News, Views & Reviews: Importing Injectables
September 2014 | Volume 13 | Issue 9 | Feature | 1156 | Copyright © 2014
Kenneth Beer MD PA and Karen Rothschild JD
No abstract available
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The sub-headline of Dr. Kenneth Beer’s article in the March 2013 issue of The Dermatologist reads: “There are numerous ways to decrease the cost of toxins and fillers, including importing materials from another country and using less expensive materials, but the results achieved with such products may be less than optimal.”1 There is nothing incorrect about this statement; but the possibly harmful repercussions to both patients and practitioners may be significantly greater than outlined in that article. Karen Rothschild, a Regulatory Counsel with the Food and Drug Administration (FDA) in the Center for Drug Evaluation and Research (CDER), has partnered with Dr. Beer to elucidate the scope of the issues such practices raise.
FDA’s Office of Drug Security, Integrity, and Recalls
To help protect patients from the potential harm caused by impure, counterfeit, or otherwise illegally sourced drugs, the FDA has established an office within CDER’s Office of Compliance that is dedicated to promoting the quality, integrity, and security of human drugs for US patients. Due to the global sourcing of drugs and easy availability of products distributed through dubious supply chains, there was a need to establish such an office. The increasingly complex global drug supply chain has increased the risk of patient exposure to substandard drugs and has necessitated that the FDA dedicate more resources to protecting patients from counterfeit, diverted, or intentionally adulterated drugs.
Drugs purchased through the legitimate, regulated supply chain in the US continue to be safe and effective. The US has one of the most secure regulated supply chains in the world. However, when there is an opportunity to increase profit, unscrupulous suppliers, doctors, other practitioners, and corporations may seek to exploit it. And patients may seek out less expensive “alternative” drugs, without considering or understanding the risks that arise from obtaining drugs from unregulated sources. The combination of a global recession, increasing drug prices, and improving manufacturing and printing technologies create sophisticated counterfeiting opportunities that are cheaper and easier for criminals.
Over the past 2 years, FDA has sent informational letters to well over a thousand doctors, to provide information about suppliers working outside of the legitimate pharmaceutical supply chain. Despite these warnings, some doctors have elected to continue purchasing less expensive products through questionable suppliers. Some of these doctors may know that they are buying unregulated products, but many do not. Amongst the recipients of letters have been many cosmetic doctors, medi spas, and medical practices that were known to have purchased or received drugs from unlicensed, foreign, and unsavory suppliers, which FDA has confirmed have sold substandard or counterfeit products. When a product is unapproved or comes from a source outside of the regulated supply chain, no one monitors the quality of manufacture, storage, or the purity of the ingredients. Quite simply, no one is looking.
Possible Harm to Patients
Patients may be harmed by drugs that have not been approved by FDA, as the products have not been determined to be safe or effective, and the companies (or individuals) making the drugs have not had their manufacturing practices or handling procedures inspected by FDA. This means that there is no guarantee, or even a reasonable expectation, that the drugs are of suitable quality and there is no reason to believe that they been proven to be safe and effective pursuant to FDA standards. Drugs imported from foreign or unlicensed suppliers may be from unknown sources, may have unknown ingredients, may be counterfeit, or may not have been manufactured, transported, or stored under proper conditions as required by US law, regulations, and standards. Drugs that have not been reviewed for safety, efficacy, and good manufacturing may be subpotent, superpotent, or have no active ingredient whatsoever. These products may not be even remotely close in composition to what the drug is being advertised as by those trying to sell them. They could lead to poor results, adverse reactions, or worse.
With respect to botulinum toxins in general, and Botox® in particular, the potential for harm to patients is not new. In November 2004, four patients became paralyzed after being injected with potent, unapproved botulinum toxin that a doctor used instead of FDA-approved Botox® Cosmetic. By July 2008, 29 people had been convicted of purposely using an unapproved, cheaper version instead of FDA-approved Botox® Cosmetic. These people injected about 1,000 unknowing patients. Unfortunately, despite publication of their names in several local and national newspapers, many of these practitioners remain in practice. Particularly with a toxin, doctors have long known about the precision required for optimal results and for patient safety. However, because patients trust their medical provider to obtain safe and effective injections, patients should be suspicious about any “deals” or discounts. Patients should also be aware that when doctors start to compete based solely on price, the pressure to dilute the products injected may increase substantially. Dilution of Botox® is the most common reason for patient complaints to doctors that the injections “don’t last” or that “Botox just doesn’t work”.
How Patients are Scammed
Botulinum toxins are now undergoing a new phase of counterfeit that is extremely dangerous. In contrast with the events of 2004 where the doctors knowingly used an unapproved product instead of Botox® on unsuspecting patients, the new danger is primarily driven by patients who demand ever less expensive injections. They come to their doctor offices armed with internet