Attacking the Problem From Many Angles

The FDA has created an internal task force to help combat the growing problem of counterfeit drugs. This task force is exploring the use of modern technologies and other measures against counterfeiting. These measures will make it more difficult for counterfeit drugs to take the place of safe and effective drugs.

Likewise, AstraZeneca has established a multifunctional team to deal with counterfeiting across our US business. The team includes representatives from many internal departments, including operations, commercial, legal, public affairs, strategic planning, managed care, global product security, and quality assurance.

Internal mobilization

Our team’s mission is to:

• Raise awareness among AstraZeneca employees of issues related to counterfeiting.
• Drive decisions and actions to help fight counterfeiting.
• Resolve the many complex issues arising from the counterfeiting problem.

Patient and product protection

We are concentrating our efforts on key areas, including:

• Redesigning our packaging to employ anticounterfeiting features. These features are already in use for some of our products. They are currently being evaluated across all products.
• Establishing a surveillance program to monitor potential counterfeiting operations. This monitoring will include both Internet-based activities and activities focusing on the supply chain.
• Working to ensure that our relationships with wholesalers promote a safe and secure supply of medicines. This effort includes enhanced audit and enforcement capabilities.
• Conducting feasibility studies on technical advances, such as the use of radio frequency identification (RFID) technology on our products. This technology may allow the establishment of an electronic pedigree for all products at the unit level.

External activities

AstraZeneca is working with the FDA to identify counterfeit drugs and prevent counterfeiting, and we will cooperate with the FDA in providing information and notifying the FDA of any potential counterfeiting we discover. As a multinational company, we are also collaborating with authorities internationally to help solve this problem.

Steps we have taken to confront this issue include:

• Joining the voluntary program of the Pharmaceutical Research and Manufacturers of America (PhRMA) to report counterfeit drugs to the FDA
• Pledging our full support to law enforcement and to the FDA’s Office of Criminal Investigation (OCI) in its efforts to secure the US drug supply chain
• Supporting legislation and enforcement of tougher regulations
• Aggressively pursuing anyone who manufactures and/or sells counterfeit versions of our products
• Supporting increased awareness and education about counterfeiting for patients and health care professionals