STAT 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The FDA is currently working from an outdated regulatory playbook that has left gaps in its oversight of safety and effectiveness and makes it more difficult to introduce new innovations.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...