COUNTERFEITING IS NOT A VICTIMELESS CRIME. In the last 24 hours it has been reported by CNN and others that the iconic music legend, PRINCE, became another victim of counterfeit pharmaceuticals. In bottles marked as Vitamin C and Aspirin pills were found containing the powerful anesthetizing drug, fentanyl. It is reported that fentanyl is fifty times stronger than heroin and one hundred times stronger than morphine in its debilitating effects on the human body. It is legitimately used with terminal cancer patients or as an anesthetic during surgery.
The US Food and Drug Administration (“USDA”) refers to counterfeit prescription drugs as: “fake, contaminated, ineffective, or otherwise unsafe ingredients; drugs that have not been tested by the FDA for safety and efficacy; drugs that don’t carry the correct amount of active ingredients or; drugs that carry harmful ingredients. How far are counterfeiters willing to go to victimize the pill-popping citizens of the United States? These organized efforts are part of a criminal secondary market that has produced incredible profits because legitimate prescription drugs are often too expensive for the average American. Part of the problem rests with big pharma itself which over the past several decades has inundated media with consumer advertising for prescription drugs from Viagra to Avastin.
The problems arising from counterfeit prescription drugs has been documented since at least as early as the 1980’s.Two well-publicized incidents attracted headlines. First, counterfeit Ovulen-21 birth control pills were being sold to American women. These pills had originated from Panama and were found to be ineffective. Second was the distribution of counterfeit Ceclor, an antibiotic, and Naprosyn, a pain reliever, by a sophisticated pharmaceutical educated resident of Iran. In line with these developments Congress passed the 1987 Prescription Drug Marketing Act or PDMA. The PDMA required states to license prescription drug wholesalers; put in place a requirement for non-authorized distributors to show the “pedigree” of the drug; and third, imposed requirements for the distribution and accountability of drug samples. Under pressure from various interest groups Congress and the FDA delayed imposing the “pedigree” requirements for decades until technology was developed in the form of Radio Frequency Devices (“RFD”) which allows manufacturers to track and trace each of the prescription drug products. Unfortunately, track and trace technology does not necessarily get used during the supply chain process of base chemical ingredients which are often sourced from third-world or lesser developed nations with lax quality control oversight.
In 2015, Congress enacted the Drug Supply Chain Security Act, which required all health care providers to provide prescription drugs to patients which are purchased from authorized licensed trading partners. However, as evidenced by a July 22nd release from the FDA; see “Counterfeit Prescription Pills Containing Fentanyls: A Global Threat” at www.DEA.gov. When it comes to fentanyl, the danger appears to be increasing. Chinese suppliers of legitimate ingredients are at the same time manufacturing large amounts of uninspected synthetic ingredients like fentanyl. The report indicates that counterfeiters can transform as little as one kilogram of fentanyl powder costing a few thousand dollars into hundreds of thousands of counterfeit pills reaping millions of dollars in profits.
Trafficking in counterfeit pharmaceuticals is subject to both criminal and civil penalties. So when consumers think that it’s fun to buy knock-offs they ought to think about the fact that they themselves could be a victim of this dangerous game. The death of the icon of the “Minneapolis Sound” in his Paisley Park home will effect America’s culture for decades to come.
To learn more about anti-counterfeiting, contact Anthony Keats, the co-chair of the Copyright & Trademark Practice at Stubbs Alderton & Markiles, LLP. You can reach him at email@example.com or (310) 746-9802.