BIRMINGHAM, Ala. – A twenty-eight-count indictment filed today in U.S. District Court charges a Birmingham 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, announced U.S. Attorney Prim F. Escalona and FDA Office of Criminal Investigations, Miami Field Office Special Agent in Charge Justin C. Fielder.
PATRICK CHARLES BISHOP, 54, is charged with conspiracy, fraudulently introducing adulterated drugs into interstate commerce, and fraudulently introducing misbranded drugs into interstate commerce. Bishop 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 on human beings to determine its efficacy, safety, or potential risks or side effects.
“The public must have confidence that the products they are receiving are safe and properly labeled,” 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 GL Biochem, a manufacturer based in China. He paid the manufacturer more than $600,000 in 2015 and 2016 for peptide product he received. According to the indictment, Bishop repeatedly assured that manufacturer that he would use the peptide solely for laboratory research purposes. In fact, he and others used the peptide to make homemade suppositories in his kitchen in Birmingham, and at a warehouse he rented in Pelham. The facilities were not sterile, and did not comply with current good manufacturing practices. Customers who purchased suppositories from Bishop reported finding pieces of hair in their suppository packs.
According to the indictment, Bishop and others marketed the PNC-27 drug products to alternative-medicine doctors, cancer patients, and others as an effective treatment for cancer. Bishop sold PNC-27 drug products to Hope4Cancer, a holistic cancer treatment center with clinics in Mexico. Bishop would ship the products to a location in California, and Hope4Cancer would use the products to treat patients at its Mexico clinics. Bishop also sold PNC-27 drug products to patients and others in the United States, and shipped those products directly to locations in the United States and elsewhere.
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. He described his distribution of PNC-27 products as part of a research effort, and made false representations to FDA personnel and others to the same effect.
The maximum punishment for conspiracy is five years in prison and a $250,000 fine. The maximum punishment for the adulteration and misbranding charges is three years’ imprisonment for each count and a $250,000 fine. The maximum punishment for each count of pre-retail medical product fraud is fifteen years’ imprisonment and a $250,000 fine.
The FDA investigated the case, which Assistant U.S. Attorney J.B. Ward is prosecuting.
An indictment is merely an allegation and the defendant is presumed innocent until proven guilty beyond a reasonable doubt.