Tuesday, December 13, 2016

Patients Lose Patience

Although December 13, 2016, would not seem the most propitious of dates, it may go down as an important one in the history of United States drug and medical device law.  Today, President Barack Obama signed into law the "21st Century Cures Act", which substantially amends the Food, Drug, and Cosmetics Act ("FDCA") in response, at least in part, to a growing chorus of criticism by patient advocates demanding faster approvals of, and access to, new drugs and medical devices.  Among the highlights are formal recognition by the Food and Drug Administration ("FDA") of "patient experience" data as part of the drug approval process, accelerated decisions on drug approvals, reevaluation of clinical trial design (including consideration of "real world evidence"), enhanced access by patients to information on experimental drugs, accelerated approvals for regenerative medicines (including, presumably, stem cell therapies), and accelerated approvals for medical devices.  The 21st Century Cures Act is one of the most substantial amendments to be made to the FDCA in years.  It may prove one of President Obama's greatest legislative legacies, with wide-ranging and long-lasting effects on medicine and health.

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