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FDA AA - Title I. PDUFA IV & FDA’s Performance Goals Friday, 30 November 2007 MBC Naseem Kabir Associate Director Regulatory Affairs. FDAAA & FDA’s PERFORMANCE GOALS. PDUFA IV (Parts I-VII): What is New?. FDA’s fee revenue amounts have increased. PDUFA IV (Parts I-VII): What is New?.

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fda aa title i

FDA AA - Title I

PDUFA IV & FDA’s Performance Goals

Friday, 30 November 2007


Naseem Kabir

Associate Director

Regulatory Affairs

pdufa iv parts i vii what is new
PDUFA IV (Parts I-VII): What is New?

FDA’s fee revenue amounts have increased

pdufa iv parts i vii what is new4
PDUFA IV (Parts I-VII): What is New?
  • Additional $225 million of revenues for drug safety reflected in user fees
    • $25,000,000 for fiscal year 2008;
    • $35,000,000 for fiscal year 2009;
    • $45,000,000 for fiscal year 2010;
    • $55,000,000 for fiscal year 2011; and
    • $65,000,000 for fiscal year 2012
pdufa iv parts i vii what is new5
PDUFA IV (Parts I-VII): What is New?
  • Additional criteria for orphan drugs to request exemption from product and establishment fees
    • The drug is owned / licensed and is marketed by a company that had less than $50,000,000 in gross worldwide revenue during the previous year
      • Must submit certification that gross annual revenues < $50,000,000 for the preceding 12 months before the exemption was requested
pdufa iv parts i vii what remained the same
PDUFA IV (Parts I-VII): What Remained the Same?
  • FDA’s performance goals for application reviews
  • Orphan drugs continue to remain exempt from user fees for review of applications
  • Performance goals for clinical holds, major dispute resolution and SPAs
  • Requirement to pay annual prescription drug establishment fees and product fees
pdufa iv parts i vii what remained the same7
PDUFA IV (Parts I-VII): What Remained the Same?

Original & Resubmitted NDAs/BLAs & Efficacy Supplements

Manufacturing Supplements

pdufa iv parts i vii what changed slightly
PDUFA IV (Parts I-VII): What Changed Slightly?
  • An application/supplement that is submitted but refused for filing, or withdrawn before being accepted/refused for filing is subject to full review fee upon resubmission (unless waived/reduced)
  • FDA’s performance goals for meeting management remain unchanged except:
    • Type B and C: 90% within 21 calendar days of FDA receipt
part viii enhancement and modernization of the fda drug safety system
Part VIII: Enhancement and Modernization of the FDA Drug Safety System

FDA to develop a 5-year plan to modernize drug safety activities & systems, emphasizing:

  • new methodologies in the collection of AE info throughout the product life cycle;
  • epidemiology best practices and guidances;
  • CDER/CBER database acquisition and expansion;
  • validation, development of risk management / communication tools;
  • improved post-market IT systems / linkages, and
  • enhanced coordination between FDA offices and teams (CDER and CBER, pre-market and post-market)
part viii enhancement and modernization of the fda drug safety system11
Part VIII: Enhancement and Modernization of the FDA Drug Safety System

FDA will conduct and support activities designed to modernize PV by:

  • Maximizing public health benefit of AE collection throughout product life cycle
    • RFP published in 2008, awarded 2009, completed by 2011
    • Contractors will critically review US, ex-US AE collection

B. Developing an epidemiology ‘best practices’ and guidance document

    • Public workshop in 2008; review current practice in US, ex-US
    • CDER and CBER to release joint guidance in 2010
part viii enhancement and modernization of the fda drug safety system12
Part VIII: Enhancement and Modernization of the FDA Drug Safety System

FDA will conduct and support activities designed to modernize PV by: (cont..)

C. Expanding database resources

  • Not just AERS, but population-based epidemiologic data
  • Targeted PM surveillance, signal detection
  • FDA to purchase epi (observational) DB, hire additional epi staff

D. Developing, validating risk management and risk communication tools

  • Evaluate effectiveness of RiskMAPs
  • Public workshop in 2009: assess current risk management / risk communication options
  • Annual systematic review of select risk management programs & tools
part viii enhancement and modernization of the fda drug safety system13
Part VIII: Enhancement and Modernization of the FDA Drug Safety System
  • Impact on Industry:
    • Outcome of the 5-year plan is likely to bring about a dramatic shift in PV, with consequences to all PV processes and procedures
    • Increasing importance of risk management PE will impact resources, training, and necessary skill sets
    • PE will become increasingly critical to support PM safety activities and commitments
    • IT systems thus created will need to be updated to accommodate new requirements
    • PDUFA IV represents a significant shift towards a life-cycle approach to risk management
part ix review of proprietary names
  • Objective is to reduce medication errors
  • Opportunity to submit brand name during the IND process (instead of during NDA) and to obtain FDA feedback earlier
  • Pilot program to be implemented in FY 09
    • Allows companies to submit their research on the brand names, which FDA can evaluate to provide decision
part x first cycle review performance
PART X: First Cycle Review Performance

Day-74 Letters: Notification of Issues Identified During Filing

  • Will identify substantive review issues during the filing review (for original NDA/BLA applications and efficacy supplements)
  • Notification also sent if no substantive issues identified
  • Not indicative of deficiencies that may be identified later in the review cycle
  • To include planned review timelines (including dates for feedback on labeling and post-marketing commitment discussions)
    • Allows companies to better plan workload
    • Solid strategy on submission content
    • Submission of major amendments may nullify timelines
part xi expediting drug development
PART XI: Expediting Drug Development
  • FDA to develop guidance documents to further the Critical Path Initiative
    • Clinical Hepatotoxicity – FY 2008
    • Non-inferiority Trials – FY 2008
    • Adaptive Trial Designs – FY 2008
    • End of Phase 2(a) Meetings – FY 2008
    • Multiple Endpoints in Clinical Trials – FY 2009
    • Enriched Trial Designs – FY 2010
    • Imaging Stds for Use as an EP in Clinical Trials – FY 2011
  • Ongoing collaboration with scientific community to develop guidances on:
    • Predictive Toxicology
    • Biomarker Qualification
    • Missing Data
  • FDA participation in public workshops to explore new approaches to develop a structured model for benefit/risk assessment. Goal is to evaluate pilots and development of guidance documents
part xii post marketing study commitments
PART XII: Post-Marketing Study Commitments

FDA commits to:

  • Developing harmonized (CBER/CDER) SOPs that articulate the Agency’s policy and procedures (e.g., timing, content, rationale and vetting process) for requesting that applicants agree in writing to “voluntary post-marketing study commitments”
    • What will “voluntary” mean to industry?
  • SOPs will be finalized prior to the end of FY 08
  • Training will be provided to all CBER and CDER review staff on the SOPs as necessary through FY 12

From industry perspective:

  • Must strategically consider consequences of PMCs and negotiate accordingly
  • Part XII extends possibility of FDA requesting PMCs for previously approved drugs
part xiii improving fda performance management

FDA will conduct studies to:

  • Assess the impact of the electronic submission and review environment on the efficiency and effectiveness of the overall process for the review of human drugs
  • Assess the progress toward full implementation of Good Review Management Principles, focusing on both FDA reviewer practices and industry sponsor practices affecting successful implementation
part xiv it goals
Part XIV: IT Goals
  • 5-year plan will include:
    • new safety system (previously referred to under Drug Safety)
    • a roadmap for all IT plans intended to support the goal of end-to-end electronic communications
    • Plan will be updated as FDA deems necessary to achieve the IT objectives
  • Communications and Technical Interactions:
    • FDA and industry stakeholders will meet on a quarterly basis to discuss:
      • Discuss on-going implementation of the IT Plan
      • Status of IT metrics as available
      • Potential impacts of future activities on stakeholders
      • Revisions to the IT Plan
part xiv it goals20
Part XIV: IT Goals

Metrics & Measures

  • Numbers and types of applications received (NDA, BLA, IND, etc.)
  • Total number of submissions categorized by type of submission
  • Total number of submissions in valid electronic format in compliance with FDA standards
  • The number and type of failure areas for electronic submissions out of compliance
  • Total number of submissions received through the secure electronic single point of entry versus other methods
  • Total number of submissions received substantially on paper.
section b fees relating to advisory review of dtc tv ads

Overview of Legislation

  • Authorizes FDA to assess/collect user fees for advisory review of drug DTC TV ads
    • Medical device DTC TV ads not impacted at this time
  • Voluntary Program
    • Notify FDA in advance of # of DTC TV ads intended for next FY
    • FDA issued FR notice for companies wishing to participate in FY 2008
  • Legally binding commitment to pay fees
    • ≤$83,000 per submission in FY2008
    • to be paid up front for # of reviews requested
  • FDA will commit to providing advisory review in specified period of time
for further info
For Further Info

My contact info

[email protected]

FDAAA website


PDUFA website


FDA Performance Goals