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Janssen Research _ Development - Delegate

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Janssen Research _ Development - Delegate Powered By Docstoc
					Contrast between EMA & FDA
An Industry Perspective
March 19-20, 2012
PTMG, Brussels 


Dorothy Linvill-Neal
Head, Global Trademark Development




                                     Global Strategic Marketing & Market Access
                                     Global Strategic Marketing & Market Access
Presentation Objectives
• Pharmaceutical Brand Name Goals
• Error definitions
• Rejection Rates
• TM Development Hurdles/Timelines/Process
• History/Chronology of FDA/EMA Regulatory Name Review
• Other Global Health Authority Reviews
• Comparison FDA/EMA
• Latest trends – New Guidance Documents
• Summary
• Q & A

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                                          Global Strategic Marketing & Market Access
                                          Global Strategic Marketing & Market Access
Pharmaceutical Branding

• Pharmaceutical/Device/Rx OTC branding presents unique 
  challenges versus typical consumer goods.

    Pharmaceutical Industry must strive to develop names that 
    balance Patient Safety & Marketing objectives. 




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                                         Global Strategic Marketing & Market Access
                                         Global Strategic Marketing & Market Access
Brand Name Goals
• A global name ready for regulatory review 2-3 
  years prior to product launch. 

• Global TM Uniformity/Traveler Safety

• The name must be:
    – Safe for Use in Healthcare Environment
    – Available from Legal perspective 
    – Available from Regulatory perspective
    – Acceptable to Medical Professionals and Patient Audiences
    – Appropriate/connected to Product 
    – Supported by the Product Team

3
                                          Global Strategic Marketing & Market Access
                                          Global Strategic Marketing & Market Access
Name Development:  Considerations

    Over 17,000 drug names currently marketed in the U.S.* 
    98% of all drug names have look-alike or sound-alike names* 

  50% of all medication errors are estimated 
due to confusingly similar drug names, 
labeling, or packaging *
  The FDA receives and reviews about 250 medication 
error reports each month*
          ISMP reported in 2011 that approx. 25 % of
          medication errors
           are linked to Trademarks that have similarity to
          other trademarks **
*Gerald Phillips, R.Ph, Director of the office of Post-marketing Drug Risk Assessment OPDRA) “FDA rejects roughly one-third
of drug names.“ Washington Drug Letter (June 4, 2001): Vol.33, No. 22

  **Institute for Safe Medication Practice 




                                                                                                 Global Strategic Marketing & Market Access
                                                                                                 Global Strategic Marketing & Market Access
Industry Challenges
Key Market Industry Name Rejection Rates


                       48% of all brand names submitted for EMA approval are rejected - 2011

                                                        Source: CHMP – December 2011
                                                        Summary

                       42% of all brand names submitted for FDA approval were rejected - 2010

                                  - Half of all rejections are Sound-a-like / Look-a-like
         Source: August 8, 2011   - Half of all rejections are Promotional        Source: June 2009 - DIA
         Pink Sheet                                                                 meeting



                       75% of all nonproprietary names submitted for WHO approval are rejected
                              Source: Sophia Fuerst, Former Consultant to the INN


                       80% of all nonproprietary names submitted for USAN approval are rejected



                                                               Global Strategic Marketing & Market Access
                                                               Global Strategic Marketing & Market Access
                              Hurdles to Global Trademark 
                              Clearance             
             GTD



      Competition
    Battle for
    brand      Legal Clearance
    uniqueness Struggle for
               availability
               & ownership  Internal Buy-In
               Enforcement  Gain consensus
                            Overcome
                            Subjectivity   Regulatory
                                                             FDA/EMEA
                                                             nomenclature review
*Trademarks distinguish                                      Health Canada
 goods and services from those manufactured                  Mexican Health Ministry
 or sold by others.. Unlike patents TMs are forever          Brazil/S.Africa/Russia
With continued use in commerce                               Japan/Australia

                                                      Global Strategic Marketing & Market Access
                                                      Global Strategic Marketing & Market Access
HA vs. PTO Review

Objective of Regulatory           Objective of Legal TM

• Name Review is protection       • Review is obtain legal 
  of public health based on         protection
  safety criteria                 • Likelihood of Confusion
• Inadvertent substitution



    * Therefore, results of both important analysis need to be 
       considered in selecting appropriate name candidates

        * Consistency in opinion is not always guaranteed


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                                         Global Strategic Marketing & Market Access
Standards of Review – Differing 
Approaches

USPTO/CTM-OHIM                              FDA/EMA

• Review practices designed for             • Review procedures built with 
  trademarks across all industries            pharmaceutical industry in mind 
                                              (NDAs, BLAs, aNDAs)
• Focuses on likelihood of confusion  
  (similarity/commercial relationship)      • Focuses on health and 
                                              safety/Inadvertent substitution
• Priority based on first to file or use 
  (regardless of registration date)         • Priority based on first approved 
                                              (regardless of filing date at 
• Review conducted by attorneys               USPTO/CM)
  who only review registered 
  trademarks and pending                    • Trainwreck Scenario
  applications
                                            • Review conducted by medical 
                                              specialists, who gather empirical 
                                              evidence about the marketplace

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                                                     Global Strategic Marketing & Market Access
                                                     Global Strategic Marketing & Market Access
    Medication Error
Medication Errors
üAny  PREVENTABLE  event  that  may  cause  or  lead 
 to  inappropriate  medication  use  or  patient  harm, 
 while the medication is in the control of the health 
 care professional, patient or consumer




                               9
                                   Global Strategic Marketing & Market Access
                                   Global Strategic Marketing & Market Access
What name is this?




        (this is a reproduction of the actual prescription)




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                                            Global Strategic Marketing & Market Access
                                            Global Strategic Marketing & Market Access
Misprescription


     The classic example:


          AVANDIA or COUMADIN
     Seen side-by-side, they are very different.

 From a trademark and phonetic perspective, 
 there is no problem.
 But HANDWRITTEN!!




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                                        Global Strategic Marketing & Market Access
                                        Global Strategic Marketing & Market Access
Handwriting a Concern



  AV A N DI A




  (this is a reproduction of the actual prescription)
   C O U MA D I N




                                   Global Strategic Marketing & Market Access
                                   Global Strategic Marketing & Market Access
FDA – EMA      Name Safety                Pharmaceutical 
               Consultants                   Industry
Other HA’s     Patient Safety 
                 Advocates




               Minimize
              Medication
                Errors


      Stakeholders – A Common Goal



                                 Global Strategic Marketing & Market Access
                                 Global Strategic Marketing & Market Access   13
  TM REJECTION RATES !!!
             YEAR*                    FDA DMEPA/DMETS               EMA CHMP NRG
               2002                               31%                           30%
               2003                               29%                           33%
               2004                               36%                           34%
               2005                              35-40%                         49%
               2006                              33%est.                        48%
               2007                              33%est.                        47%
               2008                               36%                           43%


               2009                               38%                           51%
               2010                               39%                           55%
               2011                               42%                           48%

*Many drugs are on critical approval path with             * NOTE: FDA data are for 
Limited time on submission clock                           Fiscal Years; EMA data, Calendar 
                                                           Years
                                                             Global Strategic Marketing & Market Access
                                                             Global Strategic Marketing & Market Access
NRG — Invented Names Reviewed
2006 -2011                              2011 
                                        Reversal rate  41%
                                         39 rejustifications




    n=    n=    n=    n=    n=            n=
    348   366   311   516   374           687

                              Global Strategic Marketing & Market Access
                              Global Strategic Marketing & Market Access
Can you Avoid Rejection?


               GLOBAL BRAND!!
                           FDA
              PTO’
              s
                     EMA




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                            Global Strategic Marketing & Market Access
                            Global Strategic Marketing & Market Access
     Brand Name Development Process - Timeline


    Phase II                                        Phase III                        Approvals
                                                Legal Searching,
                                                Investigations,
                                                 filings

        -6
        -6               -5
                         -5              -4
                                         -4              -3
                                                         -3              -2
                                                                         -2                  -1
                                                                                             -1



        Non-                                                                                         Launch
                           Briefing
                                                 Years
  Proprietary
      Name      Strategy, Direction
Development
                                                                               Provisional
                                                                               Approval
                                                 Safety & Market                                  Final
                                                                               TM Use
 Up to 5 Year                                    Research                                         Regulatory
                               Create & Pre-screen                                                Reviews
 Process                                                   Company
                               Names                       Approval Preliminary
                                                                    Regulatory
                                                                    Reviews


                                                                   Global Strategic Marketing & Market Access
                                                                   Global Strategic Marketing & Market Access
History of Regulatory 
    Name Review 




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              Global Strategic Marketing & Market Access   18
  1999 - IOM — TO ERR IS HUMAN
Medication Errors - Very Revealing/Call
to Action
   • Using the wrong drug name, dosage form, or abbreviation 
         • 11.4 percent for both brand name and generic name orders
                   IOM: To Err Is Human: Building a Safer Health System, 1999 , page 37 Accessed 
                                                                                     10-31-11 at
                                                            http://www.nap.edu/catalog/9728.html
RECOMMENDATION 7.3 The Food and Drug Administration
(FDA) should increase attention to the safe use of drugs in both pre- and
post-marketing processes through the following actions:
     • develop and enforce standards for the design of drug packaging
     and labeling that will maximize safety in use;
     • require pharmaceutical companies to test (using FDA-approved
     methods) proposed drug names to identify and remedy potential
     sound-alike and look-alike confusion with existing drug names; and
     • work with physicians, pharmacists, consumers, and others to
     establish appropriate responses to problems identified through postmarketing 
     surveillance, especially for concerns that are perceived to require immediate 
     response to protect the safety of patients.



            IOM: To Err Is Human: Building a Safer Health System, 1999 , page 13 Accessed 
                                                                              10-31-11 at
                                                     http://www.nap.edu/catalog/9728.html


                                                                                                           19
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                                                                  Global Strategic Marketing & Market Access
 Chronology — FDA Name Review




• Search of Databases
• POCA
• Expert Panel
• Prescription Studies
      • Verbal Orders
      • Written In-Patient (Hospital) Order
      • Written Out-Patient (Retail) Prescriptions
• FMEA
      • Identical prefix
      • Identical infix
      • Identical suffix
      • Length of name
      • Overlapping product characteristics
• Consultation with FDA Stakeholders
• Final decision




                                                     Global Strategic Marketing & Market Access
                                                     Global Strategic Marketing & Market Access
Chronology — FDA & TM-related Medication Safety
                •FDA had no formalized process or organizational unit to perform TM review
Prior to 1990

                •FDA established the Labeling & Nomenclature Committee (LNC) to review
1990            TMs across all divisions. [LNC were FDA volunteers]


                • IOM published “To Err is Human: Building a Safer Health System”
                • FDA established Office of Post-marketing Drug Risk Assessment (OPDRA) to
                minimize LASAs. OPDRA full-time staff performed a multifactorial TM review
1999            but did not have approval authority/Panel for Rx Simulation FDA employees



                • FDA transitioned from OPDRA to Division of Medication Errors & Technical
                Support (DMETS) to perform TM reviews. DMETS did not have approval
2002            authority; only consultative to division directors who had that authority
(TM             • Two review procedures added: Phonetic and Orthographic Computer
Rejection       Analysis (POCA) & Failure Mode & Effect Analysis (FMEA)
Rate: 31%)


                •FDA, ISMP & PhRMA meeting in June on “state of the art” found no “gold
                standard” for TM review; in December, Drug Safety Risk Management
2003 (TM        Advisory Committee met and recommended stakeholders develop a fact-
Rejection       based process for TM safety review
Rate: 29%)


                •IOM published “Preventing Medication Errors”
2006



                                                           Global Strategic Marketing & Market Access
                                                           Global Strategic Marketing & Market Access
             FDA Amendments Act (FDAAA) President Bush reauthorized
             Prescription Drug User Fee Act (PDUFA IV) with funding for TM
2007         review which included the Pilot Program – Goals :(Review
             time/transparency of process/best methods), FTE’s


             •FDA transferred DMETS activities to a new unit: DMEPA (Division
2008 (TM     of Medication Error and Prevention Analysis)
Rejection    •DMEPA had full signatory authority approval authority
Rate: 36%)


             •Trademark review process under the Pilot Program started
2010 (TM     •Increased interaction on part of DMEPA with Industry relative to
Rejection    decisions and in responding to queries
Rate: 39%)


             • FDA announced it was not able to evaluate the Pilot Program due
             to the low level of participation by industry
             •PhRMA issued a response to Pres. Obama’s Executive Order
             13563 calling for repeal of the regulation that deals with FDA
             review of trademarks
             •ISMP responded to the PhRMA report by suggesting FDA, PhRMA
2011
             and other stakeholders should find a way to improve the current
             process because about 25% of medication errors are linked to
             TMs that have similarity to other TMs
             •After close of the public comment period, FDA intends to publish
             a draft guidance describing the best test methods for proprietary
             name evaluation (Comments due Nov.10, 2011 11:59 PM ET)

                                                  Global Strategic Marketing & Market Access
                                                  Global Strategic Marketing & Market Access
FDA PDUFA PILOT PROGRAM
Industry To Conduct Its Own Review of
Proposed TM

                                   Fed Reg 76(196) OCT 12,
 Fed Reg 74(189) OCT                        2011
       1, 2009

   •Two year voluntary         • Only 3 applications during 
   program                       the 2-year period
   •Goal is have 25 to 50      • Only 1 complete 
   submissions                   submission
   •IND, NDA, ANDA and BLA     • Insufficient participation to 
   qualify for participation     assess feasibility
   •Companies must register    • Therefore, the previously 
   for Pilot Program             anticipated public meeting 
   •Participation 120 days       was not held since “Agency 
   before planned submission     did not receive sufficient 
   •Submit data package          pilot submissions to form a 
   •Opportunity to discuss       basis for discussion.” 
   issues with DMEPA



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                                    Global Strategic Marketing & Market Access
FDA PDUFA PILOT PROGRAM
Industry To Conduct Its Own Review of
Proposed TM

                                    Fed Reg 76(196) OCT 12,
Fed Reg 74(189) OCT                          2011
      1, 2009

  •Two year voluntary         • Only 3 applications during 
  program                       the 2-year period
  •Goal is have 25 to 50      • Only 1 complete 
  submissions                   submission
  •IND, NDA, ANDA and BLA     • Insufficient participation to 
  qualify for participation     assess feasibility
  •Companies must register    • Therefore, the previously 
  for Pilot Program             anticipated public meeting 
  •Participation 120 days       was not held since “Agency 
  before planned submission     did not receive sufficient 
  •Submit data package          pilot submissions to form a 
  •Opportunity to discuss       basis for discussion.” 
  issues with DMEPA



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                                   Global Strategic Marketing & Market Access
Chronology — EMA Name Review
  Single Name requirement !




                                                                          2012 NRG 
                                                                          New 
                                                                          Guidance !




     Source: Zaide Frias, NRG Chair, Presentation at 2009 AESGP Members Meeting, Feb. 4, 2009,
                                                                                       Madrid

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     TM Review Chronology
                         FDA                                  YEAR                                         EMA
LNC (FDA volunteers) established                             1990

                                                                           1995   IN reviewed by CHMP at Plenary Session

                                                                           1998   First IN Guideline

IOM “To Err is Human;” OPDRA (full-time staff) established          1999          IN Guideline Rev. 01 & TRAHG Satellite Mtg.

                                                                           2000   IN Guideline Rev. 02 & Orphan Drug Regs.

OPDRA → DMETS (neither had approval authority)                      2002          IN Guideline Rev. 03

FDA, ISMP & PhRMA Mtg. (June); DSRMAC Mtg. (Dec)
                                                                    2003          Annex 1 (Dir. 2001/83/EC) (CTD)
recommends fact-based process for TM safety review

                                                                           2004   Title IV Reg. 726/04

                                                                           2005   IN Guideline Rev. 04 & Name change to NRG

                                                                                  Pediatric Legislation; Joint Mtg. (Sept. ) with EMA NRG and
IOM “Preventing Medication Errors”                                  2006
                                                                                  Interested Parties (AESGP, EFPIA, EGA) regarding IN Rev. 05
                                                                                  Advanced Therapy Legislation;  “Guideline on
FDAA A allocates $$$ for TM Review & TM Pilot Program                             the Acceptability of Names for Human
                                                                    2007
(TMPP)                                                                            Medicinal Products Processed Through the
                                                                                  Centralised Procedure “ (IN Rev. 05)
DMETS → DMEPA (DMEPA has approval authority)                 2008
TM Pilot Program (TMPP)Starts; Guidance for Industry:
“Contents of a Complete Submission for the Evaluation of     2010
Proprietary Names “
                                                                                  IN Guideline Revision 6 – NRG Workstream for
TMPP closed; PhRMA calls for repeal of TM Rev. Process       2011
                                                                                  2012 Global Strategic Marketing & Market Access
                                                                                         Global Strategic Marketing & Market Access
Regulatory Nomenclature Review

 • The following Health Agencies/countries have established a
   formal review of trademarks:
   – FDA/DMEPA- US
   – EMEA/NRG – EU – 27 Member States – Single TM Rule  
   Health Canada        MoH South Africa 
   ANVISA in Brazil     MoH Australia
   MoH Japan             MoH  Russia
   MoH Mexico
   – Varied methods/3 – letter rule
   – Proliferation of unused names on National authorizations
   – All share same common goal – error minimization



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Regulatory Considerations

    While  all  agencies  evaluate  nomenclature  with 
    the  same  objective (Patient Safety),  their 
    opinions  regarding  the acceptability  of proposed 
    names is not always consistent.  This is primarily 
    due  to  the  differentiating  pharmaceutical 
    nomenclature  landscape  and  prescribing 
    practices.


    Therefore, for example, approval with FDA
     does not constitute/guarantee approval
                    with EMEA.


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                                     Global Strategic Marketing & Market Access
FDA — EMA Comparison
Current Guidelines for Names

         FDA                                            EMA


                                       • Guideline on the Acceptability of 
• Guidance for Industry Contents of      Names for Human Medicinal 
  a Complete Submission for the          Products Processed Through the 
  Evaluation of Proprietary Names        Centralised Procedure  (12/2007) 
  (2/2010)                               REVISION 5/2010 Re-Use of
                                         Invented Names
• DMEPA (Division of Medication 
  Error Prevention and Analysis)       • NRG (Name Review Group)

• http://www.fda.gov/downloads/Dr      • http://www.emea.europa.eu/docs/
  ugs/GuidanceComplianceRegulator        en_GB/document_library/Regulato
  yInformation/Guidances/ucm0750         ry_and_procedural_guideline/2009
  68.pdf                                 /10/WC500004142.pdf


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                                                 Global Strategic Marketing & Market Access
Will I derail?




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                 Global Strategic Marketing & Market Access
   FDA
   Submission of Proposed Proprietary Names
IV. CONTENTS OF A COMPLETE SUBMISSION FOR EVALUATION OF PROPOSED
  PROPRIETARY NAMES
  A. General Information
  “REQUEST FOR PROPRIETARY NAME REVIEW” in bold, capital letters on the first 
    page of the 
  submission. 
       1.Proposed first choice proprietary name
       2.Application number (BLA/NDA/ANDA/IND)
       3.Applicant or sponsor contact information
       4.Identification of the submission as a Request for Proprietary Name Review
  B. Proposed Proprietary Name
       1.Primary and Alternate Proposed Proprietary Name
       2.Intended Pronunciation of the Proposed Proprietary Name’
       3.Derivation of Proprietary Name
       4.Intended Meaning of Proprietary Name Modifiers (e.g., prefix, suffix)
       5.Pharmacologic/Therapeutic Category        On FDA Form 1571, we recommend that you provide 
                                                       the proposed proprietary name under item 11 by 
                                                       checking “Other” and providing the proposed 
                                                       proprietary name in the accompanying box. On FDA 
                                                       Form 356h, we recommend you include the 
                                                       proposed proprietary name under the section 
                                                       “Application Description” by providing the proposed 
                                                       proprietary name in the box labeled “Reason for 
                                                       Submission.” 

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                                                                Global Strategic Marketing & Market Access
FDA
Submission of Proposed Proprietary Names

  C. Additional Information about the Product
        1.Submission for a Product That Has Proposed Labels and Labeling
              a.Proposed Labeling
              b.Proposed Container Labels and Labeling
        2.Submission for a Product Without Proposed Labeling
              a.Established Name
              b.Prescription Status
              c.Dosage Form(s)
              d.Product Strength(s)
              e.Proposed Indication(s) for Use
              f.Route(s) of Administration
              g.Usual Dosage, Frequency of Administration, Dosing Interval, Maximum Daily Dose
              h.Dosing in Specific Populations               FDA FORM 1571
              i. Instructions for Use                        http://www.fda.gov/downloads/AboutFDA/ReportsManua
                                                             lsForms/Forms/UCM083533.pdf
              j.Storage Requirement                          FDA FORM 356h
              k.How Supplied and Packaging Configuration     http://www.fda.gov/downloads/AboutFDA/ReportsManua
                                                                    lsForms/Forms/UCM082348.pdf
  D. Information About Product Dispensing and            Delivery
        1.Likely Care Environment(s) for Dispensing      and Use
        2.Delivery System                                http://www.fda.gov/downloads/Drugs/GuidanceComplia
        3.Measuring Device                               nceRegulatoryInformation/Guidances/ucm075068.pdf

  E. Applicant’s Assessments of Proprietary Name, Packaging, and/or Labeling



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                                                                      Global Strategic Marketing & Market Access
EMA
Request for Invented
Name


  www.ema.europa.eu/docs/en_GB/document_library/
  Template_or_form/2009/10/WC500004148.doc




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                      Staffing Comparison
  FDA/DMEPA                               EMA/NRG

DMEPA                               NRG
 Division Director:                  • Chair: Isabelle Moulon, MD
 Carol Holquist, RPh,                • EMA Secretary (1)
   • Director Regulatory (3)         • Pharmacist (1)
   • General Health Scientist (2)    • NRG Reviewers(Approx 16-
   • Health Programs                   17)
      Coordinator (1)
   • Lead Interdisciplinary          • Composed of representatives 
      Scientist (5)                    from EU member states and 
   • Lead Pharmacist (1)               European Commission. 
   • Medical Officer (1)             • Note: relevant experts, e.g.,  
   • Pharmacist/Reviewers(20)          WHO, consulted on a case-by
   • Senior Regulatory (2)             -case basis
 TOTAL STAFF: 36
                                          TOTAL STAFF: 19-20

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                                       NRG composition
                       Romance

                                                                                     Germanic

Slavic




                                                    



   Baltic


                                                                                       Uralic

                               Greek                             Semitic
                                                                                           36
     36
         Meeting participant                           Global Strategic Marketing & Market Access
                                                       Global Strategic Marketing & Market Access
     FDA Regulations  - Safety
• 21 CFR 201.10 (c.) “The labeling of a drug may be misleading by 
  reason (among other reasons) of:
  – (5) “Designation of a drug or ingredient by a proprietary name 
    that, because of similarity in spelling or pronunciation, may be 
    confused with the proprietary name or the established name of a 
    different drug or ingredient.”




                                          Global Strategic Marketing & Market Access
                                          Global Strategic Marketing & Market Access
  DMEPA Proprietary Name Review
• Name Review and Analysis Begins:
  – End of Phase II 
  – Submit 2 names
     • Primary (1st choice)
     • Secondary (2nd choice)

• Name Also Reviewed:
  – Filing of NDA/BLA/ANDA & 90 days prior to approval of NDA

• 180 day review clock for IND’s and 90 day review clock for 
  NDA’s/BLA’s/ANDA’s




                                           Global Strategic Marketing & Market Access
                                           Global Strategic Marketing & Market Access
FDA Preliminary Screening

ü Preliminary Screening of all Trademarks (prior to safety 
  research) for:
     – Dosing Interval
     – Dosage form/Route of Administration
     – Abbreviations
     – SA/LA drugs
     – Suggesting the composition one ingredient over others
ü USAN Stem Search (prior to research)
     – Identification of the stem
     – Location of the stem



39

                                        Global Strategic Marketing & Market Access
                                        Global Strategic Marketing & Market Access
  What Is DMEPA Looking For?
• Sound-alike/Look-alike:
  – To currently marketed drug names
  – To drug names pending approval
  – To other Medicinal Products
  – To commonly used medical abbreviations, medical 
    procedures, and/or lab tests
  – Focus of review - avoid medication errors
    Evaluate not only name but also error prone aspects of:
    Labels
    Labeling 
    Packaging
  – Handwriting samples analysis changing
  – “Word Shape”


                                        Global Strategic Marketing & Market Access
                                        Global Strategic Marketing & Market Access
     Regulations - Promotional

• 21 CFR 201.10(c) “The labeling of a drug may be misleading by reason 
  (among other reasons) of:
  – (3) “The employment of a fanciful proprietary name for a drug or 
    ingredient in such a manner as to imply that the drug or ingredient has 
    some unique effectiveness or composition when, in fact, the drug or 
    ingredient is a common substance , the limitations of which are readily 
    recognized when the drug or ingredient is listed by its established 
    name.”

     What Is DDMAC looking For?
  • Promotional/Misleading Claims
     – CureAll
     – Healmax




                                               Global Strategic Marketing & Market Access
                                               Global Strategic Marketing & Market Access
NOTE :Review conducted by DDMAC in EPD
 Opinion included in DMEPA review
 Focus of review - “fanciful” names, false 
 and/or misleading claims embedded in 
 name 
 Superiority claims
 Claims for different or expanded indications
 Claims for efficacy or safety not supported 
 by data
 DDMAC Objection
 Division Agrees – Safety review not 
 conducted

  Varies by TA



                             Global Strategic Marketing & Market Access
                             Global Strategic Marketing & Market Access   42
     Guidelines on Acceptable Names
     EMA Name Review Group (NRG)
     • Invented name cannot be similar to an existing INN 

     • Invented name cannot contain an existing INN stem

     •  The invented name should not convey any promotional message 
       with respect to therapeutic and/or pharmaceutical characteristics 
       and/or the composition of the medicinal product. 

     • The invented name should not appear offensive or have a “bad” 
       connotation in any of the official EU languages. 

     • The invented name of a fixed combination medicinal product should 
       be sufficiently different from those of the individual active 
       substances and/or those of other fixed combinations containing the 
       same active substance(s). 

     • For a medicinal product containing a prodrug, a different invented 
       name from the invented name of the medicinal product containing 
       the related active substance is required 
EMA CHMP : GUIDELINE ON THE ACCEPTABILITY OF NAMES FOR HUMAN MEDICINAL PRODUCTS PROCESSED THROUGH THE CENTRALISED PROCEDURE. 
London, 11 December 2007 CPMP/328/98, Revision 5 
http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004142.pdf


                                                                               Global Strategic Marketing & Market Access
                                                                               Global Strategic Marketing & Market Access
NRG Review
European Medicines Agency (EMA)
  Submit an invented name request - EMA 
  report as early as 18 months, but no 
  later than 4 months prior to the 
  submission of the Marketing 
  Authorization Application (MAA)
  Submit up to 4 name candidates
  Review time is 2-3 months

•Submission should be complete.
•Can amend packages to include additional 
information, or for rejustifications



                              Global Strategic Marketing & Market Access
                              Global Strategic Marketing & Market Access   44
        What’s the EMEA looking for?
     What Is NRG Looking For?


     üSound-alike and Look-alike to other EU names
     üPromotional or misleading concerns
     üLinguistic concerns with all languages in EU
     üINN Stems
     üModifiers
     üHandwritten Concerns



45

                                                Global Strategic Marketing & Market Access
                                                Global Strategic Marketing & Market Access
Considerations are Dependent 
on Type of Submission FDA and EMA
• New Molecular Entity

• Product Line Extension

• Different proprietary names for the same active ingredient
   – Potential for confusion, overdosing, concomitant administration, 
     allergies, hypersensitivity reactions
   – Generally discouraged

• Same proprietary name for different active ingredient
   – “Family” trade names for OTC products (e.g., Dulcolax, Robitussin, 
     Maalox, Zyrtec)
   – Foreign trade name (e.g., Dilacor – Diltiazem U.S. and Digoxin in 
     Serbia) US only

• Each type offers unique opportunities for error




                                                    Global Strategic Marketing & Market Access
                                                    Global Strategic Marketing & Market Access
 .
Request for Proprietary                 DDMAC EPD                         Expert
                                                                      Panel Discussion
    Name Consult                      Negative Decision
                                                                          (EPD)


 Requests
                           Consult        Project
 Name(s)
                                          Manager                          Rx Name
                                                                            Studies

Product     Reviewing                   DMEPA
Sponsor      Division                   Division                            POCA
                                                                           Computer
                                                                            Analysis
                        Decision by OSE/DMEPA


                                                                            Safety
                                     Supervisory Review                    Evaluator
                                         TL/Deputy                          FMEA


                                                 Global Strategic Marketing & Market Access
                                                 Global Strategic Marketing & Market Access   47
      Request for Invented
         Name Consult
                                      Sound-alike
                                                                        EMEA
     •.              NRG
     Requests               Consult    Member
      Names         Manager
                                        States     INN
                                                  Stems
                                       Look-alike
                                                                   NRG
     Product      EMEA                                          Discussion
     Sponsor

                CHMP Decision



                             NRG                  •Isabelle Moulon
                        Recommendation

48

                                             Global Strategic Marketing & Market Access
                                             Global Strategic Marketing & Market Access
 FDA — EMA
                                           FDA                                 EMA

Number of Names                                                            4**
                                           2*
Permitted to be Submitted                                         Approx 5 meeting s per
                                      Rolling Basis
for Consideration                                                          year
Earliest Name(s) May be         End of Phase 2 of the IND        18 months prior to MAA
Submitted                                process                      submission
                                NDA/BLA/Supp: 90 days
Trademark Review Clock              IND: 180 days                     Approx 2 months
                                     ANDA: N/A
                               Provisional Approval only            Up to 4 names
Reservation of TM?            until 90 days prior to PduFA       Some with “Provisional”
                                          date                          caveat
Number of Names
                                       134 (2010)                     648 (2011)
Reviewed
                                                               4.8x more names reviewed
Appeals /Rejustifications
                                           Yes                            Yes
permitted
       *Must indicate preferred primary name on submitted request for review
       **Must indicate acceptable invented name of choice 1 month before CHMP
       adoption


                                                         Global Strategic Marketing & Market Access
                                                         Global Strategic Marketing & Market Access
Methodology comparison
         Checks           FDA                  EMA
 Compendiums/             -----                  a
 Natl. Authorizations

 Expert Panel             a       a Varies by Member  State

 Data Base Searches/on    a                      a
 line references
 POCA                     a                      ----
 Medication Error Data*
                          a                      ----
 Name Simulation 
 Studies                  a                      ----

 Applicants Name                                 a
 Assessments              a

 FEMA                     a                      ----
 Harm Analysis
                          __                     a

                                  Global Strategic Marketing & Market Access
                                  Global Strategic Marketing & Market Access
Name Review Process
          Checks           FDA                     EMA
 Look Alike/ Sound Alike   a                          a
 Promotional               a                          a
 Linguistic                --                         a
 Safety Review             a                          --
 Spelling                  a                          a
 Pronunciation             a                          a
 Scripted                  a                          --
 Orthographic Appearance   a                          a
 Product Characteristics   a                          a
 Dosage Form               a                          a
 Route of Administration   a                          a
 USAN/INN Stem             a                          a

                                 Global Strategic Marketing & Market Access
                                 Global Strategic Marketing & Market Access
FDA — EMA
                                      FDA                               EMA
Agency’s Lead Review
                                    DMEPA                               NRG
Group
Authorized to
                                    DMEPA                          NRG/CHMP
Approve/Reject Name
Other Reviewers’ Input     OND and/or OGD, DDMAC, Member States, EC, WHO,
Sought                     other relevant CDER offices other relevant experts
Applicant’s Own Safety
Assessment of Name                    Yes                                Yes
Permitted
Multiple TM for Same INN       Varies; usually not       Not unless submitted via a
Permitted                          permitted                  separate MAA
Modifiers/Qualifiers
                                      Yes                                Yes
Permitted
Post-marketing
Requirement Regarding
                               Yes (occasionally)              Yes (occasionally)
Prescription/Medication
Errors Related to Name

                                                     Global Strategic Marketing & Market Access
                                                     Global Strategic Marketing & Market Access
FDA — EMA
                     FDA               EMA
Face-to-face
                     Yes                No
Meetings
                     Yes                Yes
Teleconference
Formal Review
                     Yes                No
Process Published
TM Rejection Rate
                     No                 Yes
Published
Direct Interaction
with                 No                 Yes
PHRMA/EFPIA
Public
Meeting/Interest
                     Yes                Yes
ed Parties
Meeting
NDA/MAA
Approval without     Yes                Yes
TM Approval

                           Global Strategic Marketing & Market Access
                           Global Strategic Marketing & Market Access
Regulatory Considerations:Summary
                  FDA/DMEPA                                  EMEA/NRG
 •   Approx 42% rejection rate -rolling basis      •Approx 48% rejection rate         - meet 5 x per
                                                   year
 •Evaluates only 1 name at a time (1 + can be
 submitted)- must prioritize                       •Under Centralised Review Process /Single
                                                   Trademark requirement - Harmonisation
 •Evaluates back-ups only after primary mark is
 rejected                                          • Evaluates up to 4 names simultaneously –
                                                   request prioritization
 •Will offer provisional feedback during IND
                                                   •Will offer feedback on name acceptability
 •Standard NDA/BLA TM Review - varies Fast         pre-MAA (every 2 months)- up to 18 months
 Track Status Considered                           prior to MAA

 •All provisional approvals are subject to final   •All approvals are subject to final review
 review during NDA process-90 Days prior to        during MAA process if exceeds set period
 PduFA or Final Action Date

                                                   •Analysis varies by Member State ( Expert
 •Performs multifactorial analysis inclusive of
 prescription simulation exercise & data           Panel, National compendiums, Marketing
 generation , expert panel discussion, and         Authorizations Listings)
 linguistic analysis
 Appeal Process Available - Rebuttal               Appeal Process Available -Rejustification
 •Will not continue to review additional names
 if a name has been approved                       Will review additional names even when a
                                                   name has been approved already

                                                             Global Strategic Marketing & Market Access
                                                             Global Strategic Marketing & Market Access
Latest Trends




           Global Strategic Marketing & Market Access
           Global Strategic Marketing & Market Access   55
New/Revised FDA and EMA Guidances
Planned 2012
                                                       EMA
                                                       Name Review Group
                                                       New Guidance/Revision
                                                       Workstream




  http://www.fda.gov/downloads/Drugs/GuidanceComplia
  nceRegulatoryInformation/Guidances/UCM079647.pdf




                                                        Global Strategic Marketing & Market Access
                                                        Global Strategic Marketing & Market Access
“First Out” Policy – MAH will use invented name 
provided they are granted with MA first
     Agenda Item                            XXX

     IN                                     XXX

     INNs/Stem                              XXX

     MAH                                    XXX

     Indication                             XXX
                                                   Provisional 
     Strength/PhForm                        XXX    Acceptance!
     RoA                                    XXX

     Legal Status                           XXX

     Orphan use                             XXX

     Appl Status                            XXX

     Conclusion                             The objections were endorsed as the risk
                                            of confusion in print and handwriting
                                            with the name of a pending submission 
                                            was deemed likely.

     However, having regard to the fact that the evaluation of the pending
     submission is still ongoing and the risk of confusion is not actual, it is
     considered that the MAH can use the invented name applied for
     (XXX) provided that they are granted with Marketing Authorisation
     first. Therefore, the proposed name is considered acceptable.

57
                                                        Global Strategic Marketing & Market Access
                                                        Global Strategic Marketing & Market Access
 “First Out” Policy – Provisional Acceptance
Question: Is it possible for a sponsor to follow-up
with NRG to determine the status of the pending
submission with similar invented
Name?
NRG Response:
-Advice would be that companies check the status of 
their accepted INs at the time of the pre-submission 
meeting, and then again when filing the submission of 
the actual dossier. In the context of a new MAA, we 
think those may be the most appropriate times to follow
-up the status of the IN, however should a company 
need to confirm the status of an IN that falls in the 
category you describe below, we will be happy to 
handle such a request at any other point in time.
 58
                                   Global Strategic Marketing & Market Access
                                   Global Strategic Marketing & Market Access
EMA Guidance Limiting 4 approved names
 “Following the acceptance of one additional invented 
 name for XXX at the November's NRG meeting, our 
 records indicate that the product has a total of 4 
 approved names. 
 Please note that according to the Guideline under 
 paragraph 4.2.1: "Up to four invented names per 
 marketing authorisation application can be proposed 
 for consideration". Furthermore there is no indication 
 for the use in multiple applications.”

 Please note the request for the review of additional 
 invented names for this product cannot be added to 
 the next agenda for January's meeting.



                                    Global Strategic Marketing & Market Access
                                    Global Strategic Marketing & Market Access
 EMA Guidance Limiting 4 approved names
Question 1: In instances where we have three
approved names but would like one more, why
can we not submit 4 names for review vs. 1 ?

NRG Response:
 With regard to your second question, this is something that will 
 certainly be tackled during the review of the NRG Guideline and we 
 will have the opportunity to exchange views on that, either during 
 the public consultation or in one of our joint meetings. For the time 
 being though, we will be handling the case you describe in the 
 following way: should you have already 3 approved INs for a 
 particular product, you can still submit 4 new proposed INs and the 
 NRG Group will review them all. If only one out of the 4 INs is 
 approved, there is no issue. If more than one IN is approved, you 
 will then be asked to confirm which is the name that you wish to 
 keep as your 4th approved IN and the rest will be deleted from the 
 NRG database.
  
 60
                                              Global Strategic Marketing & Market Access
                                              Global Strategic Marketing & Market Access
 EMA/NRG Guideline
Question 2: In instances where we have experienced FDA
rejection or another insurmountable obstacle to clearance
of a specific name, can we withdraw that name to allow
for another viable IN?

NRG Response:
   “We would like to note that currently the NRG guideline 
   does not provide for a withdrawal of an accepted invented 
   name. In view of the coming revision of the guideline, 
   where few points, including the withdrawal, will have to be 
   addressed, we have been quite flexible in the handling of 
   such requests. 
   On the other hand the sheer amount of names submitted 
   for review in each meeting together with cases of 
   withdrawal and subsequent submission of new names for 
   replacement made it even more complex and difficult to 
   handle.  

                                          Global Strategic Marketing & Market Access
                                          Global Strategic Marketing & Market Access
EMA/NRG Database Clearance

•All names accepted before 31 December, 2008, have been 
removed from the database, meaning the IN is no longer valid 
and these names will no longer be considered in the assessment 
of future names. 

•For all names approved after 1 January, 2009, the acceptance 
will be valid for 3 years, after which the names will be removed 
from the database.
Sponsors must request extensions to preserve those names 
database Deadline :December 2011




                                         Global Strategic Marketing & Market Access
                                         Global Strategic Marketing & Market Access   62
Strategies for Success
• Perform proper due diligence during Name Development

• Be Proactive – Conduct Name Safety and Market Research 
  Evaluations designed to identify safety concerns and linguistic 
  issues.

• Understand Global Nomenclature Review Processes (Distinctions/ 
  Overlaps and new procedures)

• Establish local network to assist with national product 
  nomenclature review and investigation (MA Listings, 
  Compendiums)

• Partner with and maintain open and transparent dialogue with 
  Health Authorities/be willing to conduct additional studies, provide 
  additional information, be innovative 

• Be responsive to inquiries, and provide proper data and analysis to 
  support appeals

• Abandon trademark candidates which present risk

                                              Global Strategic Marketing & Market Access
                                              Global Strategic Marketing & Market Access
Summary

• Patient safety continues to be a high priority for Industry,  FDA , 
  EMA , and among other key stakeholders

• There is considerable debate among FDA, industry and other 
  stakeholders on how best to improve patient safety, reduce 
  medication errors, and review proposed trademarks 

• The debate centers on nomenclature-related issues  and evaluation 
  methods with industry wanting to play a more active role in 
  providing input and contributing to  FDA’EMA processes and 
  guidances 

• Goal – Reduce Errors/Enhanced predictability 

• Open Dialogue 

• Partners in safety

                                                                                       64
                                              Global Strategic Marketing & Market Access
                                              Global Strategic Marketing & Market Access
The Crystal Ball




                   A Global Name?




65
                                    Global Strategic Marketing & Market Access
                                    Global Strategic Marketing & Market Access
Thank you!!




          Global Strategic Marketing & Market Access
          Global Strategic Marketing & Market Access   66
Medication Errors
• Any error occurring in the medication use process. Examples include 
  wrong dosage prescribed, wrong dosage administered for a prescribed 
  medication, or failure to give (by the provider) or take (by the patient) 
  a medication. (Bates et al., 1995) 
  http://www.ncbi.nlm.nih.gov/pubmed/7790981




• Any preventable event that may cause or lead to inappropriate 
  medication use or patient harm while the medication is in the control of 
  the health care professional, patient, or consumer. Such events may be 
  related to professional practice, health care products, procedures, and 
  systems, including prescribing; order communication; product labeling, 
  packaging, and nomenclature; compounding; dispensing; distribution; 
  administration; education; monitoring; and use. (National Coordinating 
  Council for Medication Reporting and Prevention [NCCMERP])
  http://www.nccmerp.org/aboutMedErrors.html



• NMRE’s – Name Related Medication Errors - A preventable event due to 
  confusion with a name


                                                                                         67
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                                                Global Strategic Marketing & Market Access
Useful Acronyms
               U.S.                                • ITU = Intent-to-Use Trademark Application 
• ANDA = Abbreviated New Drug Application
                                                   • MAPP = Manual of Policies & Procedures
• BLA =  Biologics 
                                                   • NDA = New Drug Application
• CDER = Center for Drug Evaluation &  
  Research                                         • OSE = Office of Surveillance & Epidemiology 

• DMEPA = Division of Medication Error             • PDUFA = Prescription Drug User Fee Act
  Prevention & Analysis 
                                                   • PhRMA = Pharmaceutical Research & 
• DTC = Direct-to-Consumer Advertising               Manufacturers of America

• FDA = U.S. Food & Drug Administration            • POCA = Phonetic Orthographic Computer 
                                                     Analysis 
• FDCA = Federal Food Drug & Cosmetic Act 
                                                   • USAN = U.S. Adopted Name 
• FMEA = Failure Mode & Effects Analysis
                                                   • USANC = U.S. Adopted Name Council
• AMA = American Medical Association
                                                   • USPTO = U.S. Patent & Trademark Office
• INDA = Investigational New Drug Application

• ISMP = Institute for Safe Medication Practices



                                                              Global Strategic Marketing & Market Access
                                                              Global Strategic Marketing & Market Access
Useful Acronyms
                 EU
                                                  • IN = Invented Name 
• AESGP = Association Européenne des 
  Spécialités Pharmaceutiques 
                                                  • INN = International Non-Proprietary Name
• CHMP = Committee for Medicinal Products for 
  Human Use                                       • MAA = Marketing Authorization Application 


• DCP = Decentralized Procedure                   • MAH = Marketing Authorization Holder


• EC = European Commission                        • MRA = Mutual Recognition Agreement


• EEC = European Economic Community               • MS = Member States


• EFPIA = European Federation of                  • NRG = Name Review Group 
  Pharmaceutical Industries & Associations
                                                  • PIN = Proposed Invented Name
• EGA = European Generic (Medicines) 
  Association                                     • WHO = World Health Organization

• EMA = European Medicines Agency

• EPAR = European Public Assessment Report

• ICH = International Conference for 
  Harmonisation of Technical Requirements for 
  Registration of Pharmaceuticals for Human Use


                                                             Global Strategic Marketing & Market Access
                                                             Global Strategic Marketing & Market Access

				
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posted:4/15/2014
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