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Counterfeit Cialis and questions of counterfeit drugs

Posted by Kees Riphagen on Feb 12, 2015 11:45:00 AM
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Counterfeit Cialis and questions of counterfeit drugs

In light of the recent announcement by the U.S. Food and Drug Administration that counterfeit versions of the drug Cialis were found in the mail en route to a U.S. customer, we thought it would be a good time to go over some basic facts about prescription drug counterfeiting in America.

Counterfeit versions of Cialis, an erectile dysfunction drug also known colloquially as "the weekender," were detected in FDA laboratory analysis recently, according to a notice posted on the regulator's website. While this shipment was stopped, the FDA explained that it remains concerned that other mail shipments got through to consumers.

"A full 37 percent of seized counterfeit drugs are for erectile dysfunction."

Lab analysis showed that the counterfeit versions contained multiple active ingredients which could result in adverse effects or harm if used. Perhaps just as serious, the illicit nature of counterfeit drug making means that the FDA is unable to confirm that the manufacturing, quality, storage and handling of such products follow U.S. standards. Luckily, the regulator said that it has no indication that the legitimate supply chain for Cialis is compromised by counterfeiters, meaning that licensed pharmacies in the U.S. remain safe.

Originally, the FDA sought to ban what it identified as the Cialis made at Eli Lilly's plant in West Ryde, Australia, after testing showed that it contained not just tadalafil - the legitimate active ingredient - but also sildenafil - the active ingredient in Viagra - according to FiercePharmaManufacturing. When Lilly, the company that owns Cialis, responded that it stopped manufacturing human drugs in Australia in 1985 and that even its animal health operation stopped making products there in 2008, the recovered drugs were identified as counterfeits. Eli Lilly noted that a full 37 percent of seized counterfeit drugs are for erectile dysfunction.

Counterfeit drugs present a serious health and safety risk around the world.Counterfeit drugs present a serious health and safety risk around the world.

Drug counterfeiting
Counterfeit drug manufacturing is a heinous problem around the world. Because of the black market nature of this activity, it is impossible to know precisely the extent of drug counterfeiting, but anti-counterfeit measures taken by the FDA and other U.S. regulators have proven successful in limiting this problem domestically. In Africa and other developing nations, drug counterfeiting is rampant. 

"Because pills are easy to duplicate from a visual perspective, often the best protection is traceability."

Regardless, fake prescription drugs still get through. In particular, drugs ordered online pose a serious risk. In 2012, The Wall Street Journal reported on vials of the cancer medicine Avastin which were determined to contain no active ingredient

Pharmaceutical companies cannot afford to have their supply chain compromised, or allow the sale of illicit products.  The price of authentic medicines drives counterfeiters to manufacture products, and drives consumers - especially the uninsured - to search for cheaper medicine in the online space.

Counterfeiters often turn to the internet to sell their fake and substandard product because it provides a virtually anonymous venue on which to conduct business. To combat this problem in the online space, a robust online brand protection program is necessary. The program must find and enforce against illicit listings and sellers across B2B trade boards, online marketplaces and online pharmacies. Often, these sites are home to large networks of sellers offering fake and substandard goods. In fact, only a very small handful of online pharmacies are VIPPS-accredited by the National Association of Boards of Pharmacy.

There have been numerous other cases in which individuals have been hurt or killed by illegal prescription drugs. Particularly scary have been the few times when counterfeit drugs have made their way into the legitimate supply chain, causing them to be dispensed by licensed pharmacies.

The World Health Organization estimates that between 1% and 10% of drugs sold around the world are counterfeits. In some countries, that number could be as high as 50%. Brand protection programs for this industry are especially important because they help tackle a serious, world-wide safety concern. By following the supply chain diligently, regulators, enforcers and third-party companies like OpSec can help to ensure that only legitimate prescription drugs make it to consumers. Unlike with other counterfeit products, where the potential for harm is mostly limited to wasted money on the consumer's part and lost reputation and money on the vendor's part, counterfeit drugs present a serious health and safety risk. 

OpSec remains dedicated to eliminating counterfeiting wherever possible, especially with regard to prescription drugs.


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Topics: Online Brand Protection, Supply Chain Tracking, AntiCounterfeiting

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