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FDA AA - Title I
PDUFA IV & FDA’s Performance Goals
Friday, 30 November 2007
MBC
Naseem KabirAssociate Director
Regulatory Affairs
2
FDAAA & FDA’s PERFORMANCE GOALSFDAAA (Title I) Performance Goals
Section 103 (Authority to Assess & Use Drug Fees)
Section A
I. Review Performance Goals
II. NME Performance Goals
III. Meeting Management
IV. Clinical Holds
V. Major Dispute Resolution
VI. Special Protocol Assessments
VII. Additional Procedures
VIII. Enhancement and Modernization of the FDA Drug Safety System
IX. Review of Proprietary Names to Reduce Medication Errors
X. First Cycle Review Performance
XI. Expediting Drug Development
XII. Post-Marketing Study Commitments
XIII. Improving FDA Performance Management
XIV. Information Technology Goals
Section 104 (Fees Relating to Advisory Review of Prescription Drug TV Advertising)
Section B
Performance Goals & Procedures for Advisory Review of DTC Television Advertising
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PDUFA IV (Parts I-VII): What is New?
FDA’s fee revenue amounts have increased
Type of Fee Revenue Fiscal Year 2007 Fiscal Year 2008
Total Fee Revenue $259.3 million $392.7 million
Establishment $86.433 $153.137
Product $86.433 $153.137
Application/Supplement $86.434 $153.137
Drug Safety -- $25 million
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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
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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
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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
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PDUFA IV (Parts I-VII): What Remained the Same?
SUBMISSION COHORT Standard Priority
Original Applications 90% in 10m 90% in 6m
Class 1 Resubmissions 90% in 2m 90% in 2m
Class 2 Resubmissions 90% in 6m 90% in 6m
Original Efficacy Supplements
90% in 10m 90% in 6m
Class 1 Resubmitted Efficacy Supplements
90% in 2m 90% in 2m
Class 2 90% in 6m 90% in 6m
FY 2008-2012 90% in 6m (CBE) 90% in 4m (PAS)
Manufacturing Supplements
Original & Resubmitted NDAs/BLAs & Efficacy Supplements
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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
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PDUFA IV (Parts I-VII): What Changed Slightly?
Submission Type Fiscal year 2007 Fiscal year 2008
Applications
Requiring clinical data
Not requiring clinical data
Supplements requiring clinical data
Annual Establishment Fee
Annual Product Fee
896,200
448,100
448,100
331,100
49,750
1,178,000
589,000
589,000
392,700
65,030
User fee increases
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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:
A. new methodologies in the collection of AE info throughout the product life cycle;
B. epidemiology best practices and guidances;
C. CDER/CBER database acquisition and expansion;
D. validation, development of risk management / communication tools;
E. improved post-market IT systems / linkages, and
F. enhanced coordination between FDA offices and teams (CDER and CBER, pre-market and post-market)
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Part VIII: Enhancement and Modernization of the FDA Drug Safety System
FDA will conduct and support activities designed to modernize PV by:
A. 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
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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
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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
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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
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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
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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
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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
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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
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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
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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.
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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
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For Further Info
My contact [email protected]
FDAAA websitehttp://www.fda.gov/oc/initiatives/advance/fdaaa.html#actions
PDUFA websitehttp://www.fda.gov/oc/pdufa/
FDA Performance Goalshttp://www.fda.gov/oc/pdufa4/pdufa4goals.html
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Questions?