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.While at the FDA, Josh Sharfstein has found ever more imaginative ways to waste taxpayer money. Millions of taxpayer dollars have been
But, give Sharfstein some credit. He has superb political instincts and understands precisely when it is time to go. Just after the new Chairman of the House Oversight Committee, Darrel Issa, announced that he intended to call hearings to examine some of the dodgy decisions at the FDA, Josh Sharfstein headed for the door. Could be a coincidence, or maybe there was no way he could justify the strange and often disastrous decision-making at the FDA that has so badly compromised a once-proud agency. Better by far, Sharfstein seems to have decided, to slip out the back door and let someone else take the heat for all the misdeeds.
Ironically, Sharfstein has now accepted a top public health job in the State of Maryland where he will be forced to deal with a huge number of small biotech companies working on a number of novel medical breakthroughs, but face impending insolvency because of an inability to navigate the increasingly complex myriad regulatory gauntlet at the FDA that has been erected. Good luck with that. Most likely, Sharfstein will get an earful, and, perhaps for the first time, learn the painful truth about the full costs of his misguided policies.
Issa has been straightforward about his intent to lead of the House Committee on Oversight and Government Reform in investigations of wasteful spending and other abuses of taxpayer trust. In an Administration which has overseen the ballooning of the federal workforce and increased federal spending over the last two years to reach a debt ceiling of $14 trillion, Issa’s oversight can’t start soon enough. Sharfstein’s resignation is just the first, early warning sign that Dems know that Issa means business.