Congress needs to update FDA regulations on diagnostic tests and cosmetics

Hand holding diagnostic test


Congress needs to update FDA regulations on diagnostic tests and cosmetics

Published date

December 5, 2022

Congress is considering two measures that modernize tools the Food and Drug Administration uses to oversee two areas of its vast portfolio: diagnostic tests and cosmetics. While the stakes are different for each of these industries, the basic premise driving these measures is the same.

The FDA is currently working from an outdated regulatory playbook that has left gaps in its oversight of safety and effectiveness and makes it more difficult to introduce new innovations. The new legislation would strengthen protections for consumers and patients for both diagnostic tests and cosmetics, and make it easier for manufacturers to introduce better products.

The provisions are being considered as policy riders to the spending bill that would fund the federal government for next year. It has taken almost two decades of debate and compromise to hammer out bipartisan proposals for these modernizations that have met the approval of most stakeholders. If these measures don’t pass now, it may take many years, along with many more setbacks and side effects, before there’s enough political momentum to get them this close to the finish line.

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Duke-Margolis Authors

Mark McClellan

Mark McClellan, MD, PhD

Director of Margolis Center
Robert J. Margolis, MD, Professor of Business, Medicine and Policy
Margolis Executive Core Faculty