Company Pleads Guilty to Selling Misbranded Drug

Oct 19, 2011   

On October 14, 2011, Medisca, Inc. pled guilty to introducing a misbranded drug into interstate commerce in violation of the federal Food, Drug and Cosmetic Act (FDCA). The Complaint, which was filed on October 14, alleged that Medisca purchased a drug called “Somatropin” from China and then proceeded to distribute the drug to various pharmacies throughout the United States.

The primary issue in the case was that Somatropin, a type of human growth hormone (HGH), was being marketed as having approval from the U.S. Food and Drug Administration (FDA). According to the Complaint, the drug was not FDA approved, rendering the drug’s labeling false and misleading and therefore misbranded under the FDCA. Although it was Medisca’s contention that it possessed a valid National Drug Code (NDC) pursuant to FDA’s rules requiring every manufacturer and/or distributer to register and list all drugs in commercial distribution, the FDA warned that a NDC does not denote a drug approval. Rather, in order for drugs to be properly distributed under the FDCA and accompanying FDA regulations, a New Drug Application (NDA) must be obtained for all new drugs prior to entering interstate commerce.

Additionally, only drugs that possess an NDA may be marketed as “FDA approved.” The Office of Prescription Drug Promotion (OPDP), formerly the Division of Drug Marketing, Advertising, and Communication (DDMAC), is a division within the FDA specifically tasked with overseeing promotional claims and labeling of drugs. OPDP ensures that marketing claims are within FDA regulations and limited to what the FDA has actually approved. Further, because drugs must possess a valid NDA before lawfully being advertised as “FDA approved,” the FDA flatly prohibits other types of products, like over-the-counter (OTC) drugs and medical devices with FDA clearance, from being marketed as approved by the FDA.

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