Author
Dr. Nigel SB Rawson, Ph.D.
Introduction
With increasing life-cycle management of new drugs requiring evidence of real-world benefits and risks, a new era in post-approval drug evaluation is under way in North America and Europe. However, devising schemes and enacting legislation is relatively easy, whereas putting processes like the measurement of real-world benefits into action is more complex. Some important issues about evaluating drugs in the real-world need consideration.
Objective
This discussion article selectively references the literature to identify and examine the challenges to achieving greater certainty of the effectiveness of new drugs and explores the implications of increased regulatory burdens for patients, providers, regulators and pharmaceutical innovation.
Conclusion
Achieving scientific certainty of a drug’s effectiveness is a legitimate goal of regulators. Greater certainty of drug effectiveness could bring potential benefits for patients, providers and third-party payers like publicly funded drug programs and private sector insurers. However, achieving scientific certainty is also difficult and costly. Policy-makers must weigh the potential benefits against the costs, and have a better understanding of the social and economic trade-offs when deciding whether to impose higher regulatory standards for new drugs.
