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Building an Effective Regulatory Relationship with the FDA
Best Practices LLC, Feb 2009, Pages: 80
This report delivers benchmarks and insights that identify approaches for understanding and effectively interacting with the FDA.
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.
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.
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