Supply Chain Security
U.S. consumers currently benefit from of the world’s most secure prescription drug supply chain. The Food and Drug Administration (FDA) and the U.S. pharmaceutical industry are exceptionally vigilant against the distribution and sale of counterfeit and adulterated medicines. Filling 80% of the prescriptions in the U.S., the generic pharmaceutical industry is heavily vested in ensuring the security of the U.S. drug supply. GPhA believes that the problem of counterfeit medicines raises a very significant public health concern that must be addressed systemically on a range of levels—from local to global, and throughout the drug supply chain.
- The U.S. has the world's gold standard for ensuring the safety of our drug supply and protecting the public health must always be our number one priority.
- Low cost generic drugs are rarely if ever targeted by counterfeiters, who rather focus on more profitable and expensive brand-name products
- FDA has said, "counterfeiting is quite rare within the U.S. drug distribution system."
- GPhA knows of no instance of a counterfeit generic product occurring in the normal chain of distribution.
- In general, about 1-2% of drugs are targeted by counterfeiters. Imposing such broad measures as serialization of all products and the creation of an electronic track and trace pedigree system would raise costs considerably for generic medicines.
GPhA supports the Prescription Drug Marketing Act (PDMA), which requires pedigree to be provided when drugs passed outside of the "normal chain of distribution" (i.e., manufacturer to authorized distributor to pharmacy).
GPhA works side-by-side with other pharmaceutical and pharmacy trade groups, including the Healthcare Distribution and Management Association (HDMA), the National Association of Chain Drug Stores (NACDS), the National Community Pharmacists Association (NCPA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) in advocating for a safe prescription drug supply chain.
GPhA supports a national uniform track-and-trace system that would preempt a patchwork of varying state drug pedigree laws. We are committed to working with federal lawmakers to ensure that future pedigree laws will best serve consumer interests by being practical, focused, and uniform across the country to preclude the unintended consequence of erecting cost barriers to the distribution of affordable, safe and legal generic medicines.