Some recent remarks on the new culture of innovation at the FDA by Commissioner Margaret Hamburg drew a caustic response from Skyline Ventures founder John Freund, a big investor in biotech companies over the years.
"Those of us on the front lines, who see innovative healthcare companies from the inside in a way the FDA does not, see the negative impacts of the FDA's approval process first hand on a daily basis," writes Freund in the Wall Street Journal.
Where Hamburg sees innovation, Freund sees new regulatory obstacles rising in front of developers. When the FDA raised the bar on safety for new diabetes drugs, he notes, the agency made it impossible for venture groups to invest in new diabetes treatments. Ditto for obesity drugs, he adds, after the FDA shot down three new treatments in the past year--including one which won the backing of an expert committee. New requirements for antibiotics, a field Skyline invested in with its backing for Tetraphase, is going to make that field tougher as well.
All of the changes, he adds, reflect the agency's tougher stance for mass market drugs, which is preventing innovation on new drugs that can work in big populations and forcing developers to concentrate on orphan products, where they can win approvals.
"Over the next decades, this will become a public health disaster unless the FDA can internalize the impact of its policies and revert to the scientific organization that a decade ago correctly weighed risk and reward for patients and allowed innovative new therapies to be created to reach them," writes Freund.
- here's the letter to the Wall Street Journal