From The Tribune staff reports
BIRMINGHAM — A 28-count indictment filed this week in U.S. District Court charges a Hoover man with conspiracy and other fraud charges related to his purchase, manufacture, and distribution of drug products that had never been reviewed or approved by the FDA, but that he claimed were effective cancer treatments.
Patrick Charles Bishop, 54, is charged with conspiracy, fraudulently introducing adulterated drugs into interstate commerce, and fraudulently introducing misbranded drugs into interstate commerce. The Hoover man is also charged with fraudulently obtaining pre-retail medical products, creating false documentation for those products, and knowingly possessing and trafficking in pre-retail medical products that he obtained by fraud.
The charges in the indictment center on Bishop’s purchase, manufacture, labeling, marketing, sale, and distribution of drug products purportedly containing a peptide called PNC-27. PNC-27 has not been approved by the FDA for use in the United States as a drug to treat any disease, including cancer. Nor has PNC-27 undergone clinical trials in the United States to determine its efficacy, safety, or potential risks or side effects on people.
“The public must have confidence that the products they are receiving are safe and properly labeled,” Northern District of Alabama U.S. Attorney Prim Escalona said. “The U.S. Attorney’s Office will continue to investigate and prosecute those who jeopardize the health and safety of the public.”
“The FDA’s requirements are designed to ensure that patients receive safe and effective medical treatments. Evading the FDA process and distributing unapproved, adulterated, and misbranded drugs to vulnerable Americans will not be tolerated,” said Special Agent in Charge Justin C. Fielder, FDA Office of Criminal Investigations, Miami Field Office. “Today’s announcement serves as a reminder of FDA’s continued focus on protecting the public health of the nation.”
The indictment alleges that Bishop obtained the peptide from a manufacturer based in China. According to the indictment, Bishop repeatedly assured that manufacturer that he would use the peptide solely for laboratory research purposes.
According to the indictment, Bishop and others marketed the PNC-27 drug products to alternative-medicine doctors and cancer patients as an effective treatment for cancer. Bishop sold PNC-27 drug products to clinics in Mexico and to patients in the United States.
The indictment alleges that Bishop and others took steps to conceal these activities from the FDA and others. Bishop used the business name Best Peptide Supply, LLC, to buy PNC-27 from GL Biochem, and he used the business name Immuno Cellular Restoration Program, Inc., to sell PNC-27 products to others.
The FDA investigated the case, which Assistant U.S. Attorney J.B. Ward is prosecuting.