Counterfeit Medicine: Can a Biotech Help Solve the Problem?

Medikamente, Pillen, Fälschung

(DGIwire) — The number of “rogue” wholesale distributors selling fake or unapproved prescription drugs is growing, so people in the healthcare industry—including doctors, hospital drug purchasers and drugstore managers—need to be vigilant when purchasing medicines. This has become such a widespread issue that the U.S. Food and Drug Administration (FDA) recently launched a campaign to help physicians and healthcare institutions become more aware of the problem so that they don’t accidentally distribute these drugs to patients or customers by mistake.

Launched online in 2014, the FDA’s “Know Your Source” website provides doctors and other stakeholders tips on identifying counterfeit drugs, warns them against buying drugs from questionable sources, and outfits healthcare providers with a tool to help verify their wholesale drug distributor’s license. The FDA has also faxed a number of flyers to doctors’ offices nationwide, urging healthcare professionals to:

  • Be wary of sales and deals that are too good to be true.
  • Look out for unfamiliar packaging, safety information, doses or labels not in English.
  • Buy from a wholesaler licensed in their state.
  • Pay close attention to patient feedback on new side effects or lack of therapeutic effects.

These warnings come on the heels of a number of high-profile counterfeit drug incidents in the last several years. In February 2012, the FDA sent out a warning for the cancer drug Avastin. The drug circulating was potentially dangerous and did not contain the active ingredient, bevacizumab. In May 2012, the agency issued a warning that there were fake Adderall pills in circulation that didn’t actually contain the active ingredients, but instead contained tramadol and acetaminophen, which are painkillers that do nothing for the treatment of attention deficit hyperactivity disorder (ADHD) or narcolepsy. More recently, in April 2013, the FDA warned that counterfeit Botox was being sold by unlicensed foreign manufacturers and distributors through a company called Online Botox Pharmacy. The company sent mass faxes to prospective customers. Unfortunately, however, many more incidences may still occur no matter what measures the FDA takes or how vigilant physicians are.

Identifying fake medicine is not easy.  However, there is one company that may be able to offer an additional safeguard. Applied DNA Sciences, based in Stony Brook, NY, is on a mission to create unique security solutions to address the counterfeiting challenges that today’s corporations and institutions face. Its flagship product, called SigNature DNA®, uses a marker derived from full double-stranded plant DNA. This product can be embedded into pharmaceuticals, ink, varnish, fabric, laminates, metal coatings and more, which can then be traced back to their source.

Dr. James A. Hayward, President and CEO of Applied DNA Sciences, says, “While the U.S. healthcare supply chain is still one of the most secure and sophisticated in the world, there is a growing network of rogue wholesale drug distributors selling potentially unsafe drugs in the U.S. market. We offer our technology to the healthcare community as an additional line of defense against counterfeit or unapproved drugs.”

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