FDA Commissioner Margaret Hamburg is getting a quick start on rebuilding the agency's public health credentials.

Hamburg's first public statement as commissioner of FDA came in the form of a perspective piece published in the New England Journal of Medicine. The article, co-authored by Deputy Commissioner Josh Sharfstein, lays out a vision for defining FDA's mission based on public health outcomes rather than regulatory actions.

The ¹ editorial is important on its face, offering the most detailed vision statement yet by the new leadership team about its goals for the agency. (At 1,800 words, the article is almost twice as long as Hamburg's written testimony during her Senate confirmation hearing.)

Published May 26, Hamburg's first day on the job at FDA, the NEJM piece serves as an introduction both to the medical community and the career FDA staff (see sidebar: " ² FDA's New Boss Introduces Herself "). She was sworn in May 22.

Just as important as what Hamburg says, however, is where she said it.

If the agency's mission is to re-establish its credibility as a public health leader, what better way than via an article in one of the most prestigious medical journals in the world?

The impact is all the greater because NEJM has been so tough on the agency over the past decade, frequently featuring editorials challenging specific agency decisions and decrying its overall culture.

And it was an article in NEJM - Cleveland Clinic Cardiologist Steve Nissen's review of the cardiovascular safety profile of GlaxoSmithKline's Avandia - that brought FDA to its lowest point in the context of public concerns about drug safety.

In that light, the implicit message of the editorial is a plea for breathing room, asking the thought leaders in medicine to hold their fire for a time while the agency gets back on its feet.

That context is critical for drug companies looking for signs of the regulatory climate they will face in the Hamburg era.

Given the venue, the article's even-handed discussion of balancing concerns about moving "too fast" on approvals with the dangers of being "too slow" to allow patient access to therapies should sound like a glass more than half full (see ³ Also see "Public Health Trumps User Fee Goals, FDA Leaders Say – But That May Be Good News For Sponsors" - Pink Sheet, 1 June, 2009.).

The message to FDA staff is equally important. For an agency that has learned to dread the perspective pieces in NEJM, the appearance of an article outlining the agency's commitment to a tradition of public health excellence by the new commissioner on her first day on the job powerfully demonstrates that the new leadership can do more than just talk about establishing credibility.

Both the editorial and Hamburg's e-mail to FDA staff show an adroit hand in finessing a potentially thorny issue: acknowledging and assuaging the agency's critics without alienating the career staff whose decisions have been criticized.

"In recent years, the agency has struggled to handle controversies involving the safety of regulated products, opening the door to legitimate questions from the media, the public and Congress about whether the public interest is being served," Hamburg and Sharfstein write.

"The public must trust the agency to base its decisions on science," they say.

They stop short, however, of agreeing that any specific agency decision was based on something other than science, and instead stress the need for a transparent process that "respects alternative viewpoints" and "defines and protects integrity."

In the all-hands e-mail, Hamburg declares the need for the agency to overcome "the perception that FDA has not performed well in recent years. Our goals must include restoring FDA's reputation and regaining the public's confidence."

- Michael McCaughan (m.mccaughan@elsevier.com)

The Hamburg Era Begins At FDA: NEJM Editorial Faces Critics Head-On, May Buy Breathing Room

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