The FDA’s latest effort at transparency in the drug GMP inspection planning process can be found in the new Manual of Policies and Procedures (MAPP) 5014.1, “Understanding CDER’s Risk-Based Site Selection Model,” used to prioritize sites for routine surveillance GMP inspections.
Looking forward, the U.S. pharmaceutical industry needs to be aware that despite the FDA’s year-long delay in enforcement, the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.
Serialization in the pharmaceutical sector is a direct response to the problems of counterfeit, stolen, and gray-market drugs. There’s been a huge incentive for counterfeiters to duplicate high-profit-margin products. According to the 2016 Brand Protection and Product Traceability Market Research Report from PMMI, the black market for counterfeit drugs is about $75 billion annually.
Regulators in China have long been concerned that this multitiered network inflates drug prices. A 2017 pilot program, known as the “two-invoices” system, aims to address this issue by changing the way manufacturers, distributors, and healthcare facilities operate in the procurement process.