Crime and Policy III: Counterfeit medicines in 2021
Watch the webinar (above) or review the presentation slides (at right).
Presentation slides 3-13
State legislative updates
As of June 2021, 17 states have introduced 25 bills relating to foreign drug importation. Two of these bills passed:
- North Dakota's SB2212 authorizes a study of Canadian drug importation.
- Colorado's S123 allows importation from any country in the world with U.S. FDA approval.
Many other states will end their sessions with bills failing to move forward.
Drug-related / drug-induced homicide
California SB 350, which was named for Temecula resident Alexandra Capelouto did not pass this year, but California is among several states have made efforts to hold drug dealers accountable for the death of individuals killed by products they sold.
Riverside County DA Mike Hestrin filed second degree murder charges against a man who sold counterfeit pills that allegedly killed 18-year-old Angel Vazquez and nearly killed a 16-year-old.
Yolo County DA Jeff Reisig is formally warning every convicted drug dealer that they could face future homicide charges.
Oklahoma law categorizes the death of a person as a result of the illegal distribution of a controlled dangerous substance or synthetic controlled substance as first degree murder, regardless of intent.
As of June 2020, the state had charged five alleged drug traffickers with murder in connection with nine counterfeit pill deaths.
Presentation slides 14-23
Criminalizing Abused Substance Templates Act
The penalty for owning an illegal pill press is not enough to deter criminals. H.R. 4510 would remedy that by escalating penalties for controlled-substance related crimes if the criminal has a pill press mold in their possession.
H.R. 5663 passed into law in January. The bill amended the federal Food, Drug and Cosmetic Act to add “counterfeit device” to the list of items that can be refused entry into the United States.
Online marketplaces, social media and search engines should report illegal drug content
Sale of counterfeit medicines through social media and online platforms is not a new problem and it continues to be deadly, and social media companies are protected from being held responsible for this activity. We support creating a duty to report counterfeit drug selling activity for online platforms.
Permanent scheduling of fentanyl analogues
Many fentanyl analogues are only controlled substances because of temporary actions that must be extended by congress. If those actions lapse, prosecutors will not be able to use controlled substance charged to jail criminals selling deadly drugs.
PSM opposes foreign drug importation
PSM, PhRMA, and the Council for Affordable Health Coverage have filed suit against HHS to overturn the federal rules governing state importation programs finalized by the Trump Administration in September 2020.
Read PSM's most recent importation update: Canadian Drug Importation – What’s The State Of The Issue In June 2021?
Trends in Drug Counterfeiting
Presentation slides 26-33
Fake pills with fentanyl
(or other ingredients)
Fentanyl pills have been reported in all 50 states, but counterfeit pills contain more than just fentanyl.
Fake Adderall with meth
Fake medical devices / products
Officials in 92 countries participated in this year's Operation Pangea, seizing nine million fake and unapproved medical products—more than half of which were fake or unauthorized COVID-19 testing kits. (Watch our video about this year's Operation Pangea.)
For more about the global fake meds trade:
- "Thousands of fake online pharmacies shut down in INTERPOL operation," Interpol, June 8, 2021
- Trade in Counterfeit Pharmaceutical Products , OECD and EUIPO, 2020
Global counterfeiting boom
This year has seen some noteworthy global counterfeit incidents, including fake:
- COVID vaccines in China, India, Mexico, Poland, and Africa
- Remdesivir in India and Mexico
- Hematology and oncology drugs in Hong Kong, and
- A counterfeiting ring that sold fake medicines to 14 Indian states over the last 18 months.
The bustling market in fake and substandard PPE also continues. CBP seized more than 20 million counterfeit medical masks in just the first three months of 2021, and the FDA placed all alcohol-based hand sanitizers from Mexico on an import alert in January because of widespread methanol contamination.
Presentation slides 34-41
U.S. v Stefen Knoche
April 2021: Stefen Knoche of Lebanon, Pennsylvania received a 70-month federal prison sentence for repackaging and reshipping for foreign counterfeiters who were selling Viagra, Aurogra, Xanax, Levitra, Cialis, Valium, and others.. He was also ordered to pay $3,648,911.18 in restitution.
U.S. v Vincent Decaro
June 2021: Vincent Decaro of Stamford, Connecticut pleaded guilty to a charge related to making fake oxycodone pills using with fentanyl analogues. Law enforcement searched Decaro’s home while he was in Europe and seized fentanyl pills and powder, three pill presses, and other drug paraphernalia. Albanian State Police arrested Decaro and an associate while they were trying to cross the border into Kosovo in September 2018.
U.S. v Maksym Nienadov and Volodymyr Nikolaienko
Nienadov and Nikolaienko are Ukrainian nationals who pleaded guilty to conspiring to smuggle and distribute counterfeit cancer and hepatitis drugs into the U.S in July 2020. In fact, they sold the drugs globally via a messaging app called WhatsApp. They were arrested in April 18, 2019 after undercover U.S. authorities lured them to the U.S. with a business meeting. (The U.S. has no extradition treaty with Ukraine.).
In March 2021, they received sentences of 71 and 33 months, respectively.
U.S. v Bruce Holder et al
April 2021: A federal jury convicted Bruce Holder of Grand Junction, Colorado of distributing fentanyl and counterfeit substances that killed a Carbondale man in 2017. Holder sold tens of thousands of counterfeit pills made with fentanyl, including the half of a pill that killed Ashley Romero in June 2018.
Teva-Oxycocet counterfeits in Ontario
In February 2021, just over the Canadian border in Niagara Falls, the Niagara Regional Police Service made the second bust of meticulously counterfeited Oxycocet in Ontario in a year. They seized 400lbs of an unknown powder, an industrial pill press, and 20,000 fentanyl pills in realistic-looking Teva-Oxycocet bottles.
The seizure closely resembles another Ontario seizure from June 2020.
Doctors are still importing their own medicines
Over the past twelve years there have been incidents of black market medicine in forty eight states, with convictions in seventeen states. Many patients have no idea their physician was warned by the FDA.
Four physicians have been in the news for illegally importing medicine so far this year.
- Benjamin Franklin Sanford, Jr. of Starkville, Mississippi, will serve probation and pay more than half a million dollars in fines, forfeitures and restitution for treating his patients with illegally imported, non-FDA approved osteoporosis drugs between 2013 and 2018.
- San Fernando Valley, California oncologists Stanley Rossman and Mark Goldstein pleaded guilty to purchasing more than $1 million in illegally imported, non-FDA approved cancer drugs from Montana Healthcare between 2008 and 2011. Theirs was among 135 medical practices nationwide that the FDA warned to stop buying cancer treatments from Quality Special Products in 2012.
- In April 2021, a federal grand jury indicted Lindsay Marie Clark, a San Francisco Bay Area California physician, for allegedly defrauding and endangering her patients by treating them with cosmetic injectables she purchased online from unlicensed foreign sellers.
- Indictment, U.S. v Clark, Northern District of California, April 2021
Other interesting cases
Johnny Stine, of Seattle, Washington, who first came to public attention in March 2020 when he tried to sell his own untested “COVID-19 vaccine,” was arrested and charged on January 21, 2021 after one of the people he injected was hospitalized with the coronavirus.
Tymalk Quane Love, an Oklahoma inmate, pleaded guilty in June 2021 to facilitating the sale of methamphetamine, heroin, and fentanyl pills from prison between January 2018 and February 2019.
74-year-old Lawrenceville, Georgia resident George Kuiper pleaded guilty in federal court to operating an illegal internet pharmacy and received a sentence of three years probation in June 2021. Between 2006 and 2020, he ran websites that sold unapproved drugs and controlled substances that he had smuggled from foreign countries.
In April 2021, federal courts charged four Connecticut residents with the distribution of oxycodone pills, counterfeit pills containing fentanyl, and other drugs in the Hartford area. Court documents alleged that the pills were sold out of neighborhood grocery stores in New Britain and Hartford.
After five years as a fugitive, Nitica Lee pleaded guilty in St. Louis County, Missouri to involuntary manslaughter in for the death of 22-year-old Daysha Phillips, who died after Lee injected her with black market silicone in July 2015. She received a five-year prison sentence.