What No One Is Talking About Regarding Traceability

By Rob Wright, Chief Editor, Life Science Leader
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By Rob Wright

In February, Genentech, the maker of the best-selling cancer drug, Avastin, issued a warning to doctors and patients, noting that the counterfeit vials of the distributed product did not contain the key ingredient used to treat cancers of the colon, lung, kidney, and brain. Charlotte Arnold, a spokeswoman for Genentech, said the counterfeit drug had been distributed to healthcare facilities in the United States, though it is unclear how many products are in circulation or where they may be concentrated. In addition, Arnold said the company was alerted to the problem by foreign health regulators. Unfortunately, this is not the first time Avastin has been the target of counterfeit. For example, in 2010, patients in China were given a drug thought to be Avastin which turned out to be saline contaminated with bacteria endotoxin. Another example of a deliberate drug contamination occurred in 2008 when contaminated heparin was connected with dozens of deaths and hundreds of allergic reactions across the United States. The FDA investigation concluded that the drug had been intentionally contaminated. Thirty years ago, Johnson & Johnson (NYSE: JNJ) experienced deliberate contamination of its market leading product, Tylenol. This event resulted in the death of seven people, resulted in the creation of industrywide tamper-resistant packaging, and cost J&J more than $100 million. Here is why all of these events are significant.

Tamper-resistant packaging has created a level of trust among U.S. consumers. Patients trust that the medication being injected by a healthcare provider is safe. Patients trust the person giving the injection. In a Gallup Poll, 84% of Americans rated nurses’ honesty and ethics as “very high” or “high.” That being said, when was the last time you asked the nurse (the person most likely to give an injection) if they checked the tamper-resistant packaging and if anything seemed amiss. Recent counterfeits of Avastin demonstrate the ability of counterfeiters to closely copy company drug labeling and successfully circumvent the current drug distribution system. For those people intent on launching a bioterrorist event, the best way to do so is to either tamper with a product prior to it being packaged or create a copy that looks just like the product and place it in the hands of trusted healthcare providers for administration. Bioterrorism remains and distinct possibility without a program that involves the ability to trace medications back to their manufacture to ensure the contents have not been adulterated. So what is being done?

The Risk Of Legislation Procrastination
Recent legislation introduced in the United States House of Representatives would create a mandatory bar code system to monitor the authenticity of all prescription drugs moving through the U.S. supply chain. The legislation is known as the Pharmaceutical Traceability Enhancement Code (RxTEC) Act and was introduced earlier this year. But the importance of traceability is nothing new. In July 2003, U.S. FDA commissioner Mark McClellan established the counterfeit drug task force. In a report issued in 2004, the task force concluded that the adoption and common use of reliable track-and-trace technology based on radio-frequency identification (RFID) tagging of products was feasible for use by 2007, and the report recommended universal pedigree requirements to document all drug movements. And yet, eight years later, a federally mandated traceability program has yet to go into effect. The state of California’s board of pharmacy began the process of taking action nearly 10 years ago, laying out an ePedigree law scheduled to begin going into effect in 2015. Its intent — to secure the drug distribution system from the threat posed by counterfeit, misbranded, adulterated, or diverted drugs. The problem with RxTEC is that it is not as robust as the California ePedigree law, and if passed, would supersede the California law. Finally, it won’t go into effect until 2020. Traceability and serialization are not easy issues. But procrastination on legislation which leads to delayed implementation is simply providing those intent on causing harm, a greater opportunity to do so.