Abstract
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.
Industries Profiled:
- Pharmaceutical; Biotech; Consumer Products; Diagnostic; Manufacturing;
Health Care; Chemical
Companies Profiled:
- Alcon; Amgen; AstraZeneca; Bayer; Boehringer Ingelheim; Bristol-Myers
Squibb; Eli Lilly & Co.; Genentech; Medtronic; Merck; Novartis; Roche; Solvay;
United Therapeutics; Valeant; Wyeth
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
- Project Background
- Research Methodology
- Key Findings
- Figure 1 - Top Methods for Working with the FDA
- Benchmark Class
- Figure 2 - Best Practices LLC Benchmark Class
- Report Structure and Organization
STRUCTURE AND ROCKVILLE SATELLITE OFFICE
- Overview
- Organizational Structure
- Figure 1.1 - Organizational oversight of FDA Function
- Figure 1.2 - Companies choose to mirror FDA structure
- Figure 1.3 - Align your staff with their FDA peers
- Centralization of Function
- Figure 1.4 - Organizational Structure for FDA Interaction
- Figure 1.5 - Regulatory oversees corporate FDA interactions
- Figure 1.6 - More utilization of Rockville office possible
- Figure 1.7 - FDA focus vital component of Rockville offices
- Figure 1.8 - More emphasis placed on FDA liaison role
- Figure 1.9 - Key competencies needed in Rockville
BUILDING EFFECTIVE RELATIONSHIPS
- Overview
- Formal Relationships
- Figure 2.1 - Engagement strategy for FDA staff
- Figure 2.2 - FDA reviewers make optimal partners
- Informal Relationships
- Emails vs. Phone Calls
- Figure 2.3 - Emails and phone best ways to contact FDA
- Figure 2.4 - Email used to build informal FDA relationships
- Attending Conferences
WORKING WITH AND UNDERSTANDING THE FDA AND WASHINGTON ECOSYSTEM
- Overview
- Working on Relationships
- The Role of Reputation
- Figure 3.1 - Pharmas most admired for FDA navigation skills
- Figure 3.2 - Biotechs most admired for FDA navigation skills
- The Washington Ecosystem
SKILLS, CAPABILITIES, AND COMPETENCIES FOR SUCCESS
- Overview
- A Dynamic Profession
- Figure 4.1 - RA Profession - Integral to Healthcare Product Lifecycle
- Skill Sets
- Figure 4.2 - A matrix of characteristics can help in FDA work
- Figure 4.3 - Regulatory knowledge is most valued trait
- Figure 4.4 - Legal/Regulatory background can help
- Figure 4.5 - Regulatory or clinical backgrounds preferred
- Science versus Regulatory Experience
- Figure 4.6 - Balancing backgrounds and skill sets
- FDA Experience
- Figure 4.7 - Hiring the right kind of FDA staff
- Figure 4.8 - Companies have few staff with FDA experience
- Performance Measurement
- Figure 4.9 - Regulatory uses multiple performance metrics
PLANNING AND PREPARATION FOR THE NDA
- Overview
- Starting with the NDA
- Figure 5.1 - The high quality NDA support safety
- Who speaks, Leads
- Minutes
- Working with the Project Manager
- Figure 5.2 - Gatekeeper model favored in FDA relationships
- Preparing for NDA Meetings
- Figure 5.3 - Key roles during NDA process
- Figure 5.4 - Companies divided about using outside expert
- Meeting Rehearsals
- Figure 5.5 - Many ways to help prepare NDA presentations
- Figure 5.6 - Mock reviews core approaches for FDA preparation
- Negotiating for a Win-Win with Labeling
- Figure 5.7 - The draft label sets the tone
SAFETY AND RISK MANAGEMENT
- Overview
- Refocusing on Safety
- Figure 6.1 - FDA continues to emphasize safety
- Figure 6.2 - Safety-Based withdrawals
- Risk Evaluation and Mitigation Strategies
- Changing the Safety Landscape
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