Congressman Darrell Issa’s chairmanship of the House Committee on Oversight and Government Reform has already had an effect on Democrats in the Obama Administration, even before Issa has hosted a congressional oversight hearing. The announcement of the resignation of Josh Sharfstein, the Deputy Commissioner at Food and Drug Administration (FDA), is likely just the first of many such resignations that will occur as Executive agency leaders in the Obama Administration realize that their misguided policies can’t stand up to public scrutiny.
During the short tenure of Josh Sharfstein at the FDA, innovation in drug development has slowed to a crawl, as new regulatory burdens have been added and the cost of navigating the increasingly complex FDA regulatory cycle have mushroomed. Sharfstein seems to have come to the FDA with a notion that there is an insufficient amount of regulation, oversight and complex rule making.
Without ever having spent a day in a private company devoting time, energy and capital toward making better medical products, devices, drugs and novel therapies, Sharfstein seems to have come to the conclusion that most, if not all, of our pharmaceutical, medical device, and biotech companies are in need of vast, new, regulatory burdens and bureaucratic uncertainty. The impact of this mindset was all too predictable: drug development costs have soared, while innovation in novel techniques that Americans once took for granted has stalled.
Ten years ago, the FDA approved over 50 new drugs per year. Today, that rate has dropped to just about 10 new drugs a year. And, this surprising drop occurs at a time when pharmaceutical companies have dramatically increased their research and development efforts. So, the sharp reduction in drugs undergoing trials is certainly not because the drug companies are experimenting less. Yet, the FDA budget has increased, in just two years, from $2 Billion in 2008 to $3.2B in 2010. Not too surprisingly, as a direct result of the leadership of Josh Sharfstein, America’s once unrivaled leadership in medicine and novel drug development is now seriously challenged by other nations that have been wiser.