FDA wants to help unproductive drug makers

The Economist

22 March 2018 - America’s pharmaceutical giants may also need to rethink their business model.

Scott Gottlieb, the thoughtful head of America’s FDA, has had a busy first year. He has launched the process of lowering nicotine levels in cigarettes, approved self-testing kits for breast-cancer genes and waved through the most new medicines in two decades, as well as a record number of copycat drugs. 

There is one thing he and his regulatory agency are doing less of, however—regulating. New rules were at a 20-year low in 2017, according to analysts at PwC, a consultancy. Instead, the FDA is providing more guidance to industry. This approach, Mr Gottlieb hopes, will help pharmaceutical firms in America develop drugs more efficiently. Since that is where most drug development happens, the FDA’s philosophy matters beyond American borders.

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Michael Wonder

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Michael Wonder