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Building an Effective Regulatory Relationship with the FDA Report Summary

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Building an Effective Regulatory Relationship with the FDA Report Summary

  1. 1. Report Summary: Building an Effective Regulatory Relationship with the FDABuilding an Effective RegulatoryRelationship with the FDAPROJECT BACKGROUND Benchmarking Report at-a-Glance Behind every successful New Drug Application is an effective relationship involving representatives of the Featured Study Participants pharmaceutical industry and the U.S. Food and Drug • Alcon Administration. While the fate of an NDA is tethered to its • Amgen science, how effectively the application wends its way • AstraZeneca • Bayer through the regulatory labyrinth is linked to what kind of • Boehringer Ingelheim formal and/or informal working relationship exists between a • Bristol-Myers Squibb sponsor and the FDA. • Eli Lilly & Co. • Genentech Effective interactions during the NDA process are no small • Medtronic • Merck matter with ineffective communication costing an NDA • Novartis precious review time and worse, possibly an approval. • Roche Approval delays can translate into millions in lost sales • Solvay while a “complete response” letter can mean a top-line loss • United Therapeutics of hundreds of millions. • Valeant • Wyeth Pharmaceutical companies with good track records of Industry Analysis approvals and first approvals are characterized not only by strong science but also strong working relationships with the 16 benchmark companies representing the biopharmaceutical industry FDA. Still, there is no manual on how to build an effective, participated in this study. collegial relationship with FDA directors, project managers and reviewers. Information Types • 8 Information Graphics The pharmaceutical industry uses Regulatory Affairs as its • 27 Data Graphics main point of contact with the FDA. But organizations • 300 Metrics approach the subject of relationships – which is a sensitive • 50+ Executive Narratives one for both the industry and agency in terms of public perception – differently and with strong concepts of what Report Length works and what doesn’t work. • 80 pagesBest Practices, LLC © (919) 403-0251 1
  2. 2. Report Summary: Building an Effective Regulatory Relationship with the FDA This report delivers benchmarks and insights that identify effective interaction approaches for understanding and working with the FDA. Regulatory Affairs executives and managers can use this research to build better working relationships with the FDA by comparing their communication methods and policies with the practices of leading pharmaceutical companies. The research looks at how organizations can strengthen working relationships with the FDA by probing a number of key elements of their Regulatory Affairs office, including: • Organizational structure and alignment • Regulatory skill sets • Relationship management • Planning for critical FDA meetings • Understanding FDA cultureSTUDY METHODOLOGY This report is based on Best Practices, LLC research involving regulatory executives and managers from pharmaceutical companies and one medical device firm as well as information from the Food and Drug Administration and other agencies and industry associations. The research employed a two-pronged data gathering approach that gleaned quantitative data from a detailed survey and qualitative data from in-depth interviews with regulatory leaders at pharmaceutical companies and inside the industry to harvest insights and lessons learned on building an effective regulatory relationship with the FDA.SAMPLE FINDINGS Among the findings that emerged from this research are the following: • Organizational Structure and Location: 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. Most research respondents see an advantage to mirroring their own staff structure to that of the FDA in regard to those groups or functions that interact with the agency.Best Practices, LLC © (919) 403-0251 2
  3. 3. Report Summary: Building an Effective Regulatory Relationship with the FDA • The FDA and the Washington Ecosystem: 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. Avoid level-skipping to accelerate a decision. Level-skipping can cause longer-term resentment, distrust and harm to your NDA within the FDA. • Skill Sets & Capabilities: 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. • Planning and Preparation for the NDA: 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. • Safety and Risk Management: Consider hiring more safety experts to address new FDA safety priorities. Review Risk Evaluation and Mitigation Strategy section of Food and Drug Administration Amendments Act of 2007 and be prepared to talk about issues surrounding target populations and indications (labeling) earlier in the NDA process as a result of the legislation.Best Practices, LLC © (919) 403-0251 3
  4. 4. Report Summary: Building an Effective Regulatory Relationship with the FDADATA SECTION EXCERPTS Working with the FDA (an Excerpt) Survey responses and interviews with Regulatory Affairs executives with leading pharmaceutical companies revealed that relationship building through formal channels and on a personal level, is the No. 1 lesson for more successful FDA interactions. Top Methods for Working With the FDA Pharmaceutical companies noted that building strong formal relationships with the FDA and utilizing external communication techniques are Integral to the success of working with the FDA. Share your top three “lessons Learned” in forging productive FDA working relationships that help move your NDAs without unnecessary delays or surprises though the agencys review process. Formal Relationships Formal Relationships with FDA 26% with FDA Meeting External Communication with FDA 26% Informal Planning, Relationships Preparedness, with FDA Meeting Planning, Preparedness Field Lessons Productivity 24% and Productivity External Informal Relationships with FDA 21% Internal Communication Communication with FDA Internal Communication 3% % of Companies N=38 (13 companies provided 2-3 lessons learned) Copyright© Best Practices®, LLC BEST PRACTICES, ® LLC Figure 1: Top Methods for Working with the FDA The Role of Reputation (an Excerpt) Regulatory leaders for Top 10 companies spoke of the value of transparency in interactions with the agency and working as partners with the FDA during the review process. That approach was also championed by the former Deputy Commissioner who participated in this research. “Companies need to err on the side of being uniformly transparent,” the former deputy commissioner said. “Companies need to develop a reputation for good pharmacovigilance. IfBest Practices, LLC © (919) 403-0251 4
  5. 5. Report Summary: Building an Effective Regulatory Relationship with the FDA you have a good reputation, you can convince FDA on science, not political pressure. Most of the big pharmaceutical companies have these reputations that permeate the agency.” Many companies felt that Merck has the best reputation in the industry for guiding NDAs through the agency approval process. The former FDA Deputy Commissioner echoed that sentiment, saying the agency looks favorably on the company because of its science and pharmacovigilance programs. Pharmas Most Admired for FDA Navigation Skills In terms of moving NDAs through the regulatory process, Merck and Pfizer have the best reputations among benchmark partners. Rank your top 5 Pharmaceutical companies that you most admire for moving NDAs through the FDA regulatory process. Merck 45 Pfizer 32 GSK 29 Novartis 26 Eli Lilly 21 J&J 13 BMS 13 AstraZeneca 9 Wyeth 7 Roche 5 Sanofi-Aventis 2 Schering-Plough 2 Rating (Maximum Score=70) N=14 Copyright© Best Practices®, LLC BEST PRACTICES, ® LLC Figure 3.1: Pharmas most admired for FDA navigation skillsBest Practices, LLC © (919) 403-0251 5
  6. 6. Report Summary: Building an Effective Regulatory Relationship with the FDAREPORT STRUCTURE AND ORGANIZATION The research findings are organized into this executive summary with best practice chapters supported by survey data and charts. Executive summary: The executive summary contains a project overview, information about the participant companies and a summary of key findings. Best Practice Chapters: This section provides an analysis of the survey data along with detailed best practices uncovered in the participant interviews. • Chapter One: Structure and Rockville Satellite Office • Chapter Two: Building Effective Relationships • Chapter Three: Working with and Understanding the FDA and Washington Ecosystem • Chapter Four: Skills Capabilities and Competencies for Success • Chapter Five: Planning and Preparation for the NDA • Chapter Six: Safety and Risk ManagementABOUT BENCHMARKINGREPORTS.COM BenchmarkingReports.com is a service of Best Practices, LLC, world leader in benchmarking research and analysis. BenchmarkingReports.com provides vital insights and data from our primary research at a fraction of original project cost. Best Practices, LLC has conducted pioneering benchmarking research for top companies since 1991, providing clients with "Access and Intelligence for Achieving World-Class Excellence." To learn how we can help you find solutions to your current business issues, visit our site at www.best-in-class.com.Best Practices, LLC © (919) 403-0251 6
  7. 7. Report Summary: Building an Effective Regulatory Relationship with the FDATABLE OF CONTENTSExecutive Summary ....................................................................................................................... 6PROJECT BACKGROUND.............................................................................................................. 6RESEARCH METHODOLOGY........................................................................................................ 6KEY FINDINGS................................................................................................................................ 7THE BENCHMARK CLASS ........................................................................................................... 11REPORT STRUCTURE AND ORGANIZATION............................................................................ 11Structure and Rockville Satellite Office Overview.................................................................... 14ORGANIZATIONAL STRUCTURE ................................................................................................ 15CENTRALIZATION OF FUNCTION .............................................................................................. 17ROLE OF ROCKVILLE SATELLITE OFFICE................................................................................ 20Building Effective Relationships ................................................................................................ 26OVERVIEW.................................................................................................................................... 26FORMAL RELATIONSHIPS .......................................................................................................... 27INFORMAL RELATIONSHIPS....................................................................................................... 31EMAILS VS. PHONE CALLS......................................................................................................... 33ATTENDING CONFERENCES...................................................................................................... 34Working with and Understanding the FDA and Washington Ecosystem .............................. 37OVERVIEW.................................................................................................................................... 37WORKING ON RELATIONSHIPS ................................................................................................. 38THE ROLE OF REPUTATION....................................................................................................... 40THE WASHINGTON ECOSYSTEM .............................................................................................. 42Skills, Capabilities and Competencies for Success................................................................. 46OVERVIEW.................................................................................................................................... 46A DYNAMIC PROFESSION........................................................................................................... 47SKILL SETS ................................................................................................................................... 47Best Practices, LLC © (919) 403-0251 7
  8. 8. Report Summary: Building an Effective Regulatory Relationship with the FDASCIENCE VERSUS REGULATORY EXPERIENCE ..................................................................... 51FDA EXPERIENCE........................................................................................................................ 54PERFORMANCE MEASUREMENT .............................................................................................. 55Planning and Preparation for the NDA ...................................................................................... 58OVERVIEW.................................................................................................................................... 58STARTING WITH THE NDA.......................................................................................................... 59WHO SPEAKS, LEADS ................................................................................................................. 60MINUTES ....................................................................................................................................... 61WORKING WITH THE PROJECT MANAGER .............................................................................. 63PREPARING FOR NDA MEETINGS............................................................................................. 64MEETING REHEARSALS.............................................................................................................. 66NEGOTIATING FOR A WIN-WIN WITH LABELING ..................................................................... 70Safety and Risk Management ..................................................................................................... 70OVERVIEW.................................................................................................................................... 73REFOCUSING ON SAFETY.......................................................................................................... 74RISK EVALUATION AND MITIGATION STRATEGIES ................................................................ 77CHANGING SAFETY LANDSCAPE.............................................................................................. 78Best Practices, LLC © (919) 403-0251 8
  9. 9. Report Summary: Building an Effective Regulatory Relationship with the FDATABLES AND FIGURESFigure 1: Top Methods for Working with the FDA............................................................................ 7Figure 2: Best Practices LLC benchmark Class ............................................................................ 11Figure 1.1: Organizational oversight of FDA Function................................................................... 15Figure 1.2: Companies choose to mirror FDA structure ................................................................ 16Figure 1.3: Align your staff with their FDA peers ........................................................................... 17Figure 1.4: Organizational Structure for FDA Interactions............................................................. 18Figure 1.5: Regulatory oversees corporate FDA interactions........................................................ 19Figure 1.6: More utilization of Rockville office possible ................................................................. 21Figure 1.7: FDA focus Vital component of Rockville Offices ......................................................... 22Figure 1.8: More Emphasis places on FDA Liaison Role .............................................................. 22Figure 1.9: Key competencies needed in rockville ........................................................................ 24Figure 2.1: Engagement Strategy for FDA Staff ............................................................................ 27Figure 2.2: FDA Reviewers make Optimal partners ...................................................................... 28Figure 2.3: Emails and Phone best ways to contact FDA.............................................................. 33Figure 2.4: Email Used to build informal FDA relationships .......................................................... 34Figure 3.1: Pharmas most admired for FDA navigation skills........................................................ 41Figure 3.2: Biotechs Most Admired for FDA Navigation Skills....................................................... 42Figure 4.1: RA Profession - Integral to Healthcare Product Lifecycle ........................................... 47Figure 4.2: A matrix of characteristics can help in FDA work ........................................................ 48Figure 4.3: Regulatory Knowledge is most valued trait ................................................................. 49Figure 4.4: Legal/Regulatory background can help ....................................................................... 49Figure 4.5: Regulatory or clinical Backgrounds Preferred ............................................................. 50Figure 4.6: Balancing Backgrounds & skill sets............................................................................. 53Figure 4.7: Hiring the right kind of FDA staff.................................................................................. 54Figure 4.8: Companies have few staff with FDA experience ......................................................... 55Best Practices, LLC © (919) 403-0251 9
  10. 10. Report Summary: Building an Effective Regulatory Relationship with the FDAFigure 4.9: Regulatory uses Multiple Performances Metrics ......................................................... 56Figure 5.1: The high quality NDA support Safety .......................................................................... 59Figure 5.2: Gatekeeper Model Favored in FDA relationships........................................................ 63Figure 5.3: Key Roles During NDA Process .................................................................................. 65Figure 5.4: Companies divided about using outside expert........................................................... 66Figure 5.5: Many ways to help prepare NDA presentations .......................................................... 68Figure 5.6: Mock reviews core approaches for FDA prepration .................................................... 68Figure 5.7: The draft label sets the tone ........................................................................................ 71Figure 6.1: FDA continues to emphasize safety ............................................................................ 74Figure 6.2: Safety-Based Withdrawals........................................................................................... 75Best Practices, LLC © (919) 403-0251 10
  11. 11. Report Summary: Building an Effective Regulatory Relationship with the FDAORDER FORM I’d like to order the following Best Practice Benchmarking Report.® ID PUBLICATION TITLE QUANTITY PRICE SUBTOTALOP-104 Building an Effective Regulatory Relationship with the FDA Ordering 3 or more reports Deduct 10% Options Shipping and Handling: Add $26 ($48 international) per report ONLINE TOTAL benchmarkingreports.com PHONE SHIP TO: (919) 403-0251 Name Title FAX (919) 403-0144 Company EMAIL Street Address bestpractices@best-in- class.com City/State/Country Zip MAIL Phone Fax Best Practices, LLC 6350 Quadrangle Drive Email Suite 200 Chapel Hill, NC 27517 PAYMENT OPTIONS: Check enclosed payable to “Best Practices, LLC” Visa MasterCard American Express Card Number Exp. Date Authorized SignatureBest Practices, LLC © (919) 403-0251 11

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