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Is the New FDA Different than the Old FDA?

Two weeks ago, FDA Matters explored Dr. Hamburg’s legacy, focusing on advocacy for resources, prioritizing regulatory science and upgrading enforcement. These will be accomplished before she leaves office. But is she making similar progress in creating “a new FDA?”

Judging by her first year’s effort, FDA is becoming “new” in some important ways. Still, there are signs of retrograde attitudes and some ways in which FDA just doesn’t seem capable of changing.

Although FDA has long called itself a “public health agency,” it has been run by individuals who came from academic health centers. Dr. Hamburg and Dr. Sharfstein ran big city health departments. The agency’s decisionmaking standard has become “what’s best for the public health.” I think this is becoming a core part of “a new FDA.”

Dr. Hamburg has had new funds to work with, through both appropriations and user fees. Along with normal turnover, this means a substantial part of the agency workforce ten years from now will have been hired and trained during Dr. Hamburg’s tenure. All by itself, this contributes to “a new FDA” that will reflect her stamp.

Dr. Hamburg is trying to create “a new FDA culture,” a difficult task in any governmental agency. Thus far, it is defined by an intensity of activity and a broad range of initiatives. I see a new spirit within the agency: issues can be addressed if there is a public health impact, regardless of whether they would have been acted upon in the past.

The idea of “a new FDA” may be making less progress elsewhere at the agency. Traditionally, tougher enforcement has been cyclical. It will not become a constant force unless Dr. Hamburg chooses wisely for the new head of Office of Regulatory Affairs. The character of this person–FDA knowledge, superior leadership skills, new ideas about effectiveness and fairness, commitment to standards—will determine whether enforcement becomes a central part of “a new FDA.”

And then there are parts of FDA that still look a lot like “the old FDA.” Issue and activity silos are still the norm rather than the exception. Dr. Hamburg is setting a good example with her efforts to strengthen science agency-wide. But FDA cannot be considered “new” without substantial progress in making FDA and the American public the first loyalty of employees. It cannot be their branch, division or Center.

Despite sincere efforts by Drs. Hamburg and Sharfstein to clarify and expand upon agency positions and actions, public communications are still “old FDA.” The agency is struggling with so-called new media (Twitter, Facebook, blogs, etc), while attacking industry for recognizing and acting upon this new form of communications. FDA cannot be “new” (or even current) until it provides insight, guidance and “leadership by example” in this area. Efforts at improving transparency at FDA need to acknowledge that a broader range of senior leadership needs to be available to the press on a regular basis.

A “new FDA” cannot be achieved without the strongest possible commitment to innovation–in actions and not just words. Critical Path and advocacy for regulatory science don’t go far enough. Efforts to develop bio-markers and new statistical methodologies are worthwhile, but have the feel of “one-offs” instead of concerted efforts to systemically modernize the clinical trials system and the standards for FDA approvals.

Like her legacy, Dr. Hamburg’s effectiveness in creating “a new FDA” is still unwritten. It is too soon to know if she will succeed. She gets an A for having chosen far-reaching, worthy legacy items. The effort to create “a new FDA” must be considered a B- so far, showing good aptitude but still in need of better application and follow-through.

Steven

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It may seem premature to be discussing “the Hamburg legacy.” But you know that she is thinking about it (all commissioners do), so why can’t FDA Matters talk about it? Read the rest of this entry »

Fortuitous Timing and Public Health Leadership at FDA
March 14th, 2010

Commissioner Hamburg and Principal Deputy Commissioner Sharfstein are very good leaders who have also benefitted from their prior public health experiences and the timing of their appointments. Here is FDA Matters’ analysis: Read the rest of this entry »

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February 21st, 2010

With due respect to the many fine individuals that Commissioner Hamburg has recruited, FDA Matters thinks the most important appointment needs to be made soon: choosing the right person to be Associate Commissioner for Regulatory Affairs. Read the rest of this entry »

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