Reforms Needed to Modernize the US Food and Drug Administration’s Oversight of Dietary Supplements, Cosmetics, and Diagnostic Tests

Congress is in the process of reauthorizing the user fee programs that help fund operations of the US Food and Drug Administration (FDA), but legislators could not reach final agreement on 3 major provisions intended to modernize the agency’s regulatory framework, advance innovation, and strengthen its ability to protect consumers. These provisions address the FDA’s oversight of dietary supplements, cosmetics, and diagnostic tests for patients—and represent once-in-a-generation reforms developed through a largely bipartisan process.

All 3 industries are benefiting from technological advances that offer new opportunities to improve people’s health, but also create new uncertainties and risks. For each of these industries, evidence indicates that products that slipped through a porous regulatory framework have put some individuals at risk. Industry participants have also expressed concerns about difficulties in advancing potentially beneficial new kinds of innovations under the FDA’s existing regulatory authorities, which have not kept up with the market’s current state.

The 3 provisions were years in the making. Aspects of each took shape while we individually served as FDA commissioner at 2 points over the last 20 years,1 reflecting how long the FDA and many of its stakeholders have sought these new measures. Their absence from the final bill reauthorizing the FDA’s user fee programs is a profound missed opportunity.

Congress could authorize these measures later this year when legislation to fund the federal government for the coming year is expected to pass. But that prospect is slim unless there is a strong bipartisan commitment to enact them.

Read the full text.