Birmingham Man Sentenced for Making Unapproved Drug Products
BIRMINGHAM, Ala. – A Birmingham man was sentenced today for his role in making unapproved drug products in his kitchen and warehouse, and then marketing and selling them as a cancer treatment, announced U.S. Attorney Prim F. Escalona and FDA Office of Criminal Investigations, Miami Field Office Special Agent in Charge Justin C. Fielder.
U.S. Senior District Judge Karen O. Bowdre sentenced Patrick Charles Bishop, 54, to 30 months in prison followed by three years’ supervised release for conspiracy to fraudulently introduce adulterated drugs and misbranded drugs into interstate commerce. Judge Bowdre also ordered Bishop to forfeit $900,000 in proceeds from his crimes. Bishop pleaded guilty to the charge in January.
“The defendant posed a dangerous threat to patients who thought they were receiving an approved and effective treatment for cancer,” U.S. Attorney Escalona said. “My office will continue to prosecute those who deceive the public by selling unapproved drug products.”
“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.”
According to the plea agreement, Bishop ran a business that made, marketed, sold, and distributed products purportedly containing a peptide called PNC-27, and purportedly effective in treating cancer. During 2015 and 2016, Bishop received millions of dollars from sales of PNC-27 products.
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. Bishop 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 a Chinese supplier, and a different 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 promoted himself as a research director. Bishop had no formal training or education in medicine or the treatment of diseases.
Bishop repeatedly assured his Chinese supplier that he would use the peptide solely for laboratory research purposes. In reality, he used the peptide to make homemade suppositories in his kitchen in Birmingham, and at a warehouse he rented in Pelham, and then marketed and sold those products as a cancer treatment. The kitchen and warehouse were not sterile and the process of making the suppositories did not comply with current good manufacturing practices.
The FDA’s Office of Criminal Investigation investigated the case, which Assistant U.S. Attorney J.B. Ward is prosecuting.
News article: https://www.justice.gov/usao-ndal/pr/birmingham-man-sentenced-making-unapproved-drug-products