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Tuesday, April 01, 2008

Making Friends for FDA

If you can’t find friends, create them: that appears to be the strategy at the embattled Food & Drug Administration.

FDA Commissioner Andrew von Eschenbach is clearly feeling more isolated in Washington and is in need of vocal supporters. Asked at a recent American Enterprise Institute meeting about the impact of celebrity survival stories on the advancement of oncology drug development, he noted wistfully that getting celebrity support was easier at his previous job running the National Cancer Institute.

“Celebrities, that was my former life,” von Eschenbach said. “At NCI, we had just wonderful people who would speak on behalf of the importance of the agency. We do not have that many celebrities speaking on behalf of the FDA. In fact, we do not have very many people at all speaking on behalf of us. If you would like to sign up, we’d sure like to have you.”

But he may have a solution to getting long-term support for the agency: he wants FDA to train its own cadre of supporters—to create its own empathetic and understanding constituency.

Von Eschenbach has begun featuring the establishment of an FDA-led, two-year fellowship program as one of his top initiatives before leaving the agency. He has highlighted the program in speeches to AEI and the Food & Drug Law Institute annual meeting (March 26).

The goal of the program is to train each year about 1,000 individuals near the starts of their careers in a credentialed program on the duties and skill sets necessary to support FDA decisions.

FDA would hope to be able to entice about 200 of each graduating group to stay on for careers within the agency. The other 800 would go out into academia and industry with a better understanding and empathy for FDA’s regulatory tasks. That group would represent a growing base of people who would be pre-trained to accept and understand FDA’s regulatory duties.

As the commissioner explains it, the people who get the fellowship training and go on to careers outside the agency will be the “sons and daughters of FDA, intimately knowledgeable of, and aware of, FDA policies and practices and also having an opportunity of communication and rapport with those within the agency.”

They will create a growing constituency for the agency that will help mitigate some of the sharp criticism of the agency’s regulatory activities. Von Eschenbach has been talking about the possibility of training a new cadre of FDA regulatory science specialists for over a year, but the recent discussions describe the programs as being beyond the conceptual stage and into the stage where FDA is talking with potential outside groups to take on parts of the training.

The fellowship program will be launched within the next six months, he told AEI. FDA has been talking with the Reagan-Udall Foundation about running the program. An FDA spokesperson says that the foundation is looking at the agency’s request that it take on management of the fellowship program.

The Reagan-Udall Foundation was chartered under the FDA Amendments Act, headed by former FDA Commissioner Mark McClellan and is the subject of funding controversy on Capitol Hill (see here). It is one of two high priority projects that the current FDA management is pushing in the waning days of authority that could establish long-lasting commitments by FDA to entities run by former commissioner McClellan. The other project is the Sentinel post-marketing surveillance system.

Von Eschenbach told FDLI that the foundation is actually further along on the project and has accepted the challenge to make the fellowship project work. “One specific initiative that the foundation has committed to, and agreed to take on as one of its first efforts,” von Eschenbach told the FDLI annual meeting, “is to support the creation and implementation of an FDA credentialed fellowship program.”

FDLI, which represents the food and drug bar, has also been in contact with FDA to partner on part of the fellowship training. Von Eschenbach said he would like to continue discussions with FDLI “about the important role that you could play in creating modules for the fellowship program” on regulatory law and policy.

Von Eschenbach sees the fellowship program as a key component of a strategy to address the daunting challenge of adding new staff (a goal of 700 hires this year) and replacing its aging workforce (30% of the existing workforce qualifies for retirement). Training an outside cadre of FDA experts can be dangerous. The agency’s advisory committees have in effect trained a number of academics in the nature of FDA decisions over the past thirty years and emboldened some to act outside the agency as surrogates for FDA. But with so few seemingly loyal allies and friends, it is easy to see why an FDA commissioner would find the appeal of training a new constituency for the agency.

1 comment:

Greg Simon said...

If we want to get new therapies to patients faster, the federal agency whose budget we should be doubling right now is not the NIH’s but the FDA’s. After years of an expanding mission and a shrinking budget, in 2007 the FDA was finally given new authorities and some new resources to try to keep up with the tide of new technologies, methodologies, and products aspiring to or already in the marketplace. The question is, will Congress and the agency itself follow through on the promise? The first step was not promising, as Congress withheld funding for the Reagan-Udall Foundation, newly created to support FDA’s important Critical Path initiative. Everyone who cares about cures needs to be watching.

Greg Simon
President, FasterCures