October 2, 2023: After deaths overseas, the FDA is working to protect Americans from toxic cough syrup.
This week: USFDA is cracking down on lax safety testing of raw drug ingredients. Major players in HIV drug and cough syrup counterfeiting schemes pleaded guilty in federal court. Counterfeit Avastin in Pakistan blinded over 70 retinopathy patients. CBP at JFK Airport intercepted fourteen pairs of pill press dies. News about illicit pill presses in five states.
Major Stories
The FDA reprimanded 28 companies for lax safety testing of drug ingredients. The second “kingpin” in a HIV drug counterfeiting scheme pleaded guilty.
The U.S. Food and Drug Administration (FDA) is increasing its scrutiny of the raw materials that go into over-the-counter syrups after the recent deaths of hundreds of children in Cameroon, Gambia, India, Indonesia and Uzbekistan from contaminated cough syrup. This year, FDA reprimanded 28 companies for failing to demonstrate adequate testing of raw ingredients for the toxins.
Armando Herrera of Miami, Florida pleaded guilty to distributing at least $16.7 million in adulterated HIV drugs to wholesale pharmaceutical suppliers, disguising them with forged documentation and shell companies. The fake medicines made their way to licensed pharmacies and patients across the country. Herrara is one of two “kingpin” defendants Gilead Sciences is suing for leading a sprawling ring of drug sellers and distributors that allegedly sold over 85,000 counterfeit bottles of HIV medicine to U.S. pharmacies. The other kingpin, Lazaro Hernandez, received a 15-year prison sentence in June 2023.
Watch PSM's April 2023 video about pediatric deaths from tainted cough syrup.
Black market sales of the newest generation of diabetes and weight loss treatments are proliferating. Washington Post reporters investigating black market sales of Ozempic, Wegovy and Mounjaro found more than two dozen websites selling what they claimed was semaglutide or semaglutide sodium, a related drug that the FDA has not approved. Online scammers claiming to sell Wegovy cost a Kentucky woman more than $1,000 without delivering any product to her. In the meantime, drugmaker Eli Lilly sued U.S. medical spas, wellness centers and compounding pharmacies for selling unregulated versions of tirzepatide, the active ingredient in its diabetes drug Mounjaro, and both the Italian Medicines Agency and the Fight the Fakes Alliance warned patients that unauthorized versions of these products could endanger their health.
International News
Over 70 Pakistani patients were blinded after receiving counterfeit Avastin injections. Health Canada is asking healthcare workers to warn patients about unlicensed online drug sellers.
Authorities in Pakistan reported that more than 70 Punjabi residents with diabetes lost their vision after a private hospital in Lahore treated their retinopathy with counterfeit Avastin made by an unregistered company.
Health Canada’s September 2023 Health Product InfoWatch educated healthcare professionals about the risks unlicensed online pharmacies pose to Canadians and linked to the agency's platform to report the illegal marketing of drugs and devices.
Pakistan's Drugs Regulatory Authority published this image of an unregistered version of Avastin in a September 2023 recall notice.
Domestic News
Iowa’s AG is suing two businesses over fake stem cell treatments. NABP debuted consumer protection content about illegal online sales of prescription drugs. A cough syrup counterfeiter was sentenced. CBP in New York seized 14 sets of pill dies being shipped from China. News involving illicit pill presses in five states.
A Washington state naturopath who's been convicted 3 times for selling fake cures is going to prison again. Watch.
Iowa’s Attorney General filed suit against two businesses and their owners for allegedly selling more than 250 residents fraudulent stem cell therapy and administering stem cell treatments in patients’ homes. In 2019, the FDA urged Americans not to “believe the hype” about stem cell treatments, warning that unproven treatments could fail to work or cause reactions at the injection site, the growth of tumors or other injuries.
In September the Ninth Circuit Court rejected Port Angeles, Washington naturopath Richard Marschall appeal of an eight-month federal prison sentence for selling fraudulent COVID-19 treatments. A legal analysis noted that Marshall’s previous conviction for selling misbranded drugs allowed a felony conviction for this crime even if prosecutors did not demonstrate the defendant’s “intent to defraud or mislead.”
A study from the Center for Countering Digital Hate examined content promoting performance-enhancing drugs to teenagers and young adults on TikTok, and called for the platform to enforce its ban on the promotion of drugs.
The Environmental Protection Agency is suing eBay for unlawfully selling and distributing hundreds of thousands of products, including a one that falsely claimed to offer protection against COVID-19.
The National Association of Boards of Pharmacy’s newly published Tactics Criminals Use to Sell Drugs Online explains how the more than 40,000 illegal pharmacies active online threaten the safety of unsuspecting patients.
Customs and Border Protection (CBP) officers at John F. Kennedy International Airport seized 14 pill press die sets in five separate shipments from China. Drug counterfeiters use this equipment to make counterfeit pharmaceutical pills, often made with fentanyl and other dangerous drugs.
Byron A. Marshall, a Houston, Texas man received a 25-year prison sentence for his leading role in a drug trafficking organization that manufactured and sold more than 500,000 pints of counterfeit cough syrup to buyers in 12 states. Ten co-conspirators, including pharmaceutical executive Adam P. Runsdorf, already pleaded guilty. Three await sentencing.
A Cerritos, California resident who was caught with 450 pounds of suspected narcotics, pill press machines, and illegal firearms in November 2022 has agreed to plead guilty in federal court. 37-year-old Christopher Hampton was part of a ring that made and sold more than 20,000 multicolored, fake oxycodone pills made with fentanyl on the dark web.
Examples from 14 sets of pill dies CBP seized at JFK Airport in September 2023. (Courtesy CBP)
Brandon Adams of Sullivan, Missouri also pleaded guilty to charges related to the sale of fake medicine. Adams was one of seven people who made and sold counterfeit benzodiazepine pills on the dark web under the name “BenzoBoys” between 2019 and 2021. Law enforcement seized $630,000 in cash, $330,000 in Bitcoin, a pill press, tens of thousands of misbranded pills and other drug paraphernalia when they searched his apartment and lake house in May 2021.
Pill press seizures also happened in Mandeville, Louisiana and Charlotte, North Carolina and a man in Wenatchee, Washington received a five-year sentence for making MDMA and counterfeit pharmaceutical pills.