Second annual study of FDA drug review released

PAREXEL Consulting, a business unit of PAREXEL International (Nasdaq: PRXL) and a leading global life sciences consultancy serving the biopharmaceutical and medical device industries, today released its second annual study on the state of the U.S. Food and Drug Administration (FDA) drug review process. The PAREXEL Consulting analysis, contained in the new white paper entitled "The Innovation Imperative in the Safety First Era," provides insight into how regulatory changes and marketplace dynamics are impacting new drug review times and review outcomes.

"The implications of FDAAA and CDER's implementation of the law have been widely discussed, and there is considerable conjecture in the biopharmaceutical industry regarding how FDA review timelines and the approval process are being impacted by new requirements, such as REMS--Risk Evaluation and Mitigation Strategies. What our research provides is a real-world, metrics-based assessment to help inform expectations of new drug review outcomes in the Safety First Era," said Mark Mathieu, Director of Strategic Research at PAREXEL Consulting and the study's lead author.

The study findings link the implementation of the Food and Drug Administration Amendments Act (FDAAA), as well as FDA's workload and staffing-related challenges, to user-fee review time targets, which were not met for 17% of the Fiscal Year 2008 New Drug Applications** (NDAs), and 36% of the priority-rated NDAs. PAREXEL Consulting's analysis also indicates that although priority-rated NDAs continue to gain first-cycle approval at a higher rate than standard submissions, they dipped to 50% for the Fiscal Year 2008 cohort, down from a record 70% in 2007. Furthermore, data indicate that FDA granted priority status to 20% of NDAs submitted from fiscal 2006 to 2008, down from 30% in 2005, suggesting that this designation is increasingly difficult to obtain.

"Despite the recent decrease in first-cycle approval rates and increase in overdue reviews for priority NDAs, we believe that there remains powerful evidence in our study to support what PAREXEL Consulting calls the "The Innovation Imperative"--the concept that the most innovative new drugs stand to receive greater regulatory attention and more rapid marketing approval," said Alberto Grignolo, Ph.D., Corporate Vice President, Global Strategy Services, PAREXEL Consulting. "Our analysis shows that pursuing priority review status and submitting quality NDAs that can be approved on the first review cycle should continue to be carefully considered by pharmaceutical companies when seeking FDA approval for new drugs and earlier launch dates."

Further supporting "The Innovation Imperative" are PAREXEL's findings in regard to New Molecular Entity (NME) approvals. The PAREXEL Consulting study shows that among the NMEs approved by FDA in the first five months of 2009, priority-rated NMEs were cleared 13.3 months faster than standard-rated NMEs.