal diversion of these drugs.
Mr. Sloman commended the investigative efforts of the FDA's Office of Criminal Investigations. The case was prosecuted by Assistant U.S. Attorney Jose A. Bonau of the Economic and Environmental Crimes Section, and Special Assistant U.S. Attorney Michael Varrone, a trial attorney with the FDA's Office of Chief Counsel.
A copy of this press release may be found on the website of the United States Attorney's Office for the Southern District of Florida at http://www.usdoj.gov/usao/fls. Related court documents and information may be found on the website of the District Court for the Southern District of Florida at http://www.flsd.uscourts.gov or on http://pacer.flsd.uscourts.gov.