Sent: Thursday, November 03, 2011 11:17 AM
Subject: FY2011 Innovative Drug Approvals
You may have seen news reports or statements by industry that we are not “innovative,” or that we make it too hard for companies to get a new product on the market. But these broad-brush statements are, in most cases, inaccurate and unfair. They often lack important context that would explain our intentions and the work we do.
To help correct these misimpressions, CDER recently collaborated with the Commissioner’s Office, CBER, and many others throughout FDA on a report that highlights the innovative products approved by the agency in Fiscal Year 2011.
The report, released today, shows that in FY 2011, for CDER and CBER combined, FDA approved 35 new molecular entities (NMEs). These include innovative therapies for hepatitis C, late-stage prostate cancer, lupus, drug resistant skin infections, pneumonia, and other serious and life-threatening diseases.
The speed and efficiency with which these products were approved speaks directly to our staff and our high-quality reviews. It also demonstrates our willingness to exercise regulatory flexibility and creative approaches to help industry meet our standards—without lowering them.
FDA expedited the approval of many of these products by streamlining clinical trial requirements to permit smaller, shorter, or fewer studies wherever possible.
Here are a few highlights of the report:
FDA approved nearly half -- 16 -- of the innovative drugs under the agency’s “priority review” program for drugs that may offer major advances in treatment; priority reviews carry a six-month target date for review.
FDA approved all but one of the 35 products on or before the target dates for approval agreed to with industry under the Prescription Drug User Fee Act.
FDA approved the majority of these innovative drugs on the “first cycle,” that is, without requests for additional information that would trigger a second review cycle.
Continuing to enhance our efficiencies remains important, and in the near future I will be sharing with you some ideas on this topic. The positive messages highlighted in this report are a direct result of the combined hard work of all of us at CDER. Thanks to all of you! I am proud and appreciative to be part of the CDER team!
To view today's press release and the report, please visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278383.htm
FY2011 Innovative Drug Approvals Page: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276385.htm