Counterfeiting is a lucrative business and recognizing the profit potential, criminal organizations are becoming increasingly involved in and responsible for the proliferation of a variety of counterfeit goods, including prescription drugs. The Food and Drug Administration (FDA) estimates that 40 million prescriptions were filled last year with counterfeit or adulterated medicine. That number is expected to rise as counterfeit drug sales are predicted to reach $75 billion by 2010, a 95 percent increase from 2005. Additionally, the FDA has seen a dramatic increase in the number of counterfeit investigations since 2000. In California alone, there currently are 20 open counterfeit drug investigations. Based upon these statistics, the appearance of counterfeit drugs in the U.S. supply chain has not diminished and remains a growing and persistent threat to public health. The 62 adulterated Heparin deaths (a blood thinner) illustrate the need to expeditiously track and isolate dangerous drugs before additional harm occurs.
California is at the forefront of the effort to secure the integrity of the pharmaceutical supply chain. The State has twice approved electronic pedigree legislation, which requires the tracking and tracing of prescription drugs through the supply chain to protect consumers from counterfeit, misbranded, adulterated or diverted drugs. Electronic pedigree, or e-pedigree, is an electronic record that contains information regarding each transaction resulting in a change of ownership of prescription drugs from the manufacturer through distribution by wholesalers to the final dispensation by pharmacies. When enacted, this law will prevent counterfeit drugs from entering the supply chain, allow law enforcement to better identify and prosecute counterfeiters and assist in the speedy location and removal of adulterated drugs from the hospitals and drug stores.
However, the current California law is not yet complete as a number of unresolved implementation issues still remain. As chair of the Senate committee that oversees the Board of Pharmacy, I have closely monitored this issue and have introduced legislation that clarifies issues not addressed in previous e-pedigree legislation. Senate Bill 1307 gives the industry additional time to meet the e-pedigree requirement, permits the Board of Pharmacy to grant another year extension if needed and establishes procedures for grandfathering existing drugs into the supply chain and the use of inference to validate delivery and receipt of drugs. I plan to use this bill to address additional industry concerns and have solicited their feedback.
There are many entities in the pharmaceutical industry that support California's e-pedigree efforts but there is a small, but vocal coalition that is less than enthusiastic about this requirement and have attempted to replace it with a model that, as the FDA and other industry partners have publicly testified, does not provide the same protections as an electronic pedigree.
In committee and to Members of the Legislature, some coalition members stated that there is no counterfeit drug threat and that the e-pedigree requirement is overly burdensome and unnecessary. But yet, those same entities have information posted on their website alerting the public of the dangers of counterfeit medicines and how to protect themselves from them; either there is a threat or there isn't. Even more perplexing about their position is that e-pedigree does not only help protect consumers from bad drugs, it also protects manufacturers from bad press, liability and counterfeit losses.
Other e-pedigree opponents have argued that California should defer to the federal government since drugs are manufactured, shipped and sold across the county. However, it has taken the federal government 20 years to adopt regulations required to implement the federal Prescription Drug Marketing Act (PDMA), which was passed to protect consumers from counterfeit or adulterated drugs. California did not wait for the federal government to act on environmental issues – why should we wait for them to act on this? Our consumers can not wait another 20 years and deserve to know that their medications are safe.
Moreover, similar technology is used in other industries to combat counterfeiting and protect the public. Airplane parts, automobiles and spare parts, computer equipment, DVDs, NASCAR tires and now even high-end wines use electronic track and trace technology to secure the delivery of a product to the end consumer. Granted, the volume and complexity of the pharmaceutical industry make e-pedigree implementation more difficult for other industries, but this does not, as some would have you believe, make the task impossible. It is time for the pharmaceutical industry to embrace 21st century technology and innovation to protect themselves, but most importantly, the public who rely on their products to treat illness and manage life threatening diseases.