1. Report Summary: Building an Effective Regulatory Relationship with the FDA
Building an Effective Regulatory
Relationship with the FDA
PROJECT BACKGROUND Benchmarking Report
at-a-Glance
Behind every successful New Drug Application is an
effective relationship involving representatives of the Featured Study Participants
pharmaceutical industry and the U.S. Food and Drug • Alcon
Administration. While the fate of an NDA is tethered to its • Amgen
science, how effectively the application wends its way • AstraZeneca
• Bayer
through the regulatory labyrinth is linked to what kind of
• Boehringer Ingelheim
formal and/or informal working relationship exists between a • Bristol-Myers Squibb
sponsor and the FDA. • Eli Lilly & Co.
• Genentech
Effective interactions during the NDA process are no small • Medtronic
• Merck
matter with ineffective communication costing an NDA
• Novartis
precious review time and worse, possibly an approval. • Roche
Approval delays can translate into millions in lost sales • Solvay
while a “complete response” letter can mean a top-line loss • United Therapeutics
of hundreds of millions. • Valeant
• Wyeth
Pharmaceutical companies with good track records of
Industry Analysis
approvals and first approvals are characterized not only by
strong science but also strong working relationships with the 16 benchmark companies representing
the biopharmaceutical industry
FDA. Still, there is no manual on how to build an effective, participated in this study.
collegial relationship with FDA directors, project managers
and reviewers. Information Types
• 8 Information Graphics
The pharmaceutical industry uses Regulatory Affairs as its • 27 Data Graphics
main point of contact with the FDA. But organizations • 300 Metrics
approach the subject of relationships – which is a sensitive • 50+ Executive Narratives
one for both the industry and agency in terms of public
perception – differently and with strong concepts of what
Report Length
works and what doesn’t work. • 80 pages
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2. Report Summary: Building an Effective Regulatory Relationship with the FDA
This report delivers benchmarks and insights that identify effective interaction approaches for
understanding and working with the FDA. Regulatory Affairs executives and managers can use
this research to build better working relationships with the FDA by comparing their
communication methods and policies with the practices of leading pharmaceutical companies.
The research looks at how organizations can strengthen working relationships with the FDA by
probing a number of key elements of their Regulatory Affairs office, including:
• Organizational structure and alignment
• Regulatory skill sets
• Relationship management
• Planning for critical FDA meetings
• Understanding FDA culture
STUDY METHODOLOGY
This report is based on Best Practices, LLC research involving regulatory executives and
managers from pharmaceutical companies and one medical device firm as well as information
from the Food and Drug Administration and other agencies and industry associations.
The research employed a two-pronged data gathering approach that gleaned quantitative data
from a detailed survey and qualitative data from in-depth interviews with regulatory leaders at
pharmaceutical companies and inside the industry to harvest insights and lessons learned on
building an effective regulatory relationship with the FDA.
SAMPLE FINDINGS
Among the findings that emerged from this research are the following:
• Organizational Structure and Location: Four-fifths of all companies in this
research are either a U.S.-based company that places oversight of FDA interactions
within headquarters or are companies not based in the U.S. that place such oversight
with their U.S. subsidiary offices. No benchmarked companies use a decentralized
structure as this would hinder oversight of corporate FDA interactions. Nearly two-
thirds of the benchmark partners are highly centralized in how they oversee FDA
interactions.
Most research respondents see an advantage to mirroring their own staff structure to
that of the FDA in regard to those groups or functions that interact with the agency.
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3. Report Summary: Building an Effective Regulatory Relationship with the FDA
• The FDA and the Washington Ecosystem: Take note of personnel and
divisional idiosyncrasies within the FDA: positive and negative interactions in one
place can have ripple effects for your NDA in other parts of the agency.
Avoid level-skipping to accelerate a decision. Level-skipping can cause longer-term
resentment, distrust and harm to your NDA within the FDA.
• Skill Sets & Capabilities: Most Regulatory staffs have few former FDA
employees, let alone former top-level FDA employees. Some research participants said
that only former agency officials who were highly placed in the administration will
benefit organizations when it comes to working with the FDA, citing a tendency in
lower-level former FDA employees toward bureaucracy.
• Planning and Preparation for the NDA: Eighty percent of benchmark
partners see the designation of a single point of contact for FDA communications
during the NDA process as the most effective approach to creating and maintaining
successful interactions with the agency.
• Safety and Risk Management: Consider hiring more safety experts to address
new FDA safety priorities.
Review Risk Evaluation and Mitigation Strategy section of Food and Drug
Administration Amendments Act of 2007 and be prepared to talk about issues
surrounding target populations and indications (labeling) earlier in the NDA process as
a result of the legislation.
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4. Report Summary: Building an Effective Regulatory Relationship with the FDA
DATA SECTION EXCERPTS
Working with the FDA (an Excerpt)
Survey responses and interviews with Regulatory Affairs executives with leading
pharmaceutical companies revealed that relationship building through formal channels and on a
personal level, is the No. 1 lesson for more successful FDA interactions.
Top Methods for Working With the FDA
Pharmaceutical companies noted that building strong formal relationships with the FDA and
utilizing external communication techniques are Integral to the success of working with the FDA.
Share your top three “lessons Learned” in forging productive FDA working relationships
that help move your NDAs without unnecessary delays or surprises though the agency's
review process.
Formal
Relationships
Formal Relationships with FDA 26%
with FDA
Meeting External Communication with FDA 26%
Informal Planning,
Relationships Preparedness,
with FDA Meeting Planning, Preparedness
Field Lessons Productivity 24%
and Productivity
External
Informal Relationships with FDA 21%
Internal
Communication
Communication
with FDA
Internal Communication 3%
% of Companies
N=38 (13 companies provided 2-3 lessons learned)
Copyright© Best Practices®, LLC BEST PRACTICES, ®
LLC
Figure 1: Top Methods for Working with the FDA
The Role of Reputation (an Excerpt)
Regulatory leaders for Top 10 companies spoke of the value of transparency in interactions with
the agency and working as partners with the FDA during the review process. That approach was
also championed by the former Deputy Commissioner who participated in this research.
“Companies need to err on the side of being uniformly transparent,” the former deputy
commissioner said. “Companies need to develop a reputation for good pharmacovigilance. If
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5. Report Summary: Building an Effective Regulatory Relationship with the FDA
you have a good reputation, you can convince FDA on science, not political pressure. Most of
the big pharmaceutical companies have these reputations that permeate the agency.”
Many companies felt that Merck has the best reputation in the industry for guiding NDAs
through the agency approval process. The former FDA Deputy Commissioner echoed that
sentiment, saying the agency looks favorably on the company because of its science and
pharmacovigilance programs.
Pharmas Most Admired for FDA Navigation Skills
In terms of moving NDAs through the regulatory process, Merck and Pfizer have the best
reputations among benchmark partners.
Rank your top 5 Pharmaceutical companies that you most admire for moving NDAs
through the FDA regulatory process.
Merck 45
Pfizer 32
GSK 29
Novartis 26
Eli Lilly 21
J&J 13
BMS 13
AstraZeneca 9
Wyeth 7
Roche 5
Sanofi-Aventis 2
Schering-Plough 2
Rating (Maximum Score=70)
N=14
Copyright© Best Practices®, LLC BEST PRACTICES, ®
LLC
Figure 3.1: Pharmas most admired for FDA navigation skills
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6. Report Summary: Building an Effective Regulatory Relationship with the FDA
REPORT STRUCTURE AND ORGANIZATION
The research findings are organized into this executive summary with best practice chapters
supported by survey data and charts.
Executive summary: The executive summary contains a project overview, information about
the participant companies and a summary of key findings.
Best Practice Chapters: This section provides an analysis of the survey data along with detailed
best practices uncovered in the participant interviews.
• Chapter One: Structure and Rockville Satellite Office
• Chapter Two: Building Effective Relationships
• Chapter Three: Working with and Understanding the FDA and
Washington Ecosystem
• Chapter Four: Skills Capabilities and Competencies for Success
• Chapter Five: Planning and Preparation for the NDA
• Chapter Six: Safety and Risk Management
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7. Report Summary: Building an Effective Regulatory Relationship with the FDA
TABLE OF CONTENTS
Executive Summary ....................................................................................................................... 6
PROJECT BACKGROUND.............................................................................................................. 6
RESEARCH METHODOLOGY........................................................................................................ 6
KEY FINDINGS................................................................................................................................ 7
THE BENCHMARK CLASS ........................................................................................................... 11
REPORT STRUCTURE AND ORGANIZATION............................................................................ 11
Structure and Rockville Satellite Office Overview.................................................................... 14
ORGANIZATIONAL STRUCTURE ................................................................................................ 15
CENTRALIZATION OF FUNCTION .............................................................................................. 17
ROLE OF ROCKVILLE SATELLITE OFFICE................................................................................ 20
Building Effective Relationships ................................................................................................ 26
OVERVIEW.................................................................................................................................... 26
FORMAL RELATIONSHIPS .......................................................................................................... 27
INFORMAL RELATIONSHIPS....................................................................................................... 31
EMAILS VS. PHONE CALLS......................................................................................................... 33
ATTENDING CONFERENCES...................................................................................................... 34
Working with and Understanding the FDA and Washington Ecosystem .............................. 37
OVERVIEW.................................................................................................................................... 37
WORKING ON RELATIONSHIPS ................................................................................................. 38
THE ROLE OF REPUTATION....................................................................................................... 40
THE WASHINGTON ECOSYSTEM .............................................................................................. 42
Skills, Capabilities and Competencies for Success................................................................. 46
OVERVIEW.................................................................................................................................... 46
A DYNAMIC PROFESSION........................................................................................................... 47
SKILL SETS ................................................................................................................................... 47
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8. Report Summary: Building an Effective Regulatory Relationship with the FDA
SCIENCE VERSUS REGULATORY EXPERIENCE ..................................................................... 51
FDA EXPERIENCE........................................................................................................................ 54
PERFORMANCE MEASUREMENT .............................................................................................. 55
Planning and Preparation for the NDA ...................................................................................... 58
OVERVIEW.................................................................................................................................... 58
STARTING WITH THE NDA.......................................................................................................... 59
WHO SPEAKS, LEADS ................................................................................................................. 60
MINUTES ....................................................................................................................................... 61
WORKING WITH THE PROJECT MANAGER .............................................................................. 63
PREPARING FOR NDA MEETINGS............................................................................................. 64
MEETING REHEARSALS.............................................................................................................. 66
NEGOTIATING FOR A WIN-WIN WITH LABELING ..................................................................... 70
Safety and Risk Management ..................................................................................................... 70
OVERVIEW.................................................................................................................................... 73
REFOCUSING ON SAFETY.......................................................................................................... 74
RISK EVALUATION AND MITIGATION STRATEGIES ................................................................ 77
CHANGING SAFETY LANDSCAPE.............................................................................................. 78
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9. Report Summary: Building an Effective Regulatory Relationship with the FDA
TABLES AND FIGURES
Figure 1: Top Methods for Working with the FDA............................................................................ 7
Figure 2: Best Practices LLC benchmark Class ............................................................................ 11
Figure 1.1: Organizational oversight of FDA Function................................................................... 15
Figure 1.2: Companies choose to mirror FDA structure ................................................................ 16
Figure 1.3: Align your staff with their FDA peers ........................................................................... 17
Figure 1.4: Organizational Structure for FDA Interactions............................................................. 18
Figure 1.5: Regulatory oversees corporate FDA interactions........................................................ 19
Figure 1.6: More utilization of Rockville office possible ................................................................. 21
Figure 1.7: FDA focus Vital component of Rockville Offices ......................................................... 22
Figure 1.8: More Emphasis places on FDA Liaison Role .............................................................. 22
Figure 1.9: Key competencies needed in rockville ........................................................................ 24
Figure 2.1: Engagement Strategy for FDA Staff ............................................................................ 27
Figure 2.2: FDA Reviewers make Optimal partners ...................................................................... 28
Figure 2.3: Emails and Phone best ways to contact FDA.............................................................. 33
Figure 2.4: Email Used to build informal FDA relationships .......................................................... 34
Figure 3.1: Pharmas most admired for FDA navigation skills........................................................ 41
Figure 3.2: Biotechs Most Admired for FDA Navigation Skills....................................................... 42
Figure 4.1: RA Profession - Integral to Healthcare Product Lifecycle ........................................... 47
Figure 4.2: A matrix of characteristics can help in FDA work ........................................................ 48
Figure 4.3: Regulatory Knowledge is most valued trait ................................................................. 49
Figure 4.4: Legal/Regulatory background can help ....................................................................... 49
Figure 4.5: Regulatory or clinical Backgrounds Preferred ............................................................. 50
Figure 4.6: Balancing Backgrounds & skill sets............................................................................. 53
Figure 4.7: Hiring the right kind of FDA staff.................................................................................. 54
Figure 4.8: Companies have few staff with FDA experience ......................................................... 55
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10. Report Summary: Building an Effective Regulatory Relationship with the FDA
Figure 4.9: Regulatory uses Multiple Performances Metrics ......................................................... 56
Figure 5.1: The high quality NDA support Safety .......................................................................... 59
Figure 5.2: Gatekeeper Model Favored in FDA relationships........................................................ 63
Figure 5.3: Key Roles During NDA Process .................................................................................. 65
Figure 5.4: Companies divided about using outside expert........................................................... 66
Figure 5.5: Many ways to help prepare NDA presentations .......................................................... 68
Figure 5.6: Mock reviews core approaches for FDA prepration .................................................... 68
Figure 5.7: The draft label sets the tone ........................................................................................ 71
Figure 6.1: FDA continues to emphasize safety ............................................................................ 74
Figure 6.2: Safety-Based Withdrawals........................................................................................... 75
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11. Report Summary: Building an Effective Regulatory Relationship with the FDA
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