Building An Effective Regulatory Relationship with The Fda

Publication Date	February 2009
Publisher	Best Practices
Product Type	Report
Pages	80
ISBN Number	not applicable
Product Code	BPC00064

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Summary

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.

Content

Executive Summary
- Project Background
- Research Methodology
- Key Findings
- Benchmark Class
- Report Structure and Organization
Structure and Rockville Satellite Office
- Overview
- Organizational Structure
- Centralization of Function
Building Effective Relationships
- Overview
- Formal Relationships
- Informal Relationships
- Emails vs. Phone Calls
- Attending Conferences
Working with and Understanding The Fda and
Washington Ecosystem
- Overview
- Working on Relationships
- The Role of Reputation
- The Washington Ecosystem
Skills, Capabilities, and Competencies for Success
- Overview
- A Dynamic Profession
- Skill Sets
- Science versus Regulatory Experience
- FDA Experience
- Performance Measurement
Planning and Preparation for The Nda
- Overview
- Starting with the NDA
- Who speaks, Leads
- Minutes
- Working with the Project Manager
- Preparing for NDA Meetings
- Meeting Rehearsals
- Negotiating for a Win-Win with Labeling
Safety and Risk Management
- Overview
- Refocusing on Safety
- Risk Evaluation and Mitigation Strategies
- Changing the Safety Landscape
List of Figures
- Figure 1 - Top Methods for Working with the FDA
- Figure 2 - Best Practices LLC Benchmark Class
- 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
- 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
- Figure 2.1 - Engagement strategy for FDA staff
- Figure 2.2 - FDA reviewers make optimal partners
- Figure 2.3 - Emails and phone best ways to contact FDA
- Figure 2.4 - Email used to build informal FDA relationships
- Figure 3.1 - Pharmas most admired for FDA navigation skills
- Figure 3.2 - Biotechs most admired for FDA navigation skills
- Figure 4.1 - RA Profession - Integral to Healthcare Product Lifecycle
- 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
- Figure 4.6 - Balancing backgrounds and skill sets
- Figure 4.7 - Hiring the right kind of FDA staff
- Figure 4.8 - Companies have few staff with FDA experience
- Figure 4.9 - Regulatory uses multiple performance metrics
- Figure 5.1 - The high quality NDA support safety
- Figure 5.2 - Gatekeeper model favored in FDA relationships
- Figure 5.3 - Key roles during NDA process
- Figure 5.4 - Companies divided about using outside expert
- Figure 5.5 - Many ways to help prepare NDA presentations
- Figure 5.6 - Mock reviews core approaches for FDA preparation
- Figure 5.7 - The draft label sets the tone
- Figure 6.1 - FDA continues to emphasize safety
- Figure 6.2 - Safety-Based withdrawals