MORNING CONSULT | The FDA’s warning letter Anne Wojcicki received as the CEO of 23andMe in November 2013 came as a shock to the direct-to-consumer product industry dealing in the “peri-medical” device space. The Food and Drug Administration (FDA) had not previously made such a move, and perhaps 23andMe was being used to set an example, but nonetheless, the action was at the time unprecedented. 23andMe could no longer provide consumers with information about potential disease markers in their genome sequence.
The FDA was signaling it would now regulate the burgeoning field of consumer genomics. As Dr. Margaret Hamburg, the FDA Commissioner who stepped down from her role last week, explained, the FDA has “an enormous set of responsibilities that every day get bigger…” In fact, FDA-regulated products account for about 25 cents of every dollar spent by American consumers each year. And the agency is continuing to expand its reach by announcing plans to regulate digital medical devices like apps and wearables, as well as Laboratory Diagnostic Tests (LDTs).
Why does this matter? Today’s drug and device development process costs too much and takes too long. It now takes a decade or more and well over a billion dollars for the average drug to make it to market—a dramatic jump compared to $300 million in 1987 and $100 million in 1975 (adjusted for inflation). As a result, venture capital investment in medical technology has declined by 42% between 2007 and 2013. A 2011 survey by the National Venture Capital Association found that over 60% of their members cite FDA regulatory challenges as reason for shifting away from biotech & medical device investment.
No one wants the FDA to approve drugs or devices that haven’t been properly vetted or could be dangerous to the public. But we also must make sure we aren’t stifling innovation and deterring investment in the name of safety. An inefficient, outdated FDA drives up costs for consumers, delays patient access to lifesaving medications and devices, deters private investment in medical innovation, and encourages companies and investors to move overseas.
What can we do to reverse this trend? Congress must act.
Read more at Morning Consult: https://morningconsult.com/opinions/fda-reform/