Each year tens of thousands of counterfeit prescription drugs enter the U.S. ranging from sugar pills that fail to deliver any medical benefits, to those containing actual toxins that can cause serious harm, including death. In either case, the consumer becomes the victim and suffers harm to varying degrees. Over the past several decades, through the combined efforts of regulators and private industry watchdogs, such as John Horton's LegitScript, we have a better sense of what works and what doesn't, in the fight against drug counterfeiters.
A relatively new class of drugs called "biologics" is creating formidable challenges for industry regulators. Because biologics include a wide range of living entities such as vaccines, blood, gene therapy, tissue, even recombinant proteins (to name just a few), and are created by biological processes (as distinguished from chemistry), they have added major therapeutic benefits for the treatment of many diseases. They have been shown effective in treating some ailments for which no therapies were available, and others where previously existing therapies were clearly inadequate. As a result, they will inevitably be a target for counterfeiters intent on making outrageous profits at the expense of patient safety. So what can be done to prevent prescription drug counterfeiters from injecting the U.S. market with fake biologics?
First, the FDA is currently considering what is called an "abbreviated pathway" for approving legal knock-offs of biologics (called "biosimilars") that will enable copycat and thus cheaper versions of these life-saving medications to become FDA-approved. It's important to ensure that this process doesn't cut corners: the FDA should hold biosimilars to the same standards of safety as the original biologics. Unlike non-biologic medicines, where a "generic" version is more or less an exact chemical replica, biosimilars can never truly be identical to the original biologic. Hence, the only way to ensure the same level of safety is to require similarly rigorous clinical testing for biosimilars as is required for the original biologics.
Second, be watchful about how counterfeiters operate. Some have been known to insert convincingly real-looking counterfeits into the normal prescription drug supply chain. "Track and trace" technology affords regulators and drug companies the ability to follow a drug's supply chain back to the origin.
Third, empower pharmacists, physicians and patients. When a biosimilar is approved, labels and product names should adequately educate the reader as to whether the drug is the original biologic or a copycat biosimilar. As with any product, it's tempting for copycat manufacturers to want to cash in on the original creator's trademark, suggesting that the products are identical; but when it comes to medicines, it is probably not safe to allow that.
John Horton is President and Founder of LegitScript, and a former aide in the White House Office of National Drug Control Policy (ONDCP). John Horton founded LegitScript with the intent of helping people be sure that they are buying safe and genuine legit script medication on the Internet. LegitScript, is an internet enforcement service group, that has been successfully investigating sites to determine whether or not such sites are in compliance with the law and accepted standards of medical and pharmacy practice ethics.