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CDERs Advisors & Consultants Staff (ACS) Perspective on Preparing for Advisory Committee Meetings Igor Cerny, Pharm.D. Director, ACS CDER/FDA.

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Presentation on theme: "CDERs Advisors & Consultants Staff (ACS) Perspective on Preparing for Advisory Committee Meetings Igor Cerny, Pharm.D. Director, ACS CDER/FDA."— Presentation transcript:

1 CDERs Advisors & Consultants Staff (ACS) Perspective on Preparing for Advisory Committee Meetings Igor Cerny, Pharm.D. Director, ACS CDER/FDA

2 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium Key Points That Will Be Discussed Todays Perspective is CDERs Todays Perspective is CDERs Meeting Triggers Meeting Triggers Committee Basics Committee Basics Involvement / Roles of FDA Components in ACs Involvement / Roles of FDA Components in ACs Timelines Timelines Important Factoids Important Factoids Conflict of Interest Dilemma Conflict of Interest Dilemma Dos / Donts for Sponsor Dos / Donts for Sponsor Websites of Interest Websites of Interest

3 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium How Does FDA Determine the Need for the Meeting? No Set Criteria – Review Division Decides No Set Criteria – Review Division Decides Typical Triggers Include: Typical Triggers Include: Safety, Efficacy, Risk / Benefit Questions Safety, Efficacy, Risk / Benefit Questions Dosing Concerns Dosing Concerns Target Population or Labeling Issues Target Population or Labeling Issues New Molecular Entity / New Indication New Molecular Entity / New Indication Rx to OTC Switches Rx to OTC Switches Guidelines / Study / Protocol Designs Guidelines / Study / Protocol Designs Post-marketing Assessment Post-marketing Assessment Appeals of FDA Decisions Appeals of FDA Decisions

4 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium Composition of an Advisory Committee Members and Chair Appointed by Commissioner and Serve up to Four Years Members and Chair Appointed by Commissioner and Serve up to Four Years Members Include Consumer, Industry, and Sometimes Patient Representatives – All Represent Broader Interests Members Include Consumer, Industry, and Sometimes Patient Representatives – All Represent Broader Interests Consumer and Patient Representatives Appointed by FDA; However, Industry Reps Are Appointed by Industry Consumer and Patient Representatives Appointed by FDA; However, Industry Reps Are Appointed by Industry Committees Are Usually Supplemented With Additional Consultants Committees Are Usually Supplemented With Additional Consultants

5 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium Member Selection Referrals Come From: Referrals Come From: Former / Current Advisory Committee Members Former / Current Advisory Committee Members FDA Scientists FDA Scientists Professional Societies and Journals Professional Societies and Journals Academic Institutions Academic Institutions Consumer Groups Consumer Groups Self Nominations Self Nominations Congressional Staff Congressional Staff Industry Industry

6 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium Member Selection Continued Federal Register Notice for Nominations Federal Register Notice for Nominations Résumés Reviewed by Product Related Area Résumés Reviewed by Product Related Area Screened for Needed Expertise Screened for Needed Expertise Preliminary Screen for Conflicts of Interest Preliminary Screen for Conflicts of Interest Consideration is Made for Committee Balance: Race, Gender, Geography, Institution, e.g. Consideration is Made for Committee Balance: Race, Gender, Geography, Institution, e.g.

7 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium Whos Involved in AC Meetings on the CDER Side? The CDER Review Division The CDER Review Division Office of Drug Evaluation (ODE / CDER) Office of Drug Evaluation (ODE / CDER) Advisors & Consultants Staff (ACS / CDER) Advisors & Consultants Staff (ACS / CDER) Division of Information Disclosure Policy (DIDP) aka FOI (CDER) Division of Information Disclosure Policy (DIDP) aka FOI (CDER) Dockets (OC / FDA) Dockets (OC / FDA) FDA Ethics, ACOMS, Associate Commissioner for External Relations (OC), HHSs OGC (Conflict of Interest COI) FDA Ethics, ACOMS, Associate Commissioner for External Relations (OC), HHSs OGC (Conflict of Interest COI)

8 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium Depending on the Meeting, These Entities Can Also Be Involved Office of New Drugs (OND) Office of New Drugs (OND) Center Director Center Director Office of the Commissioner (OC) Office of the Commissioner (OC) Office of Surveillance & Epidemiology (OSE) Office of Surveillance & Epidemiology (OSE) One or More Review Divisions in CDER (Consult or Joint Meeting) One or More Review Divisions in CDER (Consult or Joint Meeting) Another Center (Biologics, Devices) Another Center (Biologics, Devices)

9 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium The FDA Review Division Reviews Product Application or Issue Reviews Product Application or Issue Determines the Need for the Meeting Determines the Need for the Meeting Develops Background Materials Develops Background Materials Develops and Rehearses Presentations Develops and Rehearses Presentations Develops Questions to the Committee Develops Questions to the Committee IDs Need for Additional Expertise (Other Committees, Consultants, Guest Speakers) IDs Need for Additional Expertise (Other Committees, Consultants, Guest Speakers) Limited Number Will Sit at the Table Limited Number Will Sit at the Table

10 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium CDER ACS ACS Makes Sure That the Meeting Process Satisfies FACA, FDAMA, CFRs, and FDA Policies / Memos ACS Makes Sure That the Meeting Process Satisfies FACA, FDAMA, CFRs, and FDA Policies / Memos Organizes and Coordinates Administrative Meeting Logistics: Backgrounder, Hotel, AV, Transcriber, Travel for Members / Consultants Organizes and Coordinates Administrative Meeting Logistics: Backgrounder, Hotel, AV, Transcriber, Travel for Members / Consultants The ACS Executive Secretary = Project Manager of the Meeting on the Admin End The ACS Executive Secretary = Project Manager of the Meeting on the Admin End Exec Sec is a Conduit for Information Between Review Division, Sponsor, AC Members, Public Exec Sec is a Conduit for Information Between Review Division, Sponsor, AC Members, Public

11 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium AC Meeting Deadlines (Business Days) Day 76+: Review Division Day 76+: Review Division Notifies Sponsor / ACS of Need for AC Meeting Notifies Sponsor / ACS of Need for AC Meeting Begins to ID & Notify Current / Prospective Additional SGE Consultants Begins to ID & Notify Current / Prospective Additional SGE Consultants IDs Topic, Starts Competing Product List IDs Topic, Starts Competing Product List Day 71: Review Division Submits to ACS Day 71: Review Division Submits to ACS Individuals Who Need to be Appointed as SGEs Individuals Who Need to be Appointed as SGEs Proposed FR Including Indication / Topics Proposed FR Including Indication / Topics Draft Competing / Affected Products List Draft Competing / Affected Products List Meeting Topics / Issues for Discussion Meeting Topics / Issues for Discussion

12 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium AC Meeting Deadlines (Business Days) Continued Day 61: ACS Day 61: ACS Receives Complete SGE Appointment Paperwork From Prospective SGE Receives Complete SGE Appointment Paperwork From Prospective SGE If Paperwork Not Received in ACS by This Date, Prospective SGE Will Not be Able to Attend Meeting If Paperwork Not Received in ACS by This Date, Prospective SGE Will Not be Able to Attend Meeting Day 55: Review Division / ACS Meet / Discuss Day 55: Review Division / ACS Meet / Discuss ACS's Changes (If Any) in the Division's Draft Competing / Affected Products List ACS's Changes (If Any) in the Division's Draft Competing / Affected Products List Draft Agenda / Questions Draft Agenda / Questions Need to Open a Docket? Need to Open a Docket?

13 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium AC Meeting Deadlines (Business Days) Continued Day 50: Review Division / ACS Day 50: Review Division / ACS Finalize / Sign-off on the FR Notice Finalize / Sign-off on the FR Notice Finalize Competing / Affected Products Finalize Competing / Affected Products Finalize Attendee List Finalize Attendee List Review Division Submits Final Current SGEs / Guest Speakers Review Division Submits Final Current SGEs / Guest Speakers Day 36: ACS Day 36: ACS Receives SGEs Complete Answers to COI Questions Receives SGEs Complete Answers to COI Questions Day 26: ACS Day 26: ACS Waivers Sent to Ethics / OC / Dockets / FOI Waivers Sent to Ethics / OC / Dockets / FOI Miss This Date = No Waivers = No SGE Miss This Date = No Waivers = No SGE

14 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium AC Meeting Deadlines (Business Days) Continued Day 22: Sponsor Day 22: Sponsor Submits Backgrounder to ACS Submits Backgrounder to ACS Day 19: Review Division Day 19: Review Division Submits Its Backgrounder to ACS Submits Its Backgrounder to ACS Day 18: ACS Day 18: ACS Sends Both Backgrounders to FOI for Redaction Review, Overnights Unredacted Backgrounder to the Committee Sends Both Backgrounders to FOI for Redaction Review, Overnights Unredacted Backgrounder to the Committee

15 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium AC Meeting Deadlines (Business Days) Continued Day 11 (15 calendar): Dockets Day 11 (15 calendar): Dockets Posts Waivers Onto the Web Posts Waivers Onto the Web Day 14: ACS Day 14: ACS ACS Overnights Redacted Version of CDER Backgrounder to Sponsor – Your First Look! ACS Overnights Redacted Version of CDER Backgrounder to Sponsor – Your First Look! 1 Business Day Prior to the Advisory Committee Meeting (24 Hours Prior to Meeting), FDA Posts on Its Website the Sponsor Package and CDER's Redacted Package 1 Business Day Prior to the Advisory Committee Meeting (24 Hours Prior to Meeting), FDA Posts on Its Website the Sponsor Package and CDER's Redacted Package

16 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium When Will You Get to See the Questions? If No Questions Are in Backgrounder, Hopefully Contact Between Sponsor & CDER Has Been Frequent & Meaningful so That Surprises Are Minimal (?) If No Questions Are in Backgrounder, Hopefully Contact Between Sponsor & CDER Has Been Frequent & Meaningful so That Surprises Are Minimal (?) ACS Has Been Encouraging Divisions to Include Either Points to Consider and / or a Cover Memo for the Backgrounder ACS Has Been Encouraging Divisions to Include Either Points to Consider and / or a Cover Memo for the Backgrounder ACS Has Also Encouraged Divisions to Avoid Regulatory Conclusions ACS Has Also Encouraged Divisions to Avoid Regulatory Conclusions

17 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium Important Factoids If Your Backgrounder Is Going to Be Late: Work With the Exec Sec (Consider DIDP & Dockets) If Your Backgrounder Is Going to Be Late: Work With the Exec Sec (Consider DIDP & Dockets) Errata Sheets Allowed for Sponsor & CDER Errata Sheets Allowed for Sponsor & CDER Actual Data Amendments Are Discouraged Actual Data Amendments Are Discouraged CDER Applies the Disclosability Guidance to Non-NDA Meetings for Consistency CDER Applies the Disclosability Guidance to Non-NDA Meetings for Consistency CDER Doesnt Release SGE Names, Specialties Only CDER Doesnt Release SGE Names, Specialties Only MAPP 6001.1: SGEs Appearing Before FDA MAPP 6001.1: SGEs Appearing Before FDA Other Feds Cant Represent You Before FDA Other Feds Cant Represent You Before FDA

18 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium FY 06 Appropriations Bill FY 06 Appropriations Bill none of the funds made available in this Act may be used to…grant a waiver of a financial conflict of interest…none of the funds made available in this Act may be used to…grant a waiver of a financial conflict of interest… [this] shall not apply to a waiver…if – (1) not later than 15 days prior to a meeting of an advisory committee, the Secretary of HHS discloses on the Internet website of the FDA…the nature and basis of such waiver…. [this] shall not apply to a waiver…if – (1) not later than 15 days prior to a meeting of an advisory committee, the Secretary of HHS discloses on the Internet website of the FDA…the nature and basis of such waiver…. Any SGE Who Needs a Waiver MUST Have This Waiver Posted on the Web 15 Calendar Days Before the Meeting – Your First Chance to See Some of the Added Consultants Who Will Be There! Any SGE Who Needs a Waiver MUST Have This Waiver Posted on the Web 15 Calendar Days Before the Meeting – Your First Chance to See Some of the Added Consultants Who Will Be There!

19 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium Criminal Conflict of Interest Statute Title 18 U.S.C. 208 Prior to Every Meeting Each SGE is Evaluated for Conflict of Interest Relative to the Meeting Topic Prior to Every Meeting Each SGE is Evaluated for Conflict of Interest Relative to the Meeting Topic SGE May Not Participate If the Individual Has a Financial Conflict of Interest. SGE May Not Participate If the Individual Has a Financial Conflict of Interest. Interests Are Also Imputed to the Spouse, Minor Child, and Employer. Interests Are Also Imputed to the Spouse, Minor Child, and Employer. If Disclosed in Advance – There are Provisions for Exceptions – WAIVERS If Disclosed in Advance – There are Provisions for Exceptions – WAIVERS

20 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium What Are the Types of Interests That Are Screened? Stocks and Investments Stocks and Investments Primary Employment Primary Employment Consultant Work Consultant Work Contracts / Grants / CRADAS Contracts / Grants / CRADAS Patent / Royalties / Trademarks Patent / Royalties / Trademarks Expert Witness Activities Expert Witness Activities Teaching / Speaking / Writing Teaching / Speaking / Writing Department Heads / Administrative Duties Department Heads / Administrative Duties Exceptions for Institutional Directors Exceptions for Institutional Directors

21 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium Conflict of Interest Continued FDA May NOT Grant a Waiver for an Advisory Committee Member to Review Their Own Work FDA May NOT Grant a Waiver for an Advisory Committee Member to Review Their Own Work COI Criteria Are VERY Complex – Mostly Shades of Gray COI Criteria Are VERY Complex – Mostly Shades of Gray Current FDA Criteria Used for COI Screening Are Found on the Web Current FDA Criteria Used for COI Screening Are Found on the Web

22 COI Clearance Workflow CDER ACS (Working w/ Review Division) Assesses of Matter at Issue, IDs All Entities With Financial Interest Reviews SGEs Reported Interests Against Waiver Criteria Document Prepares Waivers for Ethics & Integrity Staff Review Forwards Waivers to FOI for Redaction FDAs Ethics & Integrity Staff Reviews Waiver, Recommends to ACOMS ACOMS Reviews Waiver in Consult w/EIS Makes Recommendation to the Associate Commissioner Associate Commissioner Approves or Denies Waiver ACOMS Notifies Center of Reason for Waiver Denial Division of Documents Management Posts Approved Waivers & Consent For Disclosure for Advisory Meetings on FDAs Internet CDER ACS Forwards Approved Redacted Waivers and Consent for Disclosure Documents to Dockets Notifies Review Div. of Denied Waiver

23 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium Conflict of Interest Dilemma Congress, Consumer Watchdog Groups, the Public Want AC Members With Minimal Conflicts – Who Doesnt? Is That Possible? Congress, Consumer Watchdog Groups, the Public Want AC Members With Minimal Conflicts – Who Doesnt? Is That Possible? Ideal AC Member Has Practitioner + Clinical Trials Experience Ideal AC Member Has Practitioner + Clinical Trials Experience Where Does One Get Clinical Trials Experience? Where Does One Get Clinical Trials Experience?

24 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium Conflict of Interest Dilemma Continued Since Drug Development Is Primarily Funded by Private Sector, Most Clinical Trial Experience Is Gained by Working With Industry-Sponsored Trials Since Drug Development Is Primarily Funded by Private Sector, Most Clinical Trial Experience Is Gained by Working With Industry-Sponsored Trials We Dont Want AC Members Who Lack Clinical Trial Experience – Cant Properly Advise FDA, Can Potentially Hurt the Company, Hurt the Public (95% of Time, FDA Agrees With AC) We Dont Want AC Members Who Lack Clinical Trial Experience – Cant Properly Advise FDA, Can Potentially Hurt the Company, Hurt the Public (95% of Time, FDA Agrees With AC) FDA will continue to refine how it discloses the Balance Between Experience and Conflict FDA will continue to refine how it discloses the Balance Between Experience and Conflict

25 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium DOs for the Sponsor Keep Up the GREAT Work Regarding Rehearsals – Presentations are Excellent Keep Up the GREAT Work Regarding Rehearsals – Presentations are Excellent Keep Up the GREAT Work Regarding Back-up Slides – Some Are Amazing Keep Up the GREAT Work Regarding Back-up Slides – Some Are Amazing Keep Up the GREAT Work in Knowing the Committee Keep Up the GREAT Work in Knowing the Committee Encourage Review Divisions to Put Questions in Their Backgrounder; in Place of That, Ask for Either a Points to Consider Document and / or a Backgrounder Summary Memo Encourage Review Divisions to Put Questions in Their Backgrounder; in Place of That, Ask for Either a Points to Consider Document and / or a Backgrounder Summary Memo

26 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium DONTs for the Sponsor Dont Forget: CDER Doesnt Release SGE Names – Other Centers Do – We Release Specialties (SGE Clearance Hard to Predict) Dont Forget: CDER Doesnt Release SGE Names – Other Centers Do – We Release Specialties (SGE Clearance Hard to Predict) Dont Forget About MAPP 6001.1: SGEs Representing You in Front of FDA Dont Forget About MAPP 6001.1: SGEs Representing You in Front of FDA Ex-FDAers Have a Lifetime If Worked on That Issue; 1-Year Cooling-off Otherwise Ex-FDAers Have a Lifetime If Worked on That Issue; 1-Year Cooling-off Otherwise Other Feds Cant Represent You Before FDA Other Feds Cant Represent You Before FDA Dont Forget: Sponsor Package Goes to FOI Dont Forget: Sponsor Package Goes to FOI Dont Spring New Data or B.S. Committee Dont Spring New Data or B.S. Committee Dont Lose Your Cool! Dont Lose Your Cool!

27 August 22, 2006Pre-Conference Workshop I: The Second Annual FDA Regulatory & Compliance Symposium Websites of Interest 1 (One) Business Day Prior to the Meeting – CDER Posts Both Backgrounders Onto the Web at: http://www.fda.gov/ohrms/dockets/ac/acmenu.htm 1 (One) Business Day Prior to the Meeting – CDER Posts Both Backgrounders Onto the Web at: http://www.fda.gov/ohrms/dockets/ac/acmenu.htm Disclosability Guidance at: http://www.fda.gov/cder/guidance/3479dft.htm Disclosability Guidance at: http://www.fda.gov/cder/guidance/3479dft.htm Conflict of Interest Criteria at: http://www.fda.gov/oc/advisory/conflictofinterest/intro.html Conflict of Interest Criteria at: http://www.fda.gov/oc/advisory/conflictofinterest/intro.html MAPP 6001.1 at: http://www.fda.gov/cder/mapp/6001-1.pdf MAPP 6001.1 at: http://www.fda.gov/cder/mapp/6001-1.pdf


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