COMPETITIVENESS AND REGULATION: THE FDA AND THE FUTURE OF AMERICA’S BIOMEDICAL INDUSTRY

by CHI-California Healthcare Institute, February 2011

This is a report about the relationship between FDA regulation and the competitiveness of the U.S. biopharmaceutical and medical technology industry. Since the invention of biotechnology in California in the 1970s, America has emerged as the global leader in biomedical innovation.

What fueled this growth was an extraordinary public-private partnership, beginning with the National Institutes of Health (NIH), whose funding for basic research laid the scientific foundations for countless breakthroughs in drugs and medical devices. Basic research by itself, of course, was not enough. Developing and manufacturing products for patients required massive amounts of private investment, backed by investors willing to assume the risk that accompanies leading-edge science. Overall this partnership has produced great benefits, both for the American economy and for patients everywhere.

Beyond the relationship between the NIH and the private sector in discovery, though, there has been
another critically important partnership between industry and government centered at the FDA.  For when it comes to new drugs and devices, the Agency is the gatekeeper, deciding which products may enter the market, and under what conditions.  This is an enormously powerful, often underappreciated, role, with great implications for the economy and for public health.

The data presented here — gathered and analyzed by Simon Goodall and his team at the Boston Consulting Group — clearly indicate that today’s FDA is not keeping pace with U.S. biomedical innovation.

Read the Full Report