PAREXEL's white paper provides data on biopharmaceutical, medical device product development

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 a new white paper entitled Drug Innovation, Approval, Market Access, and the "New Normal": Emerging FDA Review Outcome Trends for New Drugs.  Exploring trends in the review of new molecular entities (NMEs), as well as first-cycle approval and priority designation rates, PAREXEL Consulting's analysis indicates that there is a "new normal" emerging in the drug review and approval process.

PAREXEL Consulting's analysis identified notable declines in both first-cycle approval rates for priority drug applications and priority designation rates for new drugs at the time when the U.S. Food and Drug Administration (FDA) settled into its FDA Amendments Act (FDAAA)-related responsibilities and the 21st Century Review Process.  Between 2008 and 2009, for example, PAREXEL Consulting found that there was a 25 percent decline in first-cycle approval rates for priority-rated new drugs and a 17 percent decrease in priority designations for new drug applications (NDAs).

"First-cycle approval rates are a key indicator of the biopharmaceutical industry's success in securing FDA approval for new therapies early in the review process.  While there is often some fluctuation in first-cycle approval rates year-to-year, our analysis of the latest FDA metrics leads us to ask whether there is a 'new normal' emerging, which has significant implications for the drug-review process," said Mark Mathieu, Director of Strategic Research at PAREXEL Consulting.  "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, and actually deliver a more significant benefit than previously approved drugs in the same therapeutic class.  As a result, true innovation is becoming part of the 'new normal.'"

The white paper, part of PAREXEL Consulting's Intelligent Development Series, which provides data and insights in support of successful biopharmaceutical and medical device product development, is available at: https://www.parexel.com/.