'Burdensome' FDA drug approval process fuels innovation, saves lives

Forbes

28 February 2017 - I watched two speeches today that shared a common drug topic but with opposing philosophies. 

First, I saw former FDA director Rob Califf reflect on his recently-ended tenure at the agency while speaking to the Council for Entrepreneurial Development (CED) in Raleigh, NC. Then, like many of you, I watched President Trump's address this evening to a joint session of Congress.

The two men couldn't differ more in their views on how drugs and medical devices are developed in the United States.

Califf, a cardiologist, caught my attention today by saying, "Drug regulation drives innovation." He elaborated that the hurdles a new U.S. drug must meet in terms of safety and efficacy forces pharmaceutical companies to bring more first-in-class drugs or significant improvements over existing therapies to market.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , Process , Timelines