Thursday, March 06, 2008

Vaccines: A Good News Story for FDA; Good for Goodman Too?

In the old days of Kremlin watching during the Cold War, analysts used to track who was standing next to Soviet bosses to get an idea of the sources of power and ideas.

There is a minor version of that game going on in the hierarchy at FDA as the agency prepares to find a new leader for its Center for Drug Evaluation and Research, the top manager in the regulatory group that controls the flow of new pharmaceuticals to the market--and, more and more, makes decisions on which products can remain on the market.

The job has been empty since last September. We have written about several of the likely candidates here. There appears to be an obvious incentive for the Bush Administration to try to get someone into that post before leaving office, to leave someone to take care of the remnants of the Bush FDA initiatives.

One hint of who might be rising in favor within FDA comes not from pictures of agency officials standing next to current Commissioner Andrew Von Eschenbach, but rather from what programs are getting the highest praise from FDA’s leadership.

From the rhetoric coming out of FDA now, the agency’s vaccine program is a good news story at a time when FDA is desperately looking for a way to show how it promotes the public health. As that program gets more attention, the star must be rising for the person in charge, Center for Biologics Evaluation and Research Jesse Goodman (pictured above).

Von Eschenbach gave what was billed to be a major address on the agency last Friday at the National Press Club in Washington, DC. That is the forum and audience that FDA commissioners in the past have used to speak forcefully to defend the agency in times of bad publicity.

We are not covering it until one week later. That says something about how stirring Von Eschenbach’s speech was on February 29.

Despite good intentions, Von Eschenbach appears destined to go down as one of most ineffectual public defenders of the agency in its history. Even during the bad days of the generic drug crisis in the late 1980’s, Frank Young was able to be more convincing about the agency’s ability to implement “Action Plans” to fix its processes.

To his credit, Von Eschenbach cannot be accused of over simplifying the challenges facing FDA or of relying on soundbites and glib reassurances. He is quite honest with the public that the agency continually faces a challenge of keeping up with advancing science and changing food, drug and device industries worldwide.

Von Eschenbach ended his NPC speech with the admonition: “All must understand that there never will be the end point—because the process of transformation, adaptation, and regeneration must be continuous and ever-evolving; that is the nature of the world in which we live.” True. It is just not the type of inspiring reassurance that the public wants about FDA now.

Still, the agency’s progressive and aggressive actions in the vaccine field drew the best rhetoric from the Press Club podium. Von Eschenbach mentioned the vaccine efforts nine times in a half-hour speech.

Here’s a sample of von Eschenbach’s praise for the agency’s role in bringing more manufacturers into the flu vaccine business in response to concerns about the next flu pandemic.

“Unlike three years ago, when we had only three licensed vaccine manufacturers of influenza vaccine licensed in the U.S., we now have six licensed firms. As a result, rather than a shortage that occurred a few years ago, this year we have excess capacity.”

And he noted that the agency has played a cooperative role with industry to get a H5N1 strain vaccine pre-approved. “In 2007, we licensed the first influenza vaccine against the H5N1 influenza virus.” He pointed to the step up in pandemic preparations as a sign that FDA can and “did change radically and rapidly with great benefit as a result.”

FDA would clearly like more tales of cooperation, with ample evidence of a clear benefit for society. If his rhetoric is a hint of where he thinks the agency’s success stories lie, look for Goodman to get more publicity and more responsibility.

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