FDA Drug Lag: Challenges and Opportunities Working with FDA

CHI and Hogan Lovells convened a half-day program on the U.S. Food and Drug Administration (FDA) drug lag and the challenges and opportunities in working with the agency on new drug applications. Our guests heard from speakers including CHI’s CEO David Gollaher, Ph.D.; Rick Winningham, chief executive officer of Theravance Inc.; Marcea Lloyd, senior vice president, government and corporate affairs and general counsel at Amylin Pharmaceuticals; Beth Seidenberg, M.D., partner with Kleiner Perkins Caufield & Byers; Joseph T. Kennedy, vice president, general counsel and secretary for Transcept Pharmaceuticals, Shelley Chu, M.D., Ph.D. principal of Frazier Healthdcare; and Hogan Lovells partners Robert Church, Kevin Clayton, David Fox and Lynn Mehler.

Gollaher opened the proceedings in his keynote address, by providing highlights from CHI’s recent publication, Competitiveness and Regulation: The FDA and the Future of America’s Biomedical Industry. According to the report, which uses FDA’s own data to establish the relationship between regulation and the competitiveness of the industry, today’s FDA is not keeping pace with the innovation being produced here. The relationship between FDA and industry is strained by unexplained regulatory delays, a lack of clear standards for clinical data and an inconsistent and unpredictable pattern of communication, which has led to an increase in risk and a crisis in biomedical R&D funding. The resulting flight of product launches to EU countries should be cause for concern for everyone from policymakers to the patients who are most in need.

Subsequent speakers, including Lloyd and Winningham provided insights as executives from biomedical companies with products either currently in review at FDA or on the market, into the struggles these innovators are facing, with the capital markets in crisis and an uncertain regulatory process. Key takeaways from these people on the front lines included:

• This business is about patients. Period.
• Success depends upon taking, recognizing and managing risk.
• Surround yourself with smart advisors and even smarter employees.
• Precise communication is key – among all your trusted advisors and employees involved in the clinical trials, data analysis and regulatory approval of products, and regulators.
• It’s not just about strategy…perfect execution is key.
• Only the smart and persistent will survive in this climate.
• More companies will be forced to specialize and put all resources toward the most successful projects due to the higher barrier to entry.

Dr. Seidenberg, partner with Kleiner Perkins Caufield & Byers and Dr. Chu, principal with Frazier Healthcare, provided valuable insights from the venture capital perspective, explaining the consequences of increased risk, including money and people going overseas, not just to the EU, but to China. High tech and life sciences are both catalysts for growth overseas and Seidenberg noted that foreign executives are coming here to get educated and going back to their homelands to research, develop and commercialize medical technologies that have greater chance of being commercialized sooner overseas, rather than in the US. The regulatory and business environment in the US is “absolutely influencing our investing,” said Seidenberg, “we can’t sit back and let the US lose its competitive edge.”

When panelists, including Hogan Lovells experts from their global life sciences practice, Church, Clayton, Fox and Mehler, were asked what we can do to stem this tide of medical innovation leaving the U.S. in search of friendlier tax and regulatory environments, here were some of the insights shared:

• We need more dialogue between industry and regulators.
• We need clarification on the decision-making process, timelines and goals.
• We need more expert reviewers at FDA.
• We need to open the lens to assess risk and benefit in a systemic way.
• Without real, substantive change, the pain is going to go beyond investors and innovators – this is a crisis that is going to hurt everybody – most notably, the patients who need innovative, world-class therapies.

Stay tuned, as CHI and Hogan Lovells plan to release an Executive Summary on the proceedings from the meeting. For more information, please call CHI at (858) 551-6677.

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