Eli Lilly and Company announced an enhanced effort to combat the growing problem of counterfeit prescription drugs in the US drug supply. The rise in counterfeit drugs has been exacerbated by the illegal importation of products from Canada and other countries. The company has initiated a broad range of actions, including the addition of enhanced anticounterfeit technologies for Lilly products and packaging in its retail product portfolio and changes in its distribution system to protect patients as well as product integrity. In addition, Lilly is aggressively pursuing and litigating against those who manufacture and market counterfeit medicines.
The most common forms of counterfeiting include outright fakes; medicines that may be authentic but illegally labeled to show a higher concentration or an incorrect expiration date; generic drugs made for foreign markets, without the same regulatory safeguards as required by the FDA, then diverted for sale in the US; or drugs that have no active ingredient, a different active ingredient, or have been diluted or tampered with in some way.
"Counterfeiters are attempting to exploit the nation's drug supply, and they are doing so with little or no regard for patient care or safety," said Sidney Taurel, CEO of Eli Lilly. "The exploitative actions of these counterfeiters require Lilly to take the steps necessary to protect the patients who place their trust in our company and its products."
Taurel noted that the FDA's Counterfeit Drug Task Force Interim Report stated there is no single "magic bullet" against the growing number of sophisticated counterfeiters; rather, a multi-pronged strategy to secure the drug supply is much more difficult for counterfeiters to overcome than any single method. Lilly's multi-pronged strategy includes:
Using tamper-resistant and/or anticounterfeit technologies on all retail products - All products in Lilly's retail portfolio incorporate the use of tamper-resistant and/or anticounterfeit technologies.
Ongoing evaluation of anticounterfeit technology use on products - Lilly has incorporated anticounterfeit technologies for certain products and is continually evaluating the need for and use of multiple anticounterfeit technologies on products. The company is currently examining the use of emerging anticounterfeit technologies, including several pilot projects assessing the use of radio frequency identification (RFID).
Improving Lilly's coordination with US and international organizations - Lilly has taken actions to improve anticounterfeit efforts within various global coalitions and organizations (i.e., World Health Organization, World Trade Organization, Pharmaceutical Security Institute, and global regulatory agencies, etc). This includes sharing information on criminal activities, counterfeit investigations, anticounterfeit strategies and more.
Partnering with the FDA - Lilly, in conjunction with the FDA, is actively researching and monitoring counterfeit traffic of pharmaceuticals. In doing so, the company is working to identifying key elements of the criminal business model that allow counterfeit medicines to thrive. Additionally, and consistent with PhRMA's voluntary counterfeit reporting program, the company is sharing key information with the FDA's Forensic Chemistry Center to identify and respond to counterfeit Lilly products.
Developing and implementing anticounterfeit education and training programs - Lilly is developing and implementing education and training programs for internal and external customers regarding counterfeits Internally, the company has trained its Lilly Answers Center representatives (the company's customer call center) to better understand and handle specific counterfeiting situations. Externally, Lilly is working with the US Customs Office to develop a product manual that will include photos of and key information about all Lilly products to reduce the importation of counterfeit products and protect public health.
Implementing a wholesaler distribution agreement - Lilly requires its drug wholesalers in the US to purchase Lilly products exclusively from Lilly in order to limit the likelihood of counterfeit products entering the distribution system. The company tightly enforces this requirement and has terminated distribution agreements with five US drug wholesalers in the past six months who failed to comply with these terms.
Implementing a Canadian supply allocation system - In October 2003, Lilly began implementing a supply allocation system by which supplies of products made available to Canadian wholesalers is based on local Canadian demand. This system helps protect the integrity of Lilly products and the safety of patients in the US and Canada. Canadian pharmacies that engage in cross-border sales of pharmaceuticals pose a significant safety threat for U.S. patients. Their participation in the illegal importing of products into the United States opens the floodgates to potentially dangerous counterfeit and adulterated products in America's drug supply.
Monitoring and pursuing illegal Internet sales of counterfeit products - Lilly's legal and security divisions are actively monitoring numerous Internet websites that offer Lilly products or counterfeit versions of Lilly products to US consumers from locations around the world. When instances of wrongdoing have been identified, Lilly has given the information to appropriate government or legal authorities. In other instances, the company is actively pursuing legal action against Internet sources of counterfeit products. The company is working closely with the FDA's Office of Criminal Investigations in its pursuit of Web sites illegally selling counterfeit drugs in the US.
Litigating against counterfeiting and other illegal operations - Lilly is aggressively using its legal resources to initiate civil and criminal litigation against those who counterfeit Lilly medicines, or who market unauthorized copies of Lilly products. In a recent case, Lilly partnered with the legal authorities in Colombia to raid a local manufacturer's facilities where a version of Lilly's osteoporosis prevention treatment was being produced illegally. This resulted in seizure of illegitimate product before it could be sold to patients in Colombia or shipped abroad. This effort marked the first criminal prosecution of its kind by Colombian authorities.
Creating an anticounterfeit task force - Lilly has developed a cross-functional task force to examine new and better ways for the company to combat counterfeiters. The task force evaluates Lilly business processes and strategies related to product protection and drives company policies on pharmaceutical counterfeiting. In addition, the task force includes a technical group responsible for exploring cutting-edge product protection technologies and coordinating the analysis of suspect products obtained from illegal supply chains. The task force reports to a senior executive committee responsible for global quality of Lilly pharmaceuticals.
Establishing of a global product protection division - Over the past 12 months, Lilly has developed a global product protection division dedicated to protecting consumers from counterfeit products. This year, the company increased staff and doubled the budget for this division. Its staff includes lawyers, manufacturing and quality control personnel, scientists, and security personnel both in the United States and overseas to coordinate anticounterfeit efforts. To date, the staff has gathered evidence on 30 counterfeiting operations in seven countries. Lilly has turned its evidence over to government and law enforcement authorities, who have prosecuted all 30 cases.