Standard US NME appros suffering

The more difficult US regulatory environment that pharmaceutical industry officials have warned of in the last two years may now be evident in the Food and Drug Administration Center for Drug Evaluation and Research's first-cycle review outcomes for standard New Molecular Entities and Bioligical License Applications, according to a newly-released report entitled, the US Drug Approval Trends and Yearbook 2006/2007, available at: www.barnettinternational.com.

The compendium points out that first-cycle approval rates for standard NME/BLAs have bottomed out from a several-year high of 38% for the fiscal year 2003 cohort of NME/BLAs to roughly 8% for the FY2005 group (as of August 31, 2006, when a single FY2005 application was still pending a first action). The 8% first-cycle approval rate would be an all-time low for standard NME/ BLAs during the user-fee era. Fully 20% of FY2004 NME/BLA applications received first-cycle approvals, according to the new yearbook.

Although there has been some anecdotal evidence and many industry claims of a toughening regulatory environment for new drug approvals, what many interpret as the FDA's response to drug safety concerns following the Vioxx (rofecoxib) withdrawal in 2004, there has been little hard evidence to support such claims until now. In fact, the new yearbook reports that a little over 70% of FY005 priority NME/BLAs received first-cycle approvals, a three-year high and the third highest level during the user-fee era. The review outcomes for New Drug Approvals overall continue to be positive as well.