Amgen is committed to the highest standards of drug quality and patient safety, and thus takes the issue of counterfeit drugs very seriously. Counterfeits by their nature are of unknown safety and efficacy, thereby putting patients at risk.
Our supply chain security 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 serialization and track-and-trace techniques to advance the security of the supply chain and protect its products and patients; and is collaborating with global regulatory agencies, including the U.S. Food and Drug Administration, and industry partners in this effort.
Amgen assists regulatory agencies in carrying out their responsibilities to protect the public health through the removal of counterfeit drugs from the marketplace. Upon receipt of credible information concerning distribution of any counterfeit Amgen product, Amgen informs regulatory agencies in an effort to help authorities take swift measures to protect the safety of the drug supply and initiate enforcement actions as appropriate.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. Amgen’s approved products have been proven safe and effective pursuant to regulatory standards for use within labeling instructions, and have helped millions of patients facing grievous illnesses.