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Genetic Labeling: Legal Uncertainty for Pharma Product Liability

By Shannon E. McClure and Whitney Mayer
January 01, 2018

Customization of products and services is becoming increasingly popular. Today, we can individualize anything from a salad to a car. In fact, surveys from Bain & Co. and Deloitte have confirmed that over one-third of consumers are interested in personalized products.

Advances in health care are making it more customized as well. Former President Barack Obama brought the discussion to center stage when he announced the Precision Medicine Initiative in his State of the Union Address in January 2015. Precision medicine challenges the idea of “one-size-fits-all” health care and considers individual variations in environmental, lifestyle, and genetic factors when developing and administering
treatment.

In the last 10 years, advances in technology have made precision medicine both scientifically and economically feasible. In 2003, when the concept of precision medicine was first addressed in mainstream health care, it cost $2.7 billion to sequence a human genome. Today, it costs only $2,900. Additionally, tests that measure gene expression, such as Northern and Western blots, have increased in accuracy and cost-effectiveness. These developments are key to finding more targeted treatments for cancer and rare diseases. Moreover, the explosion in affordable direct-to-consumer genetic testing (through companies like 23andMe) means that more personal information is in the hands of patients and their physicians.

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