In a recent post on the IVI-sponsored Health Affairs featured blog series, Deborah Mazer and Gregory Curfman focus on provisions of the 21st Century Cures Act that will impact the FDA’s oversight of approved drugs and medical devices, including subtle changes to the approval procedures and a provision that permits-off label promotion of health care economic information. Mazer and Curfman make the point that consumers need to be aware of these changes and must understand that the evidence required for drug approval may be less rigorous than it has been in the past.
Read the full article here.
About the Health Affairs/IVI Featured Blog Series: Drugs and Medical Innovation — In partnership with Health Affairs, IVI is proud to sponsor the “Drugs and Medical Innovation” blog series. On an ongoing basis, articles in this series will explore topics such as value-based reimbursement, drug policy and pricing, balancing short-term access against long-term rates of innovation, and other relevant issues. Our goal is to create an open forum for sharing ideas and debating issues in these areas, extending the discussion to a broader audience.