Lilly responds to US counterfeiting request

Lilly was one of five drug makers asked last month​ for information on the measures they are taking to combat the faking and diversion of prescription drugs.

Among the measures identified by the drug company are the introduction of tamper-resistant packaging across all its retail product lines, as well as other anticounterfeiting technologies to improve the security of packaging.

The company is also evaluating a number of systems to make it more difficult for the drug fakers, and has a number of pilot projects ongoing looking at radio-frequency identification (RFID). Lilly said it has set up a taskforce to look specifically at the counterfeiting issue, including a technical group responsible for exploring cutting-edge product protection technologies as well as analysing suspect products.

However, Lilly has identified illegal importation of products from Canada and other countries as being central to the problem of drug counterfeiting, and most of its measures are aimed at tackling it at the level of supply chain management.

For example, Lilly requires its drug wholesalers in the US to purchase its 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.

Meanwhile, last October it started up a Canadian supply allocation system, in which supplies of products made available to Canadian wholesalers is based on local Canadian demand. This system is designed to prevent the re-importation of cheaper Canadian drugs onto the US market, a movement of goods which has become popular as health care payers in the US struggle to contain rising prescription drug bills.

"Canadian pharmacies that engage in cross-border sales of pharmaceuticals pose a significant safety threat for US patients,"​claimed Lilly, adding that this trade "opens the floodgates to potentially dangerous counterfeit and adulterated products in America's drug supply".​

Another strand to the effort will be a monitoring exercise to identify Internet sites and other commercial operations that offer Lilly drugs and ascertain whether these are legitimate or counterfeit. The company will either litigate cases of wrongdoing on its own behalf or bring the activities to the attention of the relevant authorities.

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 the 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.

Lilly is also working with the US Customs Office to develop a product manual that will include photos and key information on all of the firm's products.

On the corporate level, Lilly has set up a new division specifically to tackle the issue of product protection, including lawyers, manufacturing and quality control personnel, scientists, and security personnel both in the US and overseas to coordinate anticounterfeit efforts.

To date, the division 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 of these cases.

The other companies approached by the congressional committee were Pfizer, GlaxoSmithKline, Johnson & Johnson and Serono, all of which have had problems with high-profile counterfeiting cases.

Some of the medicines that are particularly prone to counterfeiting include Pfizer's cholesterol drug Lipitor (atorvastatin) and erectile dysfunction drug Viagra (sildenafil), Johnson & Johnson's red blood cell booster Procrit (epoetin alpha) and GSK's HIV treatments, notably Combivir (zidovudine plus lamivudine).

Serono has been approached because its growth hormone product Serostim (somatropin) is also a favourite of the counterfeiters.