Updated: Tuesday, May 9, 2017, 3:01 AM
Over the past five years, teams representing the Department of Justice and the Food and Drug Administration Office of Criminal Investigations have prosecuted multiple cases against unlicensed wholesalers selling large quantities of non-FDA-approved medications to U.S. doctors.
The largest Canadian online pharmacy and related entities were indicted for selling $78 million worth of unapproved and counterfeit medicines that ultimately were administered to cancer patients. Agents lab-tested these medications and found them to be devoid of active pharmaceutical ingredients. In other cases, testing of seized drug samples revealed toxic additives.
As Congress struggles to gain consensus for an overarching solution to rising health-care costs, some policymakers have introduced piecemeal legislative solutions to permit drug wholesalers, licensed U.S. pharmacies, and individuals to import prescription drugs direct from Canada and eventually from Europe and other parts of the world. The reality of these proposals is the elimination of safeguards that currently protect our prescription-drug supply. Candidly speaking, this move will vastly increase the incentive for criminal organizations to counterfeit drugs. The result would be that U.S. and international law enforcement would be overwhelmed as they lose a major tool in fighting the proliferation of counterfeit drugs.
In the fight against terrorism, we have assumed the additional costs of heightened security at airports to ensure that our air travel is safe. Opening up the U.S. prescription-drug supply is akin to eliminating any of the familiar security checkpoints we have in place to safeguard our air travel. Current proposals would take away one of the most effective means to protect our prescription-drug supply and leave U.S. and international law enforcement vulnerable to criminal organizations seeking to infiltrate our prescription-drug supply with fake, adulterated, and counterfeit drugs. We rarely think about taking down lines of defense in our fight against terrorism, so why would we permit it within our health-care system?
Consider recent cases in which FDA special agents have seized the customer lists of unapproved distributors as a part of their investigations. The lists have revealed names of more than 2,000 doctors and medical clinics in 49 states, Washington, D.C, Puerto Rico, and the U.S. Virgin Islands doing business with four criminal rings. These cases could be prosecuted because of our closed, FDA-supervised drug distribution system that requires all manufacturers, distributors, and sellers to be licensed and subject to oversight. The importation proposals before Congress take away these critical protections. Each case required a multi-year, multi-agency collaborative investigation.
At the same time, the proposals also make it easier for drug cartels, which are not likely to forgo the opportunity to expand their business at the expense of the nation’s health and safety, to distribute counterfeit drugs throughout the United States. The increased volume alone would make it impossible for the FDA, U.S. Customs and Border Protection, and the Drug Enforcement Agency to keep up with vastly expanding criminal operations. The United States is in the midst of an opioid crisis exacerbated by the introduction of fentanyl, a super-potent synthetic opioid that is easier to ship and with higher profit margins than other illicit drugs. As one DEA special agent stated, “Criminals are putting fentanyl into fake pills and passing them off as legitimate prescription medications.”
Finally, the sheer strain that legalized drug importation would have on law enforcement agencies cannot go unappreciated. We’ve all come to realize the range of criminal threats that exist both at home and abroad. However, we’ve also been faced with resource and budget challenges that force us to do more with less. Rolling the dice on a drug importation law would undoubtedly take resources away from other important law enforcement efforts, at a time when we’re living in a perpetual state of heightened alert.
Allowing citizens to purchase medicine direct from foreign countries will mean more risk to consumers from counterfeit drugs, more opportunity for criminal activity in the marketplace, and more stresses placed on overstressed law enforcement efforts to combat this problem. The belief that U.S. consumers can gain access to safe and low-cost medicines from Canadian and European drug markets without an offsetting cost to consumer confidence and law enforcement is not realistic. Quite the contrary, drug counterfeiting is a global threat that we’re inviting upon ourselves if Congress allows this idea to move forward.
Louis J. Freeh is former director of the FBI and a former federal judge. He is currently chairman of Freeh Group International Solutions. Bescript@freehgroup.com
Read full story: Cost of drug importation could unfairly shift to law enforcement