THE NME approvals at FDA this year already equal the total approved for all of last year— 21 as of July 31—leading some FDA watchers to wonder if the new drug approval drought is over. For the past five years, the agency's Center for Drug Evaluation and Research has averaged 22 NME approvals annually.
“We're on our way to breaking the anemic pace of new drug approvals of recent years, but the problems underlying the relatively low rate of approvals since 2004 still need to be addressed,” said G. Steven Burrill, CEO of San Francisco-based financial service firm Burrill & Co.
In an August 1 Wall Street Journal op ed, FDA commissioner Margaret Hamburg said: “We hope this signals a larger trend in industry and at the FDA. Despite common criticisms that our agency impedes innovation by being slow and bureaucratic, we actually play a proactive role in promoting innovation by ushering new products through the approval process and to market—while making sure they meet the standards of safety and effectiveness that have served the American people well.”
While noting that industry's application quality is key to a speedy review, Hamburg acknowledged that the agency bears some responsibility for troubles in the review programs.