21st Century Cures Initiative: Regulation and Innovation

Peter Salgo, MD, and Bryan Loy, MD, discuss the focus of the 21st Century Cures Initiative recently launched by the US Congress and describe strategies to help promote innovation in medical oncology.

Dr Loy explains that the Initiative’s focus is to facilitate innovation by addressing various barriers that affect the development of new treatment options.

Because the Initiative is designed to allow various stakeholders in healthcare to share their opinions about how to accelerate the pace of healthcare innovation in the United States, a rapid acceleration in the pace of innovation is expected. However, Dr Loy notes the discussions required by the Initiative may be insufficient, and comments that conversations among various stakeholders regarding how to review and ultimately utilize newer treatment options are necessary.

During the drug development process, pharmaceutical companies are often concerned about regulatory and reimbursement risks. Dr Loy explains that adopting an approach in which risk is shared among various parties can help lower the costs associated with research.

Additionally, Dr Loy suggests that involving multiple stakeholders (including the FDA, payers, physicians, and patients) early in the clinical trial design process can help speed innovation and have a positive impact on patient care.

Watch our related Peer Exchange, Oncology Stakeholder Summit 2014: Evidence-Based Decisions to Improve Quality and Regulate Costs