Inspections, Compliance, Enforcement, and Criminal Investigations
March 25, 2011: Illicit Manufacturers of Pharmaceutical Products Arrested
An Indictment charging Brian Parker and Michelle Pfeiffer with conspiracy to misbrand drugs and impede the lawful functioning of the FDA was unsealed today following the arrests of the defendants, announced United States Attorney Zane David Memeger. Parker and Pfeiffer are also charged with fraud related to the misbranding of drugs and failure to register a drug manufacturing facility.
According to the indictment, the defendants advertised on internet websites and message boards - whose audience is primarily body builders and athletes - which would discuss the benefits and dosing of different performance-enhancing drugs. Defendant Parker allegedly offered prescription drugs for sale without asking for a prescription from a licensed medical practitioner, including Cialis, Viagra and a drug that was named “Superman,” which defendant Parker identified as a combination of 20 mg of Cialis and 40 mg of Viagra. Other drugs which the defendants allegedly offered for sale were “GHRP-6" or “Growth Hormone Releasing Agent Protein,” and “IGF” or “Insulin Growth Factor,” both of which were peptide or protein-based drugs popular with body builders for increasing strength and muscle mass but which were never approved by the FDA for any indication.
The indictment alleges that, although defendant Parker advertised brand name prescription drugs such as Cialis and Viagra, he instead provided imitations of those drugs that he manufactured in the basement of his home, despite that he had never sought approval from FDA to distribute the drugs he manufactured into interstate commerce, and never registered his manufacturing facility with FDA. Defendant Parker allegedly accepted orders for prescription drugs via email using the pseudonym “Dedicated1” and the email address email@example.com. When accepting orders, he allegedly instructed customers to write messages in their drug orders in an attempt to conceal the true nature of the transactions. The defendants would then allegedly manufacture the drugs in their residence by converting bulk active and inactive ingredients into capsules or tablets, creating labels bearing false or misleading information for the misbranded drugs, and would then ship the drugs to customers throughout the United States.
INFORMATION REGARDING THE DEFENDANTS
If convicted the defendants face a maximum possible sentence of 42 years in prison, a $3.75 million fine, three years supervised release, and a $1500 special assessment. The case was investigated by the Food and Drug Administration-Office of Criminal Investigations and the United States Postal Inspection Service. It is being prosecuted by Assistant United States Attorney Joan E. Burnes.