The paucity of NME approvals by the FDA last year--a miserly 16, one of the worst records in decades--is attracting worried comment from all angles in the drug development business. Elliot Sigal, research chief at Bristol-Myers Squibb, tells the Star-Ledger that the low, low figure "is one measure of how hard it is" developing new drugs today. But the story also notes that a lineup of industry analysts and insiders is fingering a new mandate on caution at the FDA as the big culprit in the slowdown. The agency, though, deniesÂ that the debacle over Vioxx has made it any more cautious.
It's all been playing out well for biotech, though, which is home to what many see as a new generation of therapeutics as well as a rich source of new indications for existing therapies. That's a safer strategy to follow, but then maybe it's not just the regulators that are trying too hard to play it safe these days. Catering to a major unmet medical need requires a big appetite for risk taking, and the investment crowd has traditionally been leery of risk.
- here's the report from the Star-Ledger
Dry spell or parched desert for NME approvals? Report
New drug approval lags in 2007. Report
FDA quick to reject drugs as it gets more cautious. Report
Industry exec says FDA approval process too strict. Report