Scientific Publications by FDA Staff

Clin Pharmacol Ther 2012 Oct;92(4):486-93

Advancing the Science of Medicines Regulation: The Role of the 21st-Century Medicines Regulator.

Lumpkin MM, Eichler HG, Breckenridge A, Hamburg MA, Lonngren T, Woods K

The history of medicines regulation is punctuated with sudden swings in focus mandated by a public injured by medicines and skeptical of regulators' abilities to protect them. As stakeholder communities and the science that undergirds medicines have both grown more sophisticated, seemingly conflicting mission equities, such as public health protection vs. promotion or population vs. individual patient product development focus, have created new challenges to defining the mission and role of twenty-first-century medicines regulators. The role of medicines regulators as a nationally focused, retrospective assessor of data is rapidly shifting to that of a prospective generator of public data and tools to help drive what has now become a global product development and regulatory enterprise that is fast gaining recognition as an integral part of any truly effective twenty-first-century health-care system. This article discusses this evolution and describes how regulatory science will help to both drive and define it.Clinical Pharmacology & Therapeutics (2012); advance online publication 5 September 2012. doi:10.1038/clpt.2012.146.