We make medicines for some of the world’s most serious and life-threatening diseases, and protecting patient safety at each step of the supply chain is critical. We are committed to ensuring people can safely access our medicines when they need them.
Illegitimate medicines – medicines that may be counterfeit, adulterated, diverted or illegally imported - continue to pose a significant global threat to patient safety. These medicines are neither safe nor effective and have significant negative implications for public health. Several factors, such as technological advancements, globalization and the Internet, have enabled counterfeiters to more easily manufacture counterfeit goods and introduce illegitimate medicines into the supply chain.
Counterfeit medicines are those that have been deliberately and fraudulently mislabeled with respect to source and/or identity in a way that suggests that the drug is the authentic approved product. Analysis of seized counterfeit medicines has shown that they may contain:
Some counterfeits look so similar to the genuine products that they deceive both healthcare professionals and patients alike.
Diverted medicines are legitimate pharmaceutical products approved and intended for sale in one market, but then illegally intercepted and sold in another market. Diverted pharmaceuticals are a significant crime threat for the United States. These diverted, illegally imported, and in some cases stolen, medicines are immediately unsafe for patients as they may be:
Genentech employs several strategies to combat the global threat of illegitimate medicines, and we continuously assess and enhance our product security strategies to ensure patients do not receive unsafe medicines. These strategies include:
One of the strategies Genentech has been working on implementing to combat illegitimate medicines is Serialization. Serialization is the inclusion of unique product identifying serial numbers on our products and is being mandated industry-wide by the US Drug Supply Chain Security Act (DSCSA). We believe serialization is a core security technology that will further protect our patients, products and company reputation by supporting the prevention of illegitimate drugs being introduced into the U.S. supply chain.
The DSCSA was enacted by Congress in November 2013 to enhance the ability of the U.S. Food and Drug Administration (FDA) to protect consumers from drugs that may be counterfeited, stolen, contaminated or otherwise harmful. The DSCSA implementation will be phased in over a 10-year period (2013-2023) with successive requirements for manufacturers, wholesalers/distributors and dispensers.
Genentech is taking all necessary steps, including partnering with key stakeholders across the Pharmaceutical industry, for successful and timely implementation of DSCSA milestones.
Advise patients to: