A Joint Project by National Association of Boards of Pharmacy, National Association of Drug Diversion Investigators, and the Partnership For Safe Medicines. This Article was Originally Posted to opioidlibrary.org.
EXECUTIVE SUMMARY
For less than $500, an individual with ill intent can purchase a pill press and a counterfeit pill mold that allows them to turn cheap, readily available, unregulated ingredients into a six-figure profit. Criminals rely upon these pill presses to create dangerous counterfeit medications with toxic substances such as cheaply imported Fentanyl. Their deadly home-made products have reached 46 states in the United States. Of grave concern is the significant lack of manufacturing control utilized in the making of these counterfeit products. The inexperience of these “garage manufacturers” has killed unsuspecting Americans in 30 states.
Counterfeit medications that can kill someone with a single pill are a reality that is increasing at an alarming rate. This is a critical health issue that all three of our organizations are urgently striving to stay on top of.How do these criminals get their hands on pill presses? How are they evading customs inspections? Is possession of these presses illegal and if so, why are more people not charged with it?Recently, the National Association of Boards of Pharmacy, National Association of Drug Diversion Investigators and The Partnership for Safe Medicines joined together to research the extent of the pill press challenge for law enforcement and other first-responders. Key findings include:
- Pill presses are broadly available for sale on the Internet and virtually untracked. These devices are successfully smuggled through customs because the enormous volume of packages makes compliance challenging. Data from Customs and Border Protection (CBP) shows pill press seizures at International Mail Facilities are increasing every year, growing 19 fold from 2011 to 2017.
- The broad availability and sale of pill presses allow novice criminals to make millions of doses of nearly perfect-looking counterfeits that can have deadly consequences.
- Possession of a pill press, while not well regulated, is at most a violation of a Drug Enforcement Administration (DEA) registration requirement carrying no jail time. It only becomes a crime once you add a counterfeit pill mold. However, the prosecution of individuals for possession of a pill press with a counterfeit pill mold is also a rare occurrence and does not carry a sentence high enough to be a deterrent.
- Disrupting the availability of pill presses will be a challenging process. Our research suggests that increasing criminal penalties for the possession or non-registration of a pill press alone is not likely to provide a sufficient deterrent because it relies on a change in charging behavior by prosecutors. Note: Some law enforcement interviewed suggested adding a sentencing enhancement that increases penalties for committing a drug-related crime with a pill press and suggested exploring serialization or registration as a technique to increase the frequency of indictments for illegal possession and manufacturing operations.
METHODOLOGY
To develop this study, staff from all three of our organizations conducted many hours of interviews, studied dozens of prosecutions, and reviewed interviews with many families of victims killed by illegally pressed pills. The National Association of Boards of Pharmacy (NABP), the National Association of Drug Diversion Investigators (NADDI), and The Partnership for Safe Medicines (PSM) each bring complementary expertise in patient safety, law enforcement, and regulatory issues related to the secure pharmaceutical supply chain. The goal is to help understand why America has seen a sudden increase in domestic counterfeit production, its impact on patient safety and law enforcement, and what is required to address the problem.
INTRODUCTION TO THE PROBLEM
We are currently living through a public health emergency of unprecedented proportions: the opioid crisis. A factor that has made this crisis worse is how cheap and accessible tableting machines (often called pill presses) and counterfeit pill molds are a readily available tool to drug traffickers and organized criminal organizations. According to a 2016 Drug Enforcement Administration (DEA) brief, a small investment of $1,000 for a pill press and a pill mold, and a few thousand more for materials, including illicitly imported Fentanyl and binding agents, could yield between $5 to $20 million in salable counterfeit opioid pills. Desk-top pill presses can produce hundreds of pills per hour while easily fitting inside the trunk of a car. The demand and supply for these counterfeit pills have increased rapidly due to a multitude of varying factors. As regulators and policymakers focus on the problem of opioid over-prescribing by implementing important regulations such as prescription limits and production quota reductions, the street price of genuine diverted opioids increases.
In addition, illegal websites, many of them posing as Canadian pharmacies and/or operating on the increasingly accessible dark web have proliferated, and peddle an ever-increasing supply of counterfeit opioids to unsuspected patients. Pill presses provide an even faster and easier way to supply the increased demand. Today, pill presses, pill molds, and the ingredients to make counterfeit pills are illegally smuggled into the United States through trafficking networks, commercial cargo, and small packages with ease.
The overall number of products being shipped in small packages creates a volume so large that many things, including pill presses and molds, are easily concealed. Since Fentanyl is very potent, importing just a kilogram of illicit Fentanyl can help create a multi-million dollar operation. The pill presses themselves hide among the even larger amount of non-medical products, machine parts, industrial parts, and legitimate merchandise. Pill presses are such a poorly-recognized item that sellers can merely break them into three parts to completely obscure their nature.© March 2019 NABP, NADDI, and PSM.
Once illegal pill presses arrive in the United States, the “bootleg” product created can wreak havoc across an entire city in a single weekend. United States law enforcement has seized pill presses capable of producing thousands of counterfeits pills per hour. A single, poorly-made counterfeit containing one extra milligram of Fentanyl is deadly. As PSM’s research shows, fake pill makers both in the United States and outside the United States frequently add toxic levels of Fentanyl to counterfeit pills. More than half of the states in the United States have seen deaths due to these counterfeits containing lethal doses of synthetic opioids, especially Fentanyl.
While people struggling with substance use disorder are at the highest risk of being exposed to these dangerous counterfeits, the increased presence of deadly Fentanyl-laced counterfeits in America has seeped into every community. As these pills circulate, they find their way into the medicine cabinets of people unaware of the existence and potency of these “knockoff ” products. These “knockoffs ” are finding their way into the hands of United States residents and killing them. The existence of a counterfeit pill endangers all Americans, not just the purchaser.
HOW THESE PILLS ENTER THE MARKET
The declaration said the package contained a “hole puncher,” but upon examination, CBP concluded it was a pill press. CBP queried the DEA because it is illegal to import pill presses without prior permission from the agency.
The DEA Coordinator alerted field agents working on a case in the Long Beach, California area about the shipment and its intended destination. Multiple teams around the country were already working on investigations related to Subject Gary Resnik and his ring of drug dealers. The DEA obtained a warrant to put a GPS tracker on the pill press, and in April it was released to ship to Resnik and followed by law enforcement.It’s important to recognize when the interdiction process works. In this case, CBP caught the illegal pill press despite attempts to mislabel it to evade detection. Not only was it found, but it became a direct conduit and useful tool in uncovering a ring of counterfeiters and preventing the potential poisoning deaths of countless Americans. This is the type of story we heard over and over again as we talked to law enforcement; criminal conspiracies to make counterfeits require specific materials, and those materials are the threads you can follow to discover the crime and eradicate a criminal organization.
Based upon this data and other information gleaned during the investigation, the DEA agents working the case raided three locations used by the gang and seized six pill presses, presumably including the one shipped to them that was being monitored by law enforcement. While this case clearly outlines a success and is a great example of how the process is supposed to work, a few important lessons can be drawn from this example:
- Discovery of an illegal pill press’s importation is often used by law enforcement to locate illegal production sites, to uncover a counterfeiting ring, or to provide probable cause for search warrants and further investigation.
- This case study shows how well the interdiction and investigation teams can work, but also exemplifies how the criminal organization had already gotten their hands on five other pill presses that evaded interdiction.Seizures of pill presses are up 19-fold since 2011. In Tennessee alone, law enforcement seized 12 pill presses in 2017.
On the morning of September 18, 2017, while his parents were sleeping, ten-month-old Leo Holtz put a pretty colored pill that had fallen out of his father’s pocket into his mouth. Around 8:25 am his parents woke and found their baby blue and unresponsive. They called 9-1-1, but Leo could not be revived and was declared dead at Rady Children’s Hospital. According to The San Diego Union-Tribune, investigators believe Leo’s father, Colin, bought the pills from Melissa Scanlan, who sourced her counterfeit Oxycodone pills from a drug cartel in Mexico. How-ever, even if the counterfeit Fentanyl pills came from someone else, nothing will ever change the fact that ten-month-old Leo Holz’s life was cut short because of a counterfeit Oxycodone pill made with Fentanyl.
FEDERAL LAWS AND REGULATIONS
Possession of a pill press is not illegal. Buying or selling requires notification to the DEA, but there are no known penalties failing to do so. Possession of a counterfeit pill mold with or without a pill press violates 21 United States Code, § 333, with a criminal penalty of up to one year in jail and a possible fine of $1,000. If the perpetrator intended to defraud or mislead others regarding pill manufacturing the penalty can be up to three years in prison and a fine of $10,000. Actual use of a counterfeit pill press or pill mold in commerce violates 21 United States Code, § 333, and carries a penalty of up to one year in prison and a possible fine of $1,000. Again, if the perpetrator intended to defraud or mislead others regarding the authenticity of the pill the penalty can be up to three years and a possible fine of up to $10,000.
Additionally, buying, selling, reselling, giving, importing, and exporting of pill presses is regulated by DEA. Any time a change of ownership occurs for one of these machines, the DEA requires you to file an electronic report. Importation requires this notification to be made in advance. Domestic transactions require that this notification is submitted within 15 days of the transaction. Domestic transactions also require additional verbal notification to the local DEA office or Special Agent in Charge. The electronic requirement for all transactions including domestic was added in 2017 and is outlined in this helpful presentation from the DEA’s Diversion Control Department.
STATE LAWS AND REGULATIONS
Many, but not all, states have laws that govern the practice of manufacturing prescription medications. These statutes often mirror the Federal Food, Drug, and Cosmetic Act. Illegally owning a pill press with a mold to produce counterfeit pills is a criminal violation of such state laws. It’s important to note the distinction. The possession of a mold used to make copies of a trademarked pill (with the imprint of a trademarked logo) is an illegal act under state law. Only a handful of states regulate the pill press itself. Two of these states are Texas and Florida.
Discovery of a pill press may indicate that someone is engaging in the crime of counterfeit medicine manufacturing. Following the pill press to its destination can lead investigators to members of a criminal conspiracy that they might not have known about. It can also provide reasonable cause needed to obtain a search warrant. Dan Zsido, a veteran law enforcement officer from Florida and the National Training and Education Director for NADDI, explained that there is no point bringing a charge that will be dropped. He said, “Loading up a case with charges consumes valuable, limited, court resources with charges that are just going to be dropped or merged into the more major indictment anyway. This is how narcotics prosecutions have worked for years: if you get charged with trafficking, nobody will take the time to charge you with drug paraphernalia.”
Advocates who study medicine safety detest the broadly dispersed, cottage industry of drug counterfeiters. As with the fear of small meth labs percolating throughout the country, they are concerned that hundreds of criminals are capable of producing millions of doses of perfect-looking but deadly fake medicines. It is a public health and public safety concern.Even if you could make Fentanyl in the United States disappear tomorrow, this manufacturing capacity would still exist. Criminals could turn to other substances to use as the active ingredient in their counterfeit medicines. Unfortunately, drug traffickers adapt to the “drug of the day,” so merely removing a specific controlled substance does not minimize the threat of drug activity; it’s a social behavior issue.
IN CONCLUSION
Today the volume of medical products coming across the border is enormous. FDA Com-missioner Scott Gottlieb, M.D. reported in March 2018 that less than 1% of all medical products coming into the country through International Mail Facilities are inspected. Counterfeit medicines are already extremely difficult to detect. If we legalize drug importation, it will be the same as tripling the size of that haystack (or worse). Finding the Fentanyl-type substances used to make these counterfeits products domestically with unregulated pill presses will be even more difficult and will create an even higher risk of harm to human life.
Law enforcement resources are currently stretched thin stemming the tide of synthetic opioids that are flooding our country. Many of them are presently chasing counterfeit opioids that are flooding our streets, as well as, responding to the overwhelming increases in daily overdoses. If we flood the country with suspect medications through drug importation, our first-responders’ workload would significantly increase because of the increased suspect drug supply and the resulting fallout.
The Accidental Apologist 