Building Effective FDA Relationships and Working with Regulators

STUDY OVERVIEW

New Drug Applications produce new products - the lifeblood of the pharmaceutical industry. In addition to strong science, NDAs need effective Regulatory Affairs groups to help them navigate the regulatory labyrinth that is the U.S. Food and Drug Administration. To ensure successful interactions with the FDA, officials in Regulatory Affairs groups need to establish and cultivate both formal and informal relationships with agency officials.
This study examines what communication approaches foster effective relationships between Regulatory Affairs groups and the FDA and the importance of maximizing agency interactions. Additionally, this research explores valuable tactics for working with the FDA and the importance of understanding the Washington, D.C. ecosystem.
Regulatory leaders can use the insights from this research to inform their communication approaches with regulatory officials and to compare their group’s tactics for working with the agency on filings.

KEY TOPICS

• Executive Summary
• Formal Relationships
• Informal Relationships
• Email vs. Phone Calls
• Attending Conferences
• Working on Relationships
• The Role of Reputation
• The Washington Ecosystem

KEY METRICS

• Top Methods for Working with the FDA
• Effectiveness of Engagement Strategies for FDA Staff
• Ranking of FDA Organizational Levels Most Effective to Deal With
• Rating of Informal Approaches for Building Relationships
• Ranking of Informal Approaches for Building Relationships
• Reputational Ranking of Top 5 Pharma Companies
• Reputational Ranking of Top 5 Biotech Companies

SAMPLE KEY FINDINGS

• Develop customized relationship strategies that reflect the different needs and styles of each director and FDA office. Different offices have strikingly different styles and requirements.
• 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.

METHODOLOGY

The research employed a data gathering approach that gleaned quantitative data from 15 biopharma companies and one medical device company through a detailed survey. In addition, 13 Regulatory leaders participated in in-depth interviews.

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