Does increase in NME approvals signal trend?

Share this article:

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.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features


Reimagining healthcare? We want to hear about it.
 
Submit nominations here for MM&M's first-ever list of the Top 40 Healthcare Transformers

Email Newsletters

MM&M inVISION

More in Features

Is your marketing strategy stuck in 2005?

Is your marketing strategy stuck in 2005?

It is not enough to just have a killer black book or Rolodex. The market needs agile, swift marketing

Is guidance stifling social media?

Recent FDA draft guidance was meant to help companies create FDA-compliant tweets and handle third-party misinformation on the web. What other obstacles lie in the path of effective social media use?

Upward Move: Jose Rivera

Upward Move: Jose Rivera

Jose Rivera. EVP, account director, Concentric