Track & Trace: Developing a National Pedigree Program

In today’s world, Track and Trace for pharmaceutical industry is becoming the new standard. Other countries, including China, are looking at moving to systems that can keep track of drugs and help regulators and the industry thwart counterfeiters. Last year California passed a “Pedigree Law” requiring Prescription drug manufacturers who want to continue offering their products to patients within California after 2015-2016, to add unique serial numbers on each drug package and start an electronic drug pedigree.

Drug manufacturers and distributors work together in a robust system to deliver high-quality products, but our pharmaceutical supply has become increasingly complex in recent years. Medicines originate in factories all over the world, moving into the American marketplace through supply chains that can involve numerous processing plants, manufacturers, suppliers, brokers, packagers and distributors. This graphic presents and overview of today’s globalized pharmaceutical supply chain and examines vulnerabilities that have allowed substandard and counterfeit products to enter the system. For the interactive graphic, click on the image.

Click on the image to view the interactive file

The number of drug products made outside of the United States doubled from 2001 to 2008, according to FDA estimates. The FDA estimates that up to 40 percent of finished drugs used by U.S. patients is manufactured abroad, and 80 percent of active ingredients and bulk chemicals used in U.S. drugs comes from foreign countries. Increasingly, the United States relies on drug manufacturing in developing countries—mainly China and India. Globalization, increased outsourcing of manufacturing, the complexity of pharmaceutical distribution and the existence of criminal actors willing to capitalize on supply chain weaknesses has created the potential for counterfeit or substandard medicines to enter the system and reach patients. As evidenced by the adulteration of heparin and other case studies outlined in this report, these rare but potentially serious events can have grave consequences. RXP_AfterHeparinInfographic_725x1459_ks_OWN

The industry actually wants to get something on the books that would preempt a California law that would require unit tracking starting in 2015. Last month, officials with three of the leading drug and delivery associations wrote an op-ed piece for Politico calling for a system that would use technology to “determine the product’s source and distribution history; provide “immediate protection” as well as use a “building block approach” for enhancements; give the FDA authority for the system and apply the “efficient, cost-effective system” to all 50 states.

A bill being pushed by U.S. House Republicans would start the process for tracking lots of drug units through the supply chain but would not allow the FDA to even consider tracking on the unit level until 2017, Reuters reports. A bill in the Senate, where Democrats hold sway, would phase in unit tracking much sooner, which the FDA has asked for. It is these extreme differences in point of view that kept legislation from being included in the FDA funding bill last year. As other states are considering similar legislation, the race is on at the federal level to pass a national Pedigree/Track & Trace law for the whole country.

Why can’t we leave this to the state’s to decide? Differences in state legislation could add significant costs to the system, possibly making it cost restrictive to sell products in some markets. Patient safety is always paramount for the industry and the incidence of tainted materials and counterfeit products all can be addressed under a national system, controlled by the FDA.

This is a conversation, not an editorial. Did I forget something, get it wrong or do you agree? Please Comment, Like, Re-Tweet and Share.

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