The Legal Environment for Precision Medicine

Clinical Pharmacology & Therapeutics February 2017

James A. Boiani and Bradley Merrill Thompson, Members of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in Clinical Pharmacology & Therapeutics, titled “The Legal Environment for Precision Medicine.”

Following is an excerpt:

Every person is different. Each of us has a different combination of genetics, environments, and lifestyles that make us unique. While this uniqueness offers great benefits to our society, it also creates a conundrum in medical care: How do we know the best course of therapy for a given patient?

“Precision medicine” looks for ways to improve healthcare by developing personalized approaches to care that are tailored to benefit unique patients. The concept is not new—it dates back to apothecaries compounding tinctures for patients. But the objective today is to marry our advances in knowledge and regulatory science with personalization. Success depends on the imagination of innovators in developing products, and the creativity of regulators in adapting the legal environment to changing technologies.