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PAREXEL Consulting Releases Annual Analysis of FDA New Drug Review Trends
Date:10/26/2010

 "The notable decline in first-cycle approvals for priority-rated drugs comes at a time when the FDA is implementing FDAAA requirements, in particular for Risk Evaluation and Mitigation Strategies, or REMS, which are particularly relevant for priority-rated therapies."

PAREXEL Consulting's analysis reveals that there are other factors pointing to a "new normal."  "The FDA's 13 percent priority designation rate for 2009 new drug applications mirrors the low rate at which some health care plans and other payers are finding value in newly approved drugs.  This illustrates the need for companies to take into account market-based clinical concerns in the product development process," according to Charles A. Stevens, Vice President and General Manager, Reimbursement and Market Access, PAREXEL Consulting.

Despite these trends, PAREXEL Consulting's analysis indicates that there are significant rewards for innovation in the context of the FDA review process.  For instance, despite the decrease in first-cycle approval rates for the class, the analysis shows that priority drugs continue to be approved more often and more quickly in the initial FDA review cycle.  According to the white paper, there is continuing evidence of a widening post-submission advantage for priority drugs.

"Our latest analysis provides strong evidence to further support what PAREXEL Consulting calls 'The Innovation Imperative,' which is the concept that the most innovative new drugs can reap advantages in critical regulatory and reimbursement reviews. These advantages include shorter, more predictable review times for drugs with priority ratings," said Alberto Grignolo, Ph.D., Corporate Vice President, Global Strategy Services, PAREXEL Consulting.  "We believe that over time new drugs will be expected to clear a progressively higher bar of innovation, a
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SOURCE PAREXEL International Corporation
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