March 2, 2009 Webinar presented by The Weinberg Group, with a focus on: ƒ What to expect from an FDA meeting ƒ Key points to keep in mind when preparing for the meeting ƒ Understanding the difference between discussion, debate and negotiation ƒ Techniques for preparing for “embarrassing” questions ƒ A little bit about the meeting ƒ Tips for the immediate post-meeting period

1. The Top Ten Ways to Ensure Successful FDA Meetings
Presented by:
Joel I. Falk, Executive Vice President
Michael A. Swit, Esq., Vice President
Moderated by:
Jeff Antos, Vice President
March 2, 2009

2. Michael A. Swit, Esq.
Vice President
Encinitas, CA
+1 760.633.3343
+1 760.633.3501 (fax)
michael.swit@weinberggroup.com
Today's Presenters
Joel I. Falk
Executive Vice President
Washington, DC
+1 202.730.4126
+1 202.833.7057 (fax)
joel.falk@weinberggroup.com
Mr. Falk has 35 years of experience in the pharmaceutical industry and has
been instrumental in more than 20 major drug submissions in the United
States and abroad in a variety of therapeutic areas. He has responsibility
for the management of clinical research, data management,
pharmacovigilance and pharmaceutical product defense issues for large
and small drug firms.
Mr. Swit has been addressing critical FDA legal and regulatory issues since
1984. His expertise includes product development strategies, compliance
and enforcement initiatives, recalls and crisis management, FDA regulatory
activities, labeling and advertising, and clinical research efforts. Mr. Swit
develops and ensures the execution of a broad array of regulatory and other
services to clients, both directly and through outside counsel.
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3. What to expect from an FDA meeting
Key points to keep in mind when preparing for the meeting
Understanding the difference between discussion, debate
and negotiation
Techniques for preparing for “embarrassing” questions
A little bit about the meeting
Tips for the immediate post-meeting period
Our Goals Today
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4. Areas of concern include:
Science
Medicine
Ethics
Regulations
Know your goals before you request the meeting
Be aware of the timing of the request and the availability
of materials
3
# 1: Be Prepared
(If you’re not, you won’t know what hit you)
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5. Understand your position and, at the very least, the basic
requirements
Know who you’re talking to –
Precedent and predisposition
Recent attitudes towards similar issues
Diligently plan to achieve your major objectives
Know your strong points very well
Know your weak points even better
4
#2: Be Knowledgeable
(Don’t be dumb…Don’t play dumb)
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6. Ask an open question, receive an open (and often useless)
answer
Ask all of the questions for which you need answers
Questions should be clear, concise and supportable
State issues positively and assuredly
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# 3: Be Confident and Thorough
(Ask for the moon.)
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7. Good negotiation techniques help
Know your BATNA
There is no such thing as a one-way compromise
Evaluate the overall cost of winning on small points
Do not be combative
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#4: Be Cooperative
(There is no real payoff for winning a single battle)
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8. Try to be unemotional and critical about your product
What do you see? That’s what the regulators are looking at
Being objective allows you to be better prepared
The very embarrassing “Tiger Team” approach
FDA often answers your questions in writing prior to the
meeting – but you still need to be prepared
7
#5: Know Your Flaws
(Believe me you’ve got them and the FDA knows it too)
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9. Sample “Tiger Team” Prep. Worksheet
8
Sponsor Question
Potential Agency Response
To Be Answered by Support
Potential Sponsor Follow up
Type of Meeting – Date Name of Sponsor
REGULATORY AGENCY Q & A WORKSHEET
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10. The purpose of the meeting is to get useful and complete
information
The regulatory advice you will get will only be as honest as
the data presented
Be honest about what you don’t know
If appropriate, commit to finding out the answers
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#6: Be Honest
(Being haunted by a half-truth told to the FDA is not fun)
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11. Advantages to a successful FDA meeting
Generally only one chance to get feedback on particular issues
Time and cost savings for doing things once and right
Building a proper, collegial relationship with the Agency
creates better and smoother communication for all issues
Listen very carefully – it’s important to understand
everything
Stick to the point - avoid temptation to be irrelevant and
show how much else you know
10
#7: Be Serious, Seriously
(Do you know why they don’t send donkeys to college?)
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12. Key to process – frame with great care
Avoid overbroad and open-ended questions
Be specific and answerable
Suggest 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?”
Briefing package – provide detailed supporting information to
allow question to be answered – will need to be substantially
complete even before you submit
#8: Before The Meeting – The Questions
and Meeting Package
(Writing the script …)
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13. Define roles in Advance – see “Tiger Team” slide
Company lead – should have comprehensive view of issues
Subject matter experts (e.g., therapeutic area, statistics, clinical
pharmacology, toxicology, etc.) as appropriate
Non-scientific senior management
Usually to listen; unless has substantive expertise (e.g., in small start-ups)
Scribe – dedicated solely to taking notes, with stress on:
FDA questions
FDA recommendations
Understand your authority to commit on behalf of your firm
Be sure to clear all attendees prior to the meeting
Rehearse, Rehearse, Rehearse
#9: Casting the Show – Your Actors
(All the world may be a stage, but not everyone gets to act)
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14. Don’t include any off-agenda items – avoid surprises
Don’t debate policy unless it is clearly on the agenda and has
been “briefed” – rarely is it addressed in these types of
meetings
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
Don’t stress commercial or corporate concerns over science
Summarize agreements at end
#10: At The Meeting – Stick to The Script
(This is not the Improv)
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15. Debrief ASAP
If public company, immediately assess if any SEC disclosure
duties triggered by meeting
Prepare your minutes ASAP and route internally
Get to FDA project manager ASAP (typically within 7 days)
Review and address FDA minutes
Correction requests should be based on significant differences
in understanding
Disagreements – use correct dispute resolution mechanisms –
pursue via chain of command, unless an Ombudsman issue
Keep your commitments
#11: After The Meeting
(Sorry, but this is no time to party)
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16. Much is to be gained from a successful Agency meeting
Ask and answer issues in a scientific and data-driven manner
Deliberate and thoughtful preparation is key
Be mindful of your weak points
Stay on message
Conclusions
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17. Pharmaceutical Development in the EU – Key Points to Consider
A Webinar Presented by The Weinberg Group
Wednesday, April 15, 2009
12 p.m. (ET) | 11 a.m. (CT) | 10 a.m. (MT) | 9 a.m. (PT)
Presented by:
Peter Cooper, Ph.D.,Vice President
Angus Cameron, Senior Director
Edinburgh, United Kingdom
Upcoming Webinar