FDA Announces Guilty Plea for Misbranded Human Growth Hormone from China
The Food and Drug Administration states that Medisca, Inc., a New York corporation located in Plattsburgh, New York, and its President, Antonio Dos Santos, age 63, of Montreal, Canada, have pled guilty to a one count misdemeanor of introducing a misbranded drug, specifically somatropin (human growth hormone), into interstate commerce using misleading labeling. Dos Santos faces a maximum term of up to one year in prison, a $100,000 fine, up to 1 year of supervised release to follow any period of incarceration, and an order of restitution. Medisca faces a maximum term of five years probation, a $200,000 fine, and an order of restitution. In addition, Dos Santos and Medisca have agreed to forfeit over $1.7 million, which represents Medisca's gross profits from the unlawful drug sales.
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HGH Imported from China Promoted as Being FDA-Approved due to "National Drug Code Number"
In entering their guilty pleas, Dos Santos and Medisca admitted that from approximately July 2004 through February 2007, Medisca imported from China and distributed to pharmacies throughout the U.S. over 1737 grams of somatropin, also known as human growth hormone (HGH). They each also admitted that from at least as early as March 4, 2005, Medisca provided promotional literature to the pharmacies claiming the somatropin was either an FDA-approved drug or from an FDA-approved facility based on the fact that the Chinese manufacturer of the somatropin had obtained from FDA a National Drug Code number for the product.
But "National Drug Code Number" Does Not Denote FDA Approval
The National Drug Code is a number system FDA utilizes to assign a drug listing number to each drug or class of drugs a manufacturer lists and registers with the FDA. However, FDA's regulations explicitly state that "assignment of a NDC number does not in any way denote approval of the firm or its products," and "[a]ny representation that creates an impression of official approval because of registration or possession of a registration number or NDC number is misleading and constitutes misbranding."