Slowdown in approvals not safety related: FDA

Share this article:
FDA Office of New Drugs director John Jenkins said concerns over drug safety and "gaming" of the review clock were not to blame for a significant drop in first-cycle approvals, instead attributing the decline to historical fluctuations.

Speaking at a Citigroup Washington Biopharm Symposium, Jenkins pointed to the approval of new molecular entity (NME) drugs, where “historically about 75% of those submitted are eventually approved, and there is no evidence this has changed.”

There have been no management directives to either “speed up” or “slow down” reviews, he said. “A major factor supporting or limiting approval is the quality of the application and the data.”

FDA statistics show approval letters for standard-reviewed NMEs have been dropping over the past two years: 38% of the 16 NMEs submitted in 2003 were approved in their first review cycle, compared with 20% of 15 in 2004, and only 7% of the 14 in 2005. During the same period, the use of delay-causing “approvable” letters increased from 56% to about 64%.

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

Email Newsletters

MM&M Future Leaders

Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...