1. THE LAW OFFICES OF MICHAEL A. SWIT
SUCCESSFUL FDA MEETINGS DIA West Coast Drug Development Conference San Francisco, CA October 25, 2004
Michael A. Swit, Esq.
FDACounsel.com
THE LAW OFFICES OF MICHAEL A. SWIT
539 Samuel Ct., Suite 229
Encinitas, CA 92024
♦ fax:

2. Overview of Tutorial Part 1 -- The “Law” of Meetings
Part 2 – FDA’s Guidances, etc., on FDA Meetings
Part 3 – Details on the Different Types of Meetings
Part 4 – Tips and Traps
Part 5 – Q & A

3. What We’re Not Covering
Advisory Committee Meetings
Medical Device Meetings
“Exit Interviews” – meetings following FDA inspections
Public meetings, other than Advisory Committee meetings (e.g., Sept meeting on “follow-on” generics)
Hearings (e.g., Clinical Investigator Disqualification)
Meetings attended by FDA officials outside the agency (e.g., conferences, ICH meetings)
Formal dispute resolution processes

4. Part 1
The “Law” of Meetings

5. Where to Go for Perspective – or What is the Law Governing FDA Meetings?
Law School in 60 seconds
What is “law”?
U.S. Constitution
Statutes – Federal Food, Drug, and Cosmetic Act (“the Act”)
Regulations – force and effect of law – 21 CFR Part 54

6. Where to Go for Perspective – or What is the Law Governing FDA Meetings?
FDA advisory opinions – formal position of FDA; binding until refuted; FDA can’t take regulatory action vs. someone who relies on an FDA advisory opinion – 21 CFR 10.85(e)
Preambles to proposed or final rules = an advisory opinion – 21 CFR 10.85(d)(1)
“Common” law = case law

7. Where to Go for Perspective – or What is the Law Governing FDA Meetings?
What’s not “law”?
Anything else FDA writes – guidances, speeches, warning letters, complaints in Federal court –
“Guidance” –
“…describes the agency’s interpretation of or policy on a regulatory issue” – 21 CFR (b)(1)
“…do not legally bind the public or FDA…” – 21 CFR (d)(1)
But … by statute …

8. FDA Duty On Complying with Guidance Documents
Section 701(h)(l)(B) of FFDCA –
“Although guidance documents shall not be binding on the Secretary, the Secretary shall ensure that employees of the Food and Drug Administration do not deviate from such guidances without appropriate justification and supervisory concurrence.”

9. Where to Go for Perspective – or What is the Law Governing FDA Meetings?
So, where do we find the law of Meetings?
NOT:
in Constitution or the Common Law (for the most part)
YES:
Statutes – but only rarely
Regulation – but only in fairly general terms – 21 CFR 10.65

10. The rest is commentary …
Where to Go for Perspective – or What is the Law Governing FDA Meetings?
The rest is commentary …
Various guidance documents to be discussed in detail in Part 2 of this tutorial
FDA presentations at DIA, RAPS, etc.
Caution – the “commentary” requires careful attention
Ever notice that's Groundhog Day?
Rabbi Akiva -- while standing on one foot

11. Federal Food, Drug, and Cosmetic Act (FFDCA) Provisions Governing FDA Meetings
Section 505(b)(4) – added by Section 119 of The Food & Drug Modernization Act of 1997 (“FDAMA”) – or
The “FDA can’t change its mind unless there’s new safety/effective data” clauses.

12. Section 505(b)(4)(B)
The Secretary shall meet with a sponsor of an investigation or an applicant for approval for a drug under this subsection or section 351 of the Public Health Service Act if the sponsor or applicant makes a reasonable written request for a meeting …
for the purpose of reaching agreement on the design and size of clinical trials intended to form the primary basis of an effectiveness claim....
The sponsor or applicant shall provide information necessary for discussion and agreement on the design and size of the clinical trials....
Minutes of any such meeting shall be prepared by the Secretary and made available to the sponsor or applicant upon request.

13. Section 505(b)(4)(C)
Any agreement regarding the parameters of the design and size of clinical trials of a new drug under this paragraph that is…
reached between the Secretary and a sponsor or applicant …
shall be reduced to writing and made part of the administrative record by the Secretary….
Such agreement shall not be changed after the testing begins, except--

14. Section 505(b)(4)(C) …
with the written agreement of the sponsor or applicant; or
pursuant to a decision, made in accordance with subparagraph (D) by the director of the reviewing division, that a substantial scientific issue essential to determining the safety or effectiveness of the drug has been identified after the testing has begun.

15. Section 505(b)(4)(D)
A decision under subparagraph (C)(ii) by the director shall be in writing …
and the Secretary shall provide to the sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant will be present and …
at which the director will document the scientific issue involved.

16. FDA Regulations on Meetings
21 CFR 10.3:
“Meeting means any oral discussion, whether by telephone or in person.”
21 CFR 10.65:
(a) In addition to public hearings and proceedings established under this part and other sections of this chapter, meetings may be held and correspondence may be exchanged between representatives of FDA and an interested person outside FDA on a matter within the jurisdiction of the laws administered by the Commissioner….
Action on meetings and correspondence does not constitute final administrative action subject to judicial review under §

17. FDA Regulations on Meetings …
21 CFR 10.65(c) …
(c) Every person outside the Federal Government may request a private meeting with a representative of FDA in agency offices to discuss a matter. FDA will make reasonable efforts to accommodate such requests.
(1) The person requesting a meeting may be accompanied by a reasonable number of employees, consultants, or other persons with whom there is a commercial arrangement within the meaning of § 20.81(a) of this chapter....

18. FDA Regulations on Meetings …
21 CFR 10.65(c) …
(2) FDA will determine which representatives of the agency will attend the meeting….
The person requesting the meeting may request, but not require or preclude, the attendance of a specific FDA employee.

19. FDA Regulations on Meetings …
21 CFR 10.65(d):
FDA employees have a responsibility to meet with all segments of the public to promote the objectives of the laws administered by the agency.
[Note: rest of this subsection (d) deals with meetings outside of FDA]

20. FDA Regulations on Meetings …
21 CFR …
(e) An official transcript, recording, or memorandum summarizing the substance of any meeting described in this section will be prepared by a representative of FDA when the agency determines that such documentation will be useful.
(f) FDA promptly will file in the appropriate administrative file memoranda of meetings prepared by FDA representatives
and
all correspondence, including any written summary of a meeting from a participant, that relate to a matter pending before the agency.
(g) Representatives of FDA may initiate a meeting or correspondence on any matter concerning the laws administered by the Commissioner. Unless otherwise required by law, meetings may be public or private at FDA`s discretion.

21. FDA Regulations on Meetings …
21 CFR – the Administrative Record
(b) FDA employees responsible for handling a matter are responsible for insuring the completeness of the administrative file relating to it.
The file must contain:
(1) Appropriate documentation of the basis for the decision, including relevant evaluations, reviews, memoranda, letters, opinions of consultants, minutes of meetings, and other pertinent written documents …
(d) Memoranda or other documents that are prepared by agency employees and are not in the administrative file have no status or effect.

22. FDA Regulations on Meetings …
IND Regulations – 21 CFR Part 312
Meetings (a) General. Meetings between a sponsor and the agency are frequently useful…during the course of a clinical investigation.
Early consultation For products intended to treat life-threatening or severely debilitating illnesses, sponsors may request to meet with FDA-reviewing officials early in the drug development process…

23. FDA’s Guidances, etc., and The Handling of FDA Meetings
Part 2
FDA’s Guidances, etc., and The Handling of FDA Meetings

24. What Are the Guidances – on Meetings
“Formal Meetings with Sponsors and Applicants for PDUFA Products.” CBER/CDER, February
“Good Review Management Principles for PDUFA Products.” CDER/CBER. July
Manual of Policy and Procedure (MaPP) : “Formal Meetings Between CDER and CDER’s External Constituents.” CDER, March

25. What Are the Guidances – on Dispute Resolution
“Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP.” CDER/CBER/ORA/CVM, August
“Formal Dispute Resolution: Appeals Above the Division Level.” CDER/CBER, February 2000.
Manual of Policy and Procedure (MaPP) – “Resolution of Disputes: Role of Reviewers, Supervisors, and Management Documenting Views and Findings and Resolving Differences. CDER, August

26. What Are the Guidances – on Dispute Resolution …
Manual of Policy and Procedure (MaPP) – “Role and Procedures for the CDER Ombudsman.” CDER, October
Also see:
Guidance for Review Staff and Industry (Draft): “Good Review Management Principles for PDUFA Products.” CDER/CBER, July
Guidance for Industry: “Special Protocol Assessment.” CDER/CBER, May

27. “Formal Meeting” Guidance
Relates to PDUFA products – see § 735(1) of FFDCA for list of products
“The guidance document describes procedures for requesting, scheduling, conducting, and documenting such formal meetings….common to all CDER & CBER review divisions.”

28. “Formal Meeting” Guidance
Designed to:
Cover all formal meetings – i.e., “any formal, planned interaction between FDA and an external constituent that occurs face-to-face, via teleconference or via video conference”
Also implements § 119(a) of FDAMA
note that § 119(b) of FDAMA covers similar “binding agreement” language relative to ANDAs and was to be covered by a separate meetings guidance (not issued yet)
§ 119(a) meetings are those that relate to “special protocol assessments”
Incorporates procedures covered by CDER MaPP and CBER SoPP
Not applicable to informal meetings – which are not intended to be replaced by the formal meetings

29. “Formal Meeting” Guidance – Types of Meetings – “A,B,C”
Type A Meeting
“… one that is immediately necessary for an otherwise stalled drug development program to proceed (i.e., a critical path meeting)”
Generally reserved for:
Dispute resolution meetings
Clinical hold discussions
Special protocol assessment meetings requested by sponsors after FDA’s evaluation of protocols submitted via assessment letters

30. “Formal Meeting” Guidance – Types of Meetings – “A” …
Scheduling of Type A meeting:
Within 30 days of FDA’s receipt of a written request or
If sponsor requests a later date, within 14 days of the requested date

31. “Formal Meeting” Guidance – Types of Meetings – “B”
Covers:
Pre-IND meetings (21 CFR )
Certain end-of-Phase 1 meetings (21 CFR )
End of Phase 2/pre-Phase 3 meetings (21 CFR )
Pre-NDA/BLA meetings (21 CFR )

32. “Formal Meeting” Guidance – Types of Meetings – “B” …
Scheduling of Type B meeting:
Within 60 days of FDA’s receipt of a written request or
If sponsor requests a later date, within 14 days of the requested date

33. “Formal Meeting” Guidance – Types of Meetings – “B” …
Caveats
“generally” only one of each kind of Type B meeting for each potential application or combination of closely related products (e.g., same active ingredients, different dosage forms)
But, simultaneous development of a drug for unrelated claims may allow more than one of each kind of Type B meeting

34. “Formal Meeting” Guidance – Types of Meetings – “C’
Covers:
any meeting other than a Type A or B
Must still relate to the NDA/BLA for the PDUFA product. Thus, not applicable to:
Advertising, except pre-launch activities
Post marketing safety evaluation meetings

35. “Formal Meeting” Guidance – Types of Meetings – “C’ …
Scheduling of Type C meeting:
Within 75 days of FDA’s receipt of a written request or
If sponsor requests a later date, within 14 days of the requested date

36. “Formal Meeting” Guidance – Requesting Procedures
Written request (fax or letter) to:
CDER
Appropriate division director within:
Office of Review Management (ORM)
Office of Pharmaceutical Sciences (OPS)
Office of Medical Policy (e.g. for DDMAC)
If Type A, copy office director in ORM or OPS, when appropriate
CBER – appropriate division director with review responsibility or Advertising and Promotional Labeling Staff (APLS)

37. “Formal Meeting” Guidance – Requesting Procedures …
If pre-IND, request goes to the appropriate division director
Technical form of request – an amendment
IND stage – via 1571
NDA/BLA – via 356h (in triplicate)
If faxing
contact division ahead of time to confirm who should get request
Follow with “hard copy” submission
Note: if sent after hours (confirm ahead of time), will be deemed received next business day

38. “Formal Meeting” Guidance – Requesting Procedures …
Contents of Meeting Request – “adequate information” for FDA to decide “utility of meeting and to identify the Agency staff necessary to discuss proposed agenda …”
Specifically:
Product name and application # (if any)
Chemical name and structure
Proposed indications
Type of meeting sought (continued)

39. “Formal Meeting” Guidance – Requesting Procedures … Contents of Request Letter …
Specifically …
Brief statement of meeting purpose
Types of completed or planned studies or data to be discussed
General nature of critical questions to be asked
How meeting fits in overall development plans
List of specific objectives/outcomes sought
Preliminary proposed agenda
time needed per item
Designated speaker (continued)

40. “Formal Meeting” Guidance – Requesting Procedures … Contents of Request Letter …
Specifically …
Draft list of questions, by discipline
Chemistry
CMC & Microbiology (if applicable)
Pharm/Tox
Clinical Pharmacology & Biopharmaceutics
Clinical Microbiology
Clinical
Biostatistics
Administrative & Regulatory

41. “Formal Meeting” Guidance – Requesting Procedures … Contents of Request Letter …
Specifically …
List, w/titles, of all to attend for sponsor
Agency staff requested to attend– or disciplines of identity not certain –
Approximate date supporting documen-tation will arrive – “Information Package”
Suggested dates and times
 – some divisions will tell you the date/time prior to submitting request – call ahead to check on this

42. “Formal Meeting” Guidance – Requesting Procedures – FDA Handling
Division director – to promptly decide whether to hold meeting
Review division to respond within 14 days of receipt.
Response will include:
Date, time, place and length of meeting
Expected FDA participants

43. “Formal Meeting” Guidance – Requesting Procedures – FDA Handling …
If denied, FDA reply “should include” a clear explanation of the reason(s) for denial
Subsequent requests = new requests (clock starts over)
Cancellation or postponements
By applicant/sponsor – starts new cycle
By FDA – to be rescheduled within 30 days

44. “Formal Meeting” Guidance – Requesting Procedures – The “Information Package”
“FDA’s receipt of a full information package, including clear, thoughtful questions, in advance of a formal meeting with sufficient lead time to enable Agency staff to review the data adequately is critical to achieving a productive meeting.” Guidance, at page 6 (italics in original)

45. Failure to timely submit – FDA may postpone or cancel
“Formal Meeting” Guidance – Requesting Procedures – The “Information Package” …
Timing – when to submit
Type A – at least 2 weeks before
Type B – at least 4 weeks before
Type C – at least 2 weeks (but 4 is recommended) before
Failure to timely submit – FDA may postpone or cancel

46. “Formal Meeting” Guidance – Requesting Procedures – The “Information Package” – Contents
Product name and application # (if any)
Chemical name and structure
Proposed indications
Dosage form, route of administration, and dosing regimen (frequency & duration) (continued)

47. “Formal Meeting” Guidance – Requesting Procedures – The “Information Package” – Contents …
Brief statement of purpose of meeting
Types of completed or planned studies or data to be discussed
General nature of critical questions
Where meeting fits in overall development
List of specific objectives/outcomes expected
Proposed agenda
Time for each item
Designated speakers (continued)

48. List of specific questions by discipline
“Formal Meeting” Guidance – Requesting Procedures – The “Information Package” – Contents …
List of specific questions by discipline
Clinical data summary (as appropriate)
Preclinical data summary (as appropriate)
Chemistry, manufacturing and controls information (as appropriate)
 -- update any changed info from meeting request

49. “Formal Meeting” Guidance – Requesting Procedures – The “Information Package” …
Cover letter – identify date, time and subject of meeting
Organize contents according to the proposed agenda
Fully paginated
Table of contents
Indices
Cross references
Tabs for differentiating sections
Copies – # of FDA participants + 5

50. “Formal Meeting” Guidance – Conduct of the Meeting
FDA Chair
Introductions (sign-in sheet)
Identify who will record minutes and keep time
At end, should summarize:
All important discussion points
Decisions
Recommendations
Agreements
Disagreements
Issues for further discussion (note: not in guidance here, but is to be included in minutes)
Action items

51. “Formal Meeting” Guidance – Conduct of the Meeting …
Attendees – “should be given” an opportunity to comment, including critical items believe should be in minutes
Chair – attempts to resolve any differences
FDA recorder – “… should document the summary as the official minutes.”

52. “Formal Meeting” Guidance – Documentation of Meeting
Minutes – summarize, in bulleted form:
Important discussion points
Decisions
Recommendations
Agreements
Disagreements
Issues for further discussion
Action items

53. “Formal Meeting” Guidance – Documentation of Meeting …
Sponsors/applicants’ role vis-à-vis minutes:
May provide a draft
If do so, DO PROMPTLY
If done, “will be considered” in preparing official minutes
FDA – normally won’t comment on sponsor’s draft … unless it reflects major differences in view of meeting’s outcomes
If major differences identified, sponsor should raise these with the review division initially

54. “Formal Meeting” Guidance – Dispute Resolution
Clarifications – contact project manager to arrange teleconference
Changes –letter to Division Director, with a copy to the Project Manager, citing requested change & reason
 -- give project manager head’s up you’re pursuing this
Project manager issues response in writing
Changes agreed to by FDA – an addendum
Sponsor – if still not happy, pursue dispute resolution

55. THE DIFFERENT MEETINGS
Part 3
THE DIFFERENT MEETINGS

56. When to meet with FDA? What FDA suggests (see yellow “♦”)
Source: Regulatory Review of New Drugs, Carol Cavanaugh, CDER, presented at MLA 2004, Washington, DC, May 24, 2004

57. The Pre-IND Meeting
FDA – tries to limit to those surrounding innovative or unique development situations -- usually appropriate to discuss:
New chemical entities
First in class
Novel mechanism of action or indication
Situations lacking current guidance
Fast Track, Accelerated, Orphan Drug Designations
Regulatory mechanisms – e.g., 505(b)(2)
Problematic pharm/tox signals
Serious or life threatening disease target
New sponsor or new to area of drug development
Significant sponsor questions

58. The Pre-IND Meeting …
Ensure appropriateness and adequacy of pre-clinical studies to support proposed clinical
Submission formats
Electronic
Common technical document (CTD)

59. The Pre-IND Meeting – Meeting Package
Detail on product and product characteristics
Proposed clinical trials
API, raw materials, components, grades, and release specifications
Summary of manufacturing process
Narrative, flow chart, contamination control
in-process controls and specs
final product specs
 -- be careful to not box yourself in here

60. The Pre-IND Meeting – Meeting Package …
Summary of preclinical data
Summary of previous human experience
Questions by discipline, focusing on:
PK/PD
ADME
Dosing
Manufacturing (CMC)
Clinical development plan

61. The Pre-IND Meeting – Some FDA Hotpoints
Chemistry (CMC)
Don’t skimp on information
Note – if CMC issues are very numerous, FDA guidance contemplates ability for a separate meeting on those
See IND Meetings for Human Drugs and Biologics -- Chemistry, Manufacturing and Controls Information, May
State your IND will comply with CMC expectations in the two IND guidances:
Content and Format of IND application for Phase 1 Studies of Drugs
INDs for Phase 2 and Phase 3 Studies CMC Information

62. The Pre-IND Meeting – Some FDA Hotpoints … The CMC
Discuss:
Physical, chemical and/or biological characteristics
Manufacturers
Source and method of preparation
Removal of toxic reagents
Quality Controls (identity, assay, purity, impurities profile)
Formulation
Sterility (e.g., aseptic, release, endotoxin testing)
Linkage of pharm/tox batches to clinical trial batches
Stability
Drug delivery systems (if non-conventional)

63. The Pre-IND Meeting – Some FDA Hotpoints … CMC
Biologics & CMC
include characterization of master and working cell banks
Human source drugs –
donor screening
Removal of adventitious agents
Potency assay
Source, country of origin of animal derived materials
Immunogenicity – assays for
Comparability – physiochem characterization

64. The Pre-IND Meeting – Some FDA Hotpoints …
CMC Microbiology – address sterility considerations for products applied to open wounds & lesions
Pharm/Tox
505(b)(1) vs. (b)(2) – can impact nonclinical needs
Adequately characterize excipients’ toxicity
Rationale for starting dose, dose escalation
ADME data
Relevance of animal species, including nonhuman primates
Address significant findings – e.g., animal deaths

65. The Pre-IND Meeting – Some FDA Hotpoints …
Clinical Microbiology
Must conduct micro studies in accord with recent methods and standards
Include supportive documentation on spectrum of activity against targeted pathogens
Include exposure-antimicrobial activity relationship for relevant pathogens
Have clinical micro questions

66. The Pre-IND Meeting – Some FDA Hotpoints …
Clinical
Avoid seeking EOP2 commitments too early
Consider use of bridging studies for many formulation changes (especially for topicals)
Heed exposure-response relationships for safety and effectiveness
Volunteers v. target population
Stopping rules
Immunogenicity assessment, banked serum

67. The Pre-IND Meeting – Some FDA Hotpoints …
General
Pediatric development plan
Quality of life assessments
Don’t include new information as “updates” to briefing package
Sources: (1)“An FDA Approach to the Pre-IND Meeting Between a Sponsor and the Agency.” Jonathon Wilkin, MD, Director, Division of Dermatological and Dental Products, CDER, presented at DIA Annual Meeting, 2004.
(2) “The Biological Pre-IND Meeting.” Karen D. Weiss, M.D., Office of Drug Evaluation VI, CDER, presented at DIA Annual Meeting, 2004.

68. End of Phase 1 (EOP1) Primarily for Fast Track products
To discuss Phase 2 controlled trials for drugs aimed at life threatening/severely debilitating conditions
Goal – agreement on study design including statistical plan

69. End of Phase 2A (EOP2A) New meeting type – is a pilot program
Usually involves CDER Office of Pharmacology and Biopharmaceutics
Aim – exposure-response data
Impact – determines continuance or additional Phase 2 trials

70. End of Phase 2 (EOP2)
Goal – discuss and secure agreement on Phase 3 studies design
To support indications
Safety data
Monitoring requirements
Pediatric requirements
Other FDA concerns

71. End of Phase 2 (EOP2) … Common issues discussed: Clinical trial design
Chemistry – formulation, stability, impurities
Unique physicochemical (e.g., polymorphs) and biological properties
Starting material designation
Dissolution test procedures & coordination with agency
[for more examples, see pages 6-8 of Guidance on IND Meetings, CMC, cited on Slide 61].
ClinPharm: drug interactions, special populations, food effects
PharmTox: new findings (if any) from chronic or carcinogenicity studies

72. End of Phase Meetings -- Briefing Packages
Summary of clinical data (safety & effectiveness)
Rationale for additional studies
Proposed next study(s)
Detailed description of product and manufacturing processes, including:
Changes in formulation, scale, material sources, etc.

73. Pre-NDA/BLA Meeting To discuss:
Evidence of effectiveness
Any additional statistical analyses needed/requested by FDA
Need for risk management in indication
Technical aspects
Timing – 6 to 12 months before anticipated filing (per Good Review Management Guidance)

74. Pre-NDA/BLA Meeting …
Before requesting, assess whether application is ready to be filed
All clinical data in and evaluated
All previous advice implemented or, if not, agreed approach to address the issue
Facility – ready for pre-approval inspection
ready for full scale-up
Equipment, methods, and processes validated

75. Pre-NDA/BLA Meeting – Briefing Package
Similar to EOP meetings, but with more detailed manufacturing info
Emphasis on any changes and plans for “linkage”
Site, synthesis, controls, formulation, components, etc.
Summary of pivotal trials to support NDA/BLA approval
Identify primary endpoints
Proposed post-marketing risk management plan
Stability protocol
Proposed format (e vs. hard copy vs. CTD)

76. Pre-NDA/BLA Meeting – Briefing Package …
Contract manufacturer (if applicable) – identify and justify
Proposed submission timeline
Questions –
NDA/BLA contents
Any unresolved or new issues
Discuss strengths and weakneses

77. Pre-NDA/BLA Meeting – Some FDA Hotpoints
Viewed as primarily organizational and to discuss last minute issues
Thus, most scientific and potential review issues should have been settled already
ORM Division determines if meeting is discipline specific
Remember – this can be key to avoiding a later refuse-to-file on the NDA and delays in the review cycle

78. Special Protocol Meetings
Creature of FDAMA -- Implement § 119(a)
Covered studies:
Phase 3 trials to support an effectiveness claim – if discussed at the EOP2 meeting (or FDA knows the developmental context)
Animal carcinogenicity studies –
also should be discussed at EOP2 meeting
If not, notify division director 30 days before submitting request
Stability studies
Request for Assessment required, including the protocol
FDA has 45 days to review – sends letter
If you want a meeting after receiving that letter, handled as a Type A meeting

79. PART 4
TIPS & TRAPS

80. Meeting Goals – Direct and Indirect
Educate FDA about product, development and clinical efforts, technical expertise
Facilitate a successful and fast NDA/BLA review and approval
Address agency concerns as early as possible
Avoid delays due to need to correct or add to developmental plans
Gain FDA “buy-in” on overall strategy

81. When to Request a Meeting
Be sure you are ready
If requested and granted and you can’t be ready, cancel or reschedule
Will start cycle over, but you don’t want to waste agency time

82. Questions for Meetings
Key to process – frame with great care
Avoid overbroad and open-ended questions
Be specific and answerable (if possible)
Provide supporting information to allow question to be answered (if possible)
Provide the answer in the question – lead the witness (if possible)
Example: “Does the agency agree that one, multi-center study, with separately-analyzable data, is sufficient to support approval of the indication?”

83. Meeting Preparation – Essential!!
Know the Briefing Package cold (as many folks as possible should do this)
Know relevant statutes, regulations and guidance
Know your product and its capabilities and faults
Rehearse – more than once, if possible
Use a pre-meeting team to play the FDA roles (hire outside consultants if needed)
Night before – get hotel close to FDA (D.C. area traffic is terrible)

84. Meeting Preparation – Essential …
Prepare for alternative approaches and fallback positions in advance
Define roles
Company lead (often R.A.)
Role of CEO – usually to listen; unless has substantive expertise (e.g., in small start-ups)
Subject matter experts – must stick to their areas
Scribe – dedicated solely to taking notes, with stress on:
FDA questions
FDA recommendations

85. Meeting Preparation – Essential …
Be persuasive, but open & honest
Do not speculate
Do not hide information – the last thing you want is for FDA to find out about a negative issue
Be succinct – no “dog and pony” shows
Focus on Q&A
Do not interrupt
Watch your humor

86. Meeting Preparation – Essential …
Don’t promise anything that you are not prepared to do –
Acknowledge the issue
defer if needed – “…take it into consideration”
Don’t include any off-agenda items – avoid surprise
Don’t bring anyone not on the list (e.g., an attorney)
Don’t debate policy -- unless it is clearly on the agenda and has been “briefed” – rarely will be addressed in these types of meetings

87. After the Meeting Debrief ASAP
 -- if public company, assess immediately if any SEC disclosure duties implicated by meeting
Prepare your minutes ASAP and route internally
get to FDA Project Manager ASAP (within 7 days)
Review and address FDA minutes (as discussed previously)
Correction requests should be based on significant differences in understanding;
disagreements are usually bound for dispute resolution mechanisms

88. Causes of Unsuccessful Meetings
Inadequate planning and coordination
Poor preparation
Incomplete or inadequate information
Confrontations
Poor communication
Not providing all relevant information
Lack of candor
Poor questions

89. Causes of Unsuccessful Meetings …
Stressing commercial or corporate concerns over science
Failure to follow up on action items or advice, even if not in formal minutes (but try to get it in there)
Not adequately documenting agreements, decisions, commitments
By-passing chain of command

90. PART 5
Q & A

91. Michael A. Swit, Esq. FDACounsel.com
Questions?
Write, call, fax or
Michael A. Swit, Esq. FDACounsel.com
THE LAW OFFICES OF MICHAEL A. SWIT
539 Samuel Ct., Suite 229
Encinitas, CA 92024
office: ♦ fax:

92. About your instructor
Michael A. Swit has over 20 years of experience addressing critical FDA legal and regulatory issues. His vast and varied experience, which he is now providing as a solo practitioner, includes serving for three and a half years as vice president and general counsel of Pharmaceutical Resources, Inc. (PRI) a prominent generic drug manufacturer through its Par Pharmaceutical subsidiary. He thus also brings an industry and commercial perspective to his representation of FDA-regulated companies and, to that, effect also counsels on an array of transactional issues relating to FDA-regulated biomedical industry, including clinical research agreements, mergers & acquisitions, contract manufacturing, and due diligence inquiries.
While at PRI from 1990 to late 1993, Mr. Swit spearheaded the company’s defense of multiple grand jury investigations, other federal and state proceedings, and securities litigation stemming from the acts of prior management. Mr. Swit then served from 1994 to 1998 as CEO of Washington Business Information, Inc. (WBII) a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA-regulated community. From May 2001 to May 2003, Mr. Swit was special counsel in the FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe. Before that, he was twice in private practice with McKenna & Cuneo, from 1988 to 1990 and, most recently, from 1999 to 2001, first in that firm’s D.C. office and most recently, in its San Diego office. He first practiced FDA regulatory law with the D.C. office of Burditt & Radzius from 1984 to Mr. Swit has taught and written on a wide variety of subjects relating to FDA law including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. He is a member of the California, Virginia and District of Columbia bars.

93. Acknowledgements
The speaker gratefully acknowledges the help of Dan Klassen of Parexel whose recent presentation before the San Diego Regulatory Affairs Network (“SDRAN”) formed the basis for parts of this presentation.