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About FDA Matters

FDA Matters has grown steadily since I started it less than a year ago. My inaugural column was about the goals of the blog, but I have not written on the topic since or about my background and viewpoint.

I started the blog because of my frustration about how FDA was being described and analyzed during the period from Election Day to Dr. Hamburg’s confirmation. In particular, I spent a month telling colleagues: it is not true that there is going to be a power-sharing arrangement where Dr. Hamburg will concentrate on foods, while Dr. Sharfstein will concentrate on drugs and devices.

Even though I had no inside information, it was so clear to me…and yet many people thought otherwise and were impossible to persuade. I wished I had a platform to speak out, so I created one and launched it about 6 weeks later!

My goal is to write a blog that provides fresh insights and new perspectives for the broader community of people “involved in FDA matters and for whom FDA matters.” Hopefully, it is achieving that purpose by focusing on what the agency is thinking and how its actions are shaped by Congress, the media, stakeholders and external events. FDA Matters aspires to be a source of understanding about FDA, both directly and by stimulating dialogue.

Since FDA Matters began, one continuing theme has been the need to plan for FDA’s future. Another has been how the public health backgrounds of FDA’s leadership team make their thought process and actions quite different from any of their predecessors. Some themes I want to explore this year: re-inventing the clinical trial, the roll-out of the new regulatory pathway for follow-on biologics and improving regulatory science.

FDA Matters is not a voice for any interest group. The blog reflects my own analysis and commentary based on 35 years working in DC on health policy and legislative and regulatory issues. Earlier in my career, I was Health Staff Director and Counsel to the Senate Committee on Labor and Human Resources (now the HELP Committee). I had the great fortune to be one of the negotiators on the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) and on the Orphan Drug Act.

Subsequently, I was a Deputy Assistant Secretary for Health at HHS, responsible for policy development, planning and evaluation for the Public Health Service agencies. Since then, I have been a public affairs and regulatory consultant for a big firm, then started HPS Group, LLC in 2001 (www.hpsgroup.com).

One of my more recent accomplishments was helping to found the Alliance for a Stronger FDA (www.strengthenFDA.org). I serve (part-time) as the Deputy Executive Director of the organization. I believe strongly that FDA is dramatically underfunded and I write about this a lot. However, anything I write in FDA Matters is my own view and not that of the Alliance.

Over the years, my clients have included patient groups, health professions societies, research advocacy groups and individual companies. Many clients use me for legislative and regulatory analysis and to facilitate the development of policy and regulatory positions. Other clients use me for strategic regulatory counsel to help with development of medical products that are in phase II or phase III.

I welcome reader’s comments, either posted on the blog or by e-mail. I would be pleased if readers helped me initiate two features of the blog: point/counterpoint exchanges and “Ask Steven About FDA.”

Most of all: I believe that a better FDA is worth the effort to stay involved. I hope you see it that way, too.


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