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Introductions to recent updates to the regulations and the impact of FDAAA and FDASIA on the review process?. Partha Roy, Ph.D. | April 23, 2013. Outline. Evolution of PDUFA FDASIA Implementation User Fees: PDUFA, GDUFA, BSUFA Impact of 3 UFAs on Review Pediatric Drug Development

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slide1

Introductions to recent updates to the regulations and the impact of FDAAA and FDASIA on the review process?

Partha Roy, Ph.D. | April 23, 2013

outline
Outline
  • Evolution of PDUFA
  • FDASIA Implementation
    • User Fees: PDUFA, GDUFA, BSUFA
    • Impact of 3 UFAs on Review
    • Pediatric Drug Development
    • Breakthrough Therapies
    • GAIN Act
    • Increased Patient Participation in Medical Product
  • Revisiting FDAAA
    • Sentinel Initiative
a tale of three ufas
A Tale of Three UFAs…………….
  • Prescription Drug User Fee Act (PDUFA)
  • Generic Drug User Fee Amendments (GDUFA)
  • BioSimilarUser Fee Act (BSUFA)
    • Each with specific programmatic details
    • Aim to keep review work on sound financial footing
    • Focus on public health mission
    • Focus on public transparency
evolution of p rescription d rug u ser f ee act pdufa
Evolution of Prescription Drug User Fee Act (PDUFA)
  • PDUFA 1 (1992): US Congress gave FDA the authority to collect fees to support the process for the review of human drug applications, specifically to diminish the backlog of new drug applications at FDA and shorten review time
  • PDUFA II (1997): expanded the scope to include activities related to the IND period and to increase FDA communications with industry and consumer groups.
  • PDUFA III (2002): expanded the scope to include both preclinical development and a 3-year post-approval period.
  • PDUFA IV (2007) authorized under FDA Amendments Act (FDAAA): concentrated on new measures concerning post-market drug safety
  • ………And now in 2012, PDUFA V reauthorized under Food Drug Administration Safety Innovation Act (FDASIA) through September 30, 2017.
direct impact of pdufa on review time
Direct Impact of PDUFA on Review Time

Source: FDA CDER Data as of November 30, 2011, from John Jenkins, OND Director: “CDER New Drug Review: 2011 Update,” at FDA/CMS Summit, Dec 8, 2011

pdufa v
PDUFA V

Impact on Review

review timelines
Review Timelines

Previous NDA/BLA Review Timelines for all NDAs

New PDUFA V Review Timelines for NME NDAs and original BLAs

Approval

Filing

Review Process

6-10 Months Total

NDA Submission

Complete

Response Letter

Withdrawal

by Applicant

  • 6 Months (priority)
  • 10 Months (standard)

Approval

Filing

Review Process

8-12 Months Total

NDA Submission

Complete Response Letter

Withdrawal by Applicant

  • 6 Months (priority)
  • 10 Months (standard)

60 Days

(all NMEs/BLAs)

review model the program
Review Model – “the Program”
  • Applies to all NME NDA/BLAs
  • To promote greater transparency and improve communication between FDA’s review teams and applicants
  • To improve the efficiency and effectiveness of the first cycle review process
  • Decrease the number of review cycles needed for approval
  • Will be evaluated by an independent contractor with expertise in assessing the quality and efficiency of biopharmaceutical development and regulatory review programs
fda interactions during review
FDA Interactions during review

Sponsor - FDA meeting ≥ 2 months prior to submission

Internal to FDA

Sponsor - FDA meeting ≥ 3 months (standard review) and ≥ 2 months (priority review) of PDUFA

goal date

Phone call to Sponsor ≤ 2 weeks following meeting

review model
Review Model
  • Pre-submission meetings
  • Not less than 2 months prior to submission
  • May reach agreement to submit limited number of components not later than 30 days after the original NDA
  • Such components would not be expected to materially impact ability to begin the review
  • Examples:
  • Updated stability, Final audited nonclinical report
day 74 letter
Day 74 Letter
  • Communicate review issues
  • Planned review timeline, includes target date for feedback regarding proposed labeling, post-marketing requirements/commitments
  • Include the date for an internal mid-cycle review meeting (internal FDA meeting)
  • Preliminary plans re Advisory Committee
mid cycle communication
Mid-Cycle communication
  • Cross Discipline Team Leader (CDTL) will call applicant , generally within 2 weeks of meeting, to provide update on status of review
      • Significant issues
      • Information requests
      • Major safety concerns (thoughts re Risk Management)
      • Advisory Committee
      • Date for late cycle review meeting
discipline review dr letters
Discipline Review (DR) Letters
  • FDA intends to complete primary and secondary reviews and issue letters in advance of the planned late-cycle meeting
  • If DR letters not issued, issues will be communicated in brief memo as part of the Agency briefing package for the late cycle review meeting
late cycle meeting topics
Late-Cycle Meeting - Topics

Meeting held with the sponsor

  • Major deficiencies
  • Advisory Committee topics
  • REMS or Risk Management
  • Information Requests
  • Data or analyses sponsor may wish to submit, and whether such data would be reviewed in current review cycle
late cycle meeting
Late-Cycle Meeting
  • Occurs > 3 months (standard review) and > 2 months (priority review) prior to the PDUFA goal date
  • Agency briefing package

-Sent to applicant > 12 days before the meeting

-Contents

        • DR letters
        • Assessment of Risk Management
        • Brief memorandum of substantive application issues
late cycle meeting with advisory committee
Late-Cycle Meeting with Advisory Committee
  • Occurs > 12 days before the AC
  • AC to occur >3 months (standard review) and > 2 months (priority review) prior to the PDUFA goal date
  • Agency briefing package

-Sent to applicant > 20 days before the AC

-Contents

        • AC Briefing package
        • DR letters, Risk Mgt, memo of substantive issues
        • Potential questions/topics for AC
meeting management goals
Meeting Management Goals

Revised draft Guidance end FY2013

  • Type A meetings scheduled within 14 days;

To occur within 30 days

  • Type B or C meetings scheduled within 21 days;

Type B to occur within 60 days, Type C 75 days

  • Meetings re REMS or postmarketing requirements shall be Type B meetings
  • Post-Action meetings (requested within 3 months of action) shall be classified Type A meetings
enhancing regulatory science and expediting drug development
Enhancing Regulatory Science and Expediting Drug Development
  • Communication and Training staff (end FY2013)
  • Dedicated liaison staff

-Point of contact for general questions or clarification on which Division to contact for questions

-Secondary point of contact for sponsors who are encountering problems in communication with the review teams on INDs

  • Draft Guidance 2Q2015
gdufa
GDUFA

Impact on Generic Drug Development and FDA Review

gdufa overview and impact on generic industry
GDUFA Overview and Impact on Generic Industry
  • Generic Industry is large and fragmented
  • Made‐up of manufacturers of final dosage form (FDF) and active pharmaceutical ingredient (API) (approximately 95% of the ANDAs reference a DMF for the API)
  • Thousands of firms spread world‐wide
  • Generic firms usually work on a smaller budget than the innovators
  • Being first to file (Paragraph IV) and receiving a 180 day exclusivity is very important for generics
slide25
Increase in Foreign Inspection with Respect to Active Pharmaceutical Ingredient (API) and Final Dosage Form (FDF)

Source: Generic Drug User Fee Amendments of 2012 , Russell Wesdyk, FDA, OPS, (http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm)

does gdufa capable of addressing the u nprecedented regulatory c hallenges
Does GDUFA capable of addressing the unprecedented regulatory challenges?
  • $299MM per year is less than 1.5% of Generic Drug sales
  • Expected to reduce costs considering the improvement in the submissions proposed and reduced regulatory timelines
  • Doubling in OGD staff over the life of the program
  • Efficiency enhancement is a critical component of GDUFA
  • GDUFA is Modest Size Despite 10 X Plus the application volume of Brands
outlines of the agreement
Outlines of the Agreement
  • Funding level = inflation adjusted $299M/year
  • Application Fees
      • Applications in the backlog (year 1 only) of $50M
      • Drug master file fee (and availability for reference list)
      • ANDA and prior approval supplement (PAS) filing fee
  • Facility Fees
      • Involved in manufacture of generic drugs, whether API or FDF, domestic or foreign
  • Individual fees calculated/published
  • Fees not linked to types of services; rather overall goals
type of fees
Type of Fees
  • For fiscal year 2013, $50M will be derived from backlog and $249M will be charged for ANDAs, DMFs and Establishments.
  • For fiscal year 2014-2017, $299M will be charged for ANDAs, DMFs and Establishment
  • Division of fees
    • 6% from DMF reviews
    • 24% for ANDA original and prior approval supplement (PAS)
    • 56% for inspection of facility related to FDF manufacturing
    • 14% for API facilities
some significant changes due to gdufa to anda and dmf review process
Some Significant Changes Due to GDUFA to ANDA and DMF Review Process
  • Complete Response letters rather than discipline specific letters to the ANDA holders and DMF holders
  • Telephone information requests to address easily correctable deficiencies in ANDAs and DMFs during the review process before and after issuance of complete response letters
  • When requested by the ANDA sponsor or DMF holder within 10 business days of FDA issuing a first cycle complete response letter, FDA will grant a 30 minute teleconference to clarify issues and answer questions. Priority for such teleconferences will be given to expedited and first major amendment applications.
some significant changes due to gdufa to the anda and dmf review p rocess continued
Some Significant Changes Due to GDUFA to the ANDA and DMF Review Process (continued)
  • DMFs, which pay a one time fee, will undergo a completeness assessment (draft guidance published)
  • The DMFs that pay the GDUFA fee and are deemed “complete” will be placed in a publicly available database at the FDA website, http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm
  • During the approval of the ANDA, FDA will issue the DMF holder API, a letter to indicate that the DMF does not have any further open matters as part of the review associated with the referencing ANDA (not an approval or even “adequacy” letter. The status of DMF can change with any amendment)
some significant changes due to gdufa to the anda and dmf review process continued
Some Significant Changes Due to GDUFA to the ANDA and DMF Review Process (continued)

Firms will self identify following facilities:

  • Facilities that manufacture, or intend to manufacture, human generic drug APIs or FDFs, or both*
  • Sites and organizations that package the FDF primary container/ closure system and label the primary container/closure system.
  • Sites that are identified for repackaging from one primary container to another.
  • Bioequivalence (BE)/bioavailability (BA) sites that are identified in a generic drug submission

* Only these sites will pay the annual facility fees, except for the sites and organizations involved in manufacturing of PET products

some significant changes due to gdufa to the anda and dmf review process continued1
Some Significant Changes Due to GDUFA to the ANDA and DMF Review Process (continued)
  • Failure to self identify a facility and pay fees will lead to the FDF and/or API being considered misbranded and be in an arrears list.
  • FDA will employ a risk-adjusted biennial CGMP surveillance inspection model for inspection of generic API and FDF manufacturers
  • FDA will make inspection classification results and date of the last facility inspection available to the public and industry on FDA’s website on timely basis.
  • During the five years of the program, FDA will undertake a study of foreign government regulator inspections(CGMP and bioequivalence), report findings publicly, and develop a program to utilize foreign inspection classifications when and where appropriate.
goals and metrics based on gdufa of anda original and pas
Goals and Metrics based on GDUFA of ANDA (original) and PAS

Original (complete) ANDA Review and PAS reviews (this implies first complete response and may not be an approval)

  • 60% of submissions within 15 months for FY 2015 receipts
  • 75% of submissions within 15 months for FY 2016 receipts
      • 90% of submissions within 10 months for FY 2017 receipts
goals and metrics based on gdufa of anda original and pas continued
Goals and Metrics based on GDUFA of ANDA (original) and PAS (continued)

PAS (No Inspection Required)

  • 60% of submissions within 6 months for FY 2015 receipts
  • 75% of submissions within 6 months for FY 2016 receipts
  • 90% of submissions within 6 months for FY 2017 receipts

PAS (Inspection Required)

  • 60% of submissions within 10 months for FY 2015 receipts
  • 75% of submissions within 10 months for FY 2016 receipts
  • 90% of submissions within 10 months for FY 2017 receipts
goals and metrics based on gdufa for inspection and backlog
Goals and Metrics based on GDUFA for Inspection and Backlog

Inspection Metrics

Risk-adjusted surveillance inspection

  • Achieving biennial inspection rate and parity of foreign and domestic frequency in FY2017
  • Pre-approval inspections (PAIs) continue

Backlog Metrics

Review and act on 90% of backlog applications pending on Oct. 1, 2012, by end of FY 2017 (current backlog is ~2700 applications, original and supplements)

changes in ogd based on introduction of gdufa
Changes in OGD based on introduction of GDUFA

Significant changes:

  • OGD is on the way to becoming a super office directly under CDER
  • The CMC discipline is going to be separate under a new office, the Office of Pharmaceutical Quality (OPQ) with the ONDQA
  • This will assure a higher consistency of the review of the CMC sections of new chemical entities as well as generics
changes in ogd based on introduction of gdufa1
Changes in OGD based on introduction of GDUFA
  • A new DMF Review Division dedicated to review of Type II DMFs for APIs
  • A new team to review CBE-0 and CBE-30 supplements
  • Introduction of QbD for the final dosage form (FDF)
  • Improving the quality of DMF submissions through introduction of non-mandatory QbR for Type II DMFs for APIs in near future (Type II DMFs only referenced by NDAs do not need to submit this)
  • Increased communication with industry through publications, presentations
bsufa
BSUFA

Impact on Biosimilar Drug Development and FDA Review

bsufa f ees to support fda s biosimilar product development bpd and review p rogram activities
BSUFA: Fees to support FDA’s Biosimilar Product Development(BPD) and Review Program activities
  • The Biosimilar User Fee Act of 2012 (BSUFA) authorizes FDA to assess and collect fees for biosimilar biological products from October 2012 through September 2017
    • Fees support FDA’s biosimilar review program activities
    • BsUFAfee rates are set equal to PDUFA fee rates for applications, supplements, establishments, and products
    • BSUFA also includes biosimilar biological product development (BPD) fees for products in the development phase.
      • When a sponsor submits a biosimilar biological product application for a product, the fee for the application is reduced by the cumulative amount of previously paid BPD fees for the product
  • FDA committed to review performance goals under BsUFA
    • BsUFAgoal types are similar to the PDUFA goal types, with some differences in timeframes
    • Under the BSUFA program, there are five types of formal meetings that can occur between sponsors and FDA staff to discuss biosimilar development programs
bpd fees intended for products in development
BPD fees intended for products in development
  • BPD fees include the initial BPD fee, the annual BPD fee, and the reactivation fee
  • The BPD fee is an annual per-product fee, not a per-meeting or per-review activity fee
    • A sponsor must pay an initial BPD fee for a product to participate in FDA’s BPD Program for that product
    • Once a sponsor has paid the initial BPD fee for a product, beginning in the next fiscal year, FDA will assess an annual BPD fee for the product until the sponsor submits a biosimilar biological product application for that product that is accepted for filing, or discontinues participation in the BPD Program for that product
    • If a sponsor has discontinued participation in the BPD Program for a product and wants to again engage with FDA on development of the product as a biosimilar product, the sponsor must pay a reactivation fee to resume participation in the BPD Program for that product
  • BPD fees are not assessed for a product after the biosimilar biological product application is filed
slide42

Meetings provide key opportunities to keep biosimilar development programs on track

Christl, 2012

fdasia
FDASIA

Pediatric Drug Development

pediatric drug development new provisions under fdasia 2012
Pediatric Drug Development: New provisions under FDASIA 2012
  • New requirements for Pediatric Study Plans
  • Provision for extension for deferred studies
  • Neonates and the Written Request
  • Pediatric Priority Review Voucher
pediatric regulatory history in us
Pediatric Regulatory History in US

Source: Adopted from Melissa S. Tassinari, Pediatric and Maternal Health Staff, OND, CDER, Dec 4, 2012

changes under fdasia
Changes under FDASIA
  • Pediatric Study Plans – PSPs
      • Sponsors required to submit plans at End of Phase 2
  • Must include:
      • Outline of the pediatric study or studies that the applicant plans to conduct (including, to the extent practicable study objectives and design, age groups, relevant endpoints, and statistical approach)
      • Any request for a deferral, partial waiver or waiver, along with supporting information
pediatric p lan within overall drug development
Pediatric Plan within Overall Drug Development

WR issued (BPCA)

PSP

Agreed PREA

requirements

EOP2

PSP modifications

Approval

Source: Adopted from Melissa S. Tassinari, Pediatric and Maternal Health Staff, OND, CDER, Dec 4, 2012

pediatric study plan should include
Pediatric Study Plan should include……
  • Overview of the disease in the pediatric population for the product under development
  • Potential plans and justification for use of extrapolation
  • Plans and justification for full or partial waiver
  • Plans for pediatric specific formulation development
  • Nonclinical data, complete or planned, to support studies in children
  • Synopsis/summary of all clinical studies planned
  • Timeline for the Pediatric Study Plan
  • Provide any agreements with other Health Authorities (e.g., PIP for EMA)
review timeline
Review Timeline
  • Submit initial PSP within 60 days of EOP2 meeting
  • Review Division and PeRC must review this PSP within 90 days
  • Review Division must discuss the initial PSP with Sponsor by day 90 (meeting or written comments)
  • Sponsor must incorporate recommendations and submit “Agreed Initial PSP” within 90 days from the meeting
  • PeRCmust review “Agreed Initial PSP” within 30 days of submission of Agreed Initial PSP
  • Letter to confirm agreement with “Agreed Initial PSP” must be sent to sponsor within 30 days of submission of Agreed Initial PSP
new provision for prea under fdasia
New Provision for PREA under FDASIA
  • To allow extension for deferred studies under PREA
  • General criteria for acceptance of extension requests
    • Provide general consistency with reasons for delayed FDAAA Post Marketing Requirements [PMRs]
    • Delay in development could not have been prevented or could not have been foreseen
    • Sponsor will still be able to complete the studies
written request wr and the fdasia
Written Request (WR) and the FDASIA
  • No change in the process
    • PPSR submitted by the sponsor or WR generated by the FDA
  • Inclusion of neonates (birth – 28 days)
    • All age groups must be considered and included where appropriate
    • If inclusion of neonates is not warranted a justification must appear in the WR
      • Disease does not occur in this age group
      • Studies are not feasible or safe
pediatric priority review voucher
Pediatric Priority Review Voucher
  • For development of products for rare pediatric disease
  • Provides a voucher for ‘priority review’ of any subsequent application
    • A rare pediatric disease is defined as “disease that primarily affects individuals aged from birth to 18 years, including age groups often called neonates infants, children and adolescents” AND meets the definition of ‘rare disease or condition’ as set forth in the Orphan Drug Act
  • PPR voucher granted if
    • Meet above definition
    • Provide clinical data from studies in the intended pediatric population – including dosing information
    • Not seeking approval for an adult indication in the original rare pediatric disease product application
gain act
GAIN ACT
  • Generating Antibiotic Incentives Now (GAIN)
  • FDASIA provides 5-years of exclusivity for approval of certain antibacterials & antifungals
  • “Qualifying Infectious Disease Product”
    • Targets serious or life-threatening pathogens
    • Eligible for Fast Track and Priority Review
    • Designation ongoing
  • Part 15 Hearing Dec 18, 2012 seeking input on the list of qualifying pathogens
fdasia innovation breakthrough therapy designation
FDASIA “Innovation”: Breakthrough Therapy Designation
  • Definition:
    • Aim of designation is to expedite development and review of these therapies
    • Intended, alone or in combination with one or more other drugs to treat a serious or life-threatening disease
    • Preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints
    • Substantial treatment effects observed early in clinical
    • Complements existing pathways: Fast Track, Priority Review and Accelerated Approval
  • Guidance under development to detail process: no later than 18 months after FDASIA implementation
expedited development clearing the confusion
Expedited Development: clearing the confusion…….
  • Fast Track Designation: intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
    • May be granted based on preclinical data
    • More frequent interactions with FDA
    • Rolling review
  • Accelerated Approval: speeding the development and approval of promising therapies that treat a serious or life-threatening condition and provide meaningful therapeutic benefit over available therapies.
    • Use of ‘surrogate endpoint’
    • Substantial post-marketing commitment, FDA can withdraw approval if post-marketing trials fail to verify the predicted clinical benefit
  • Priority Review:
    • Two-tiered system of review
    • Review goal date shortened to 6 months instead of 10 months standard review
breakthrough fda commitment dictated by fdasia
Breakthrough: FDA Commitment dictated by FDASIA
  • providing timely advice to, and interactive communication with, the sponsor to ensure that the development program is gathering the nonclinical and clinical data necessary for approval is as efficient as practicable
  • taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment
  • assigning a cross-disciplinary team leader (CDTL) for the FDA review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the cross-discipline members of the review team for coordinated internal interactions and communications with the sponsor through the review division’s Regulatory Health Project Manager
  • involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review
breakthrough therapy examples
Breakthrough Therapy: Examples
  • Vertex received the first 2 BT designations:
    • Kalydeco (ivacaftor), already approved for a small fraction (~4%) of cystic fibrosis patients 6 years and older who harbor a particular mutation in the CFTR gene known as G551D, for additional mutations of the CFTR protein
    • Combination of Kalydeco and experimental drug VX-809 received BT designations for CF patients with the most common type of CF mutation, known as F508del.
  • Palbociclib (PD-0332991) received BT designation, being investigated for the treatment of advanced breast cancer – Pfizer
  • Ibrutinib received three BT designations for three indications - :
    • Use in relapsed or refractory mantle cell lymphoma (MCL)
    • Waldenstrom’smacroglobulinemia (WM).
    • To treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with deletion of the short arm of chromosome 17
focus on patient participation in drug development process
Focus on Patient Participation in Drug Development Process
  • Patient Participation in Medical Product Discussions under FDASIA
    • Fostering participation of FDA Patient Representatives as Special Government Employees in appropriate agency meetings with medical product sponsors and investigators; and,
    • Exploring means to provide for identification of potential FDA Patient Representatives who do not have any, or have minimal, financial interest in the medical products industry.
  • Patient-Focused Drug Development under PDUFA V
    • More systematic and expansive approach to obtaining the patient perspective on disease severity or the unmet medical need in a therapeutic area to benefit the drug review process
      • 20 meetings over 5 years
    • Meeting October 5, 2012 to solicit input on preliminary list of disease areas and criteria used to select them
current fdaaa environment
Current FDAAA Environment

Food and Drug Administration Amendments Act of 2007 (FDAAA)

  • Provides FDA with additional requirements, authorities, and resources with regard to both pre- and post-market drug safety
    • New authorities to require post-market studies and clinical trials, safety labeling changes, and Risk Evaluation and Mitigation Strategies (REMS)
    • Increased activities for active post market risk identification and analysis
    • New reporting of adverse events related to food and new regulations for pet food labeling, ingredients, and processing standards
current fdaaa environment1
Current FDAAA Environment

FDAAA Implementation – Examples

  • Required post-marketing studies, or clinical trials to address safety issues; post-marketing commitments now required (previously voluntary) and established timeframes are enforceable
  • Required safety label changes
  • Can require REMS to ensure that the benefits of a drug outweigh its risks
  • Sentinel Initiative (launched May 08):
    • Create and implement a nation-wide active, electronic surveillance system for monitoring medical product safety
    • Develop methods to obtain access to disparate data sources and to establish a post-market risk identification and analysis system
    • Requires FDA to work closely with partners from public, academic, and private entities
mini sentinel tool
Mini-Sentinel Tool
  • Mini-Sentinel tool developed in 2011 to rapidly access and query quality-checked data
      • Query results available in weeks not months/years
      • To date 290 queries conducted
      • Results facilitating regulatory decision-making
  • Federal Partner’s Collaboration
      • Medicare program data
      • VA data
questions
Questions?

Thank you