• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

For Industry

  • Print
  • Share
  • E-mail

APPENDIX A: GRMPS IMPLEMENTATION STATUS: Independent Evaluation of FDA's First Cycle Review Performance – Final Report

Table of Contents

RECOMMENDATIONS

GRMPs implementation began with the publication of guidance in April 2005 and is still continuing.  Given this timing, only applications reviewed in the Prospective Analysis Cohort (FY2005-FY2007) were considered in measuring GRMPs compliance.  


 GRMPs Compliance Baseline

A baseline level for GRMPs implementation was collected through interviews with Division Directors and review staff held in January 2006.  Changes in GRMPs adoption were assessed over time as each product in the Prospective Analysis Cohort was reviewed (FY2005-FY2007).  Interview data was required because many of the GRMPs steps do not result in documentation that can be analyzed.  The baseline assessment of FDA’s practices could be used to assess future levels of improvement in compliance (Exhibit 49). The baseline analysis showed that while the majority of GRMPs activities were adhered to, FDA Divisions were challenged to consistently meet timelines after the filing and review planning phase.  FDA interviewees cited insufficient staffing to address the review workload as a primary factor in failure to meet GRMPs deadlines.

Exhibit 49. Baseline of GRMPs Practices Adopted by Divisions – January 2006 Snapshot

Chart of Baseline of GRMPs Practices Adopted by Divisions – January 2006 Snapshot


GRMPs Compliance for FY 2005 to FY 2007 Products

A product-by-product assessment of GRMPs adoption for the FY05 to FY07 cohort showed GRMPs adoption progressed at different rates across offices. For this cohort, 20% of the reviews (17 of 85) complied with 80% or more of the five assessed activities (Exhibit 50). [21] More than half (56%) of the reviews of products in the cohort complied with two or less of the measured activities [22].

Exhibit 50. GRMPs Compliance by Product

Chart of GRMPs Compliance by Product

Most offices had started implementing GRMPs.  However, the extent to which they had implemented them varies considerably.  One office was highly compliant with 57% of its reviews.  Of the remaining offices, high GRMPs compliance was not achieved with more than 25% of the application reviews (Exhibit 51).

Exhibit 51.  CDER and CBER GRMPs Compliance by Office

Chart of CDER and CBER GRMPs Compliance by Office

Improvement in compliance was analyzed for the period following GRMPs rollout (FY 2005- FY 2007).  As GRMPs were developed from existing best practices in offices, some offices had high levels of initial compliance with activities.  Compliance with GRMPs activities in the Review Phase increased substantially between FY05 and FY07.  Mid-cycle meetings were conducted on time for just 8% of reviews in FY05, but for 63% of reviews in FY07 (Exhibit 52).  Completion of the primary clinical review within the specified timeline also improved, from 16% in FY05 to 38% in FY07.

Exhibit 52. GRMPs Compliance in Review Phase

Chart of GRMPs Compliance in Review Phase

Yet, compliance with measured GRMPs activities in the filing and action phases had remained constant throughout the three-year period.  Compliance with sending out the 74-Day letter was consistently over 90% throughout the assessed time period (Exhibit 53).  The filing meeting was held within the specified timeline for approximately 60% of applications throughout the cohort period.  Similarly, labeling discussions took place during the action phase in approximately 45% of application reviews in each of the three years.

Exhibit 53. GRMPs Compliance in Filing and Action Phases

Chart of GRMPs Compliance in Filing and Action Phases


APPENDIX B: SPONSOR AND FDA FOCUS GROUP FINDINGS