Amgen takes the issue of counterfeit drugs very seriously and is committed to the highest standards of drug quality and patient safety. Counterfeits by their nature are of unknown safety and efficacy, thereby putting patients at risk.
Our brand protection program supports an effective, secure, and resilient global supply chain, and the overall integrity of Amgen’s medicines, for the protection and safety of our patients. Some of the measures Amgen is employing to deter, detect, and disrupt the criminal counterfeiting of our medicines include:
- Employing sophisticated technology to hamper the ability of counterfeiters to create packaging that resembles Amgen's.
- Requiring wholesalers to buy only directly from Amgen, and auditing compliance with these purchasing practices.
- Partnering with federal and state law enforcement agencies to investigate and prosecute those involved in product tampering and counterfeiting, facilitating the arrest and conviction of counterfeiters.
Amgen supports the use of appropriate track-and-trace techniques to advance the security of the supply chain and protect its products and patients and is collaborating with the FDA and industry partners to develop appropriate RFID implementation requirements. However, due to unresolved concerns about the effectiveness and feasibility of RFID technology, Amgen opposes the imposition of RFID requirements for biologics at this time.
Amgen assisted the Pharmaceutical Research and Manufacturers of America (PhRMA) with the development of PhRMA's voluntary program to report counterfeit drugs to the FDA. Amgen participates in the program, designed to assist the FDA in carrying out its responsibilities to protect the public's health by removing counterfeit drugs from the marketplace. Upon receipt of credible information concerning distribution of any counterfeit Amgen product, Amgen will inform the FDA in an effort to further help the agency take swift enforcement action.
Amgen’s mission is to discover, develop and manufacture medicines that dramatically improve people’s lives. Amgen’s FDA-approved products have been proven safe and effective pursuant to FDA standards for use within labeling instructions, and have helped millions of patients facing grievous illnesses. Amgen’s brand protection program supports this mission.
For additional information about drug counterfeiting, visit: