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Building an Effective Regulatory Relationship with the FDA

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8	Info Graphics
27	Data Graphics
300	Metrics
50	Narratives

Pages: 80

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Building an Effective Regulatory Relationship
with the FDA

ID: OP-104

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Though science remains the fundamental engine behind successful New Drug Applications, effective communication between pharmaceutical companies and the FDA at each stage of this process stands as a vital ingredient in securing approval for a new therapy.

Applicant companies that frequently gain approval and first approvals – and avoid delays or, worse, the nebulous and costly “complete response” letter – brandish not only good science but also cultivate and sustain strong working relationships with the FDA and its staff.

The topic of informal working relationships between pharmaceutical representatives and the FDA is a sensitive one for all parties. Regulatory officials in pharma hold distinct views on what characterize effective communication strategies and tactics with the agency.

This report delivers benchmarks and insights that identify approaches for understanding and effectively interacting with the FDA. The research is based on detailed survey data from Regulatory Affairs executives and managers from 15 top pharmaceutical companies. The report includes insights gleaned from interviews with 13 Regulatory executives who boast extensive experience with NDAs and the FDA.

Benchmark Class
Study Snapshot
Key Findings
View TOC and List of Exhibits

Industries Profiled:
Medical Device; Biotech; Pharmaceutical; Manufacturing; Consumer Products; Diagnostic; Chemical; Health Care

Companies Profiled:
Alcon; Amgen; AstraZeneca; Bayer; Boehringer Ingelheim; Bristol-Myers Squibb; Eli Lilly & Co.; Genentech; Medtronic; Merck; Novartis; Roche; Solvay; United Therapeutics; Valeant

Study Snapshot

Regulatory Affairs executives and managers will benefit from research that focuses on the following major topic areas:

Organizational Structure and Alignment
Discusses placing oversight of FDA interactions within U.S.-based Regulatory Affairs office, aligning Regulatory staff structure to reflect the structure of key FDA offices and divisions, and keeping Regulatory as the centralized leader in all interactions with the FDA

Regulatory Skills Sets and Capabilities
Examines Science versus Regulatory experience in filling key positions and the process of integrating multiple backgrounds and skill sets into Regulatory’s talent pool

Understanding the FDA and the Washington Ecosystem
Discusses the role of personnel and divisional idiosyncrasies within the FDA, the importance of following chain of command when working with the FDA, and the value of establishing a positive reputation with the FDA and in Washington

Building Effective Relationships
Outlines the optimal parameters for both formal and informal relationships with the FDA, including best channels for communication and ongoing dialogue

Planning and Preparation for the NDA
Details effective preparation for the NDA, Regulatory and Clinical collaborative strategy, and the development of sound negotiation positions and operational leadership

Safety and Risk Management
Evaluates ways to manage FDA concerns and examines the changing safety landscape

Key Findings

Organizational Structure:
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.

Hiring for Regulatory Affairs:
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.

Managing an NDA:
Avoid level-skipping to accelerate a decision. Level-skipping can cause longer-term resentment, distrust and harm to your NDA within the FDA. In addition, 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.

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

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

List of Charts & Exhibits

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

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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