Thursday, April 17, 2008

Laying a Foundation for Success: Mark McClellan’s Vision for Reagan-Udall

If you want to build a new house, you start with a solid foundation. But if you want to build a solid foundation, where do you start?

For Mark McClellan, chairman of the Congressionally-chartered Reagan-Udall Foundation, that question turns out to be more difficult than anyone expected when the FDA Amendments Act—which chartered the foundation—was signed into law in September.

Reagan-Udall was supposed to begin operations with some seed funding from FDA, but concerns in Congress—primarily those of House Agriculture Appropriations Subcommittee chair Rose DeLauro—blocked that. So for now, the foundation has had to rely on 14 board members working on a pro bono basis to get up and running.

And the board has to accomplish two goals at the same time: crafting by-laws and processes to allow fundraising to begin, while working methodically to win over DeLauro and other concerned stakeholders to the broader mission of enhancing the scientific base governing the mission of the Food & Drug Administration.

“It will be a step-wise approach with getting the right bylaws, getting the right staff in place, having further opportunities for public input and discussion, and moving on to doing some broad based projects to improve the science for the FDA,” McClellan says. (For a complete transcript of our interview with McClellan, click here; a free registration is required.)

The first step in the process, finalizing the bylaws, should be complete in a matter of weeks, McClellan says. “Once our bylaws are in place and published, that is when we can start with the fund raising. There are a number of organizations and non-profit groups and the like that are interested in providing some of the core initial funding for the foundation. So that will be the next step and that means we will be able to have a staff in place and ongoing support for the product areas and initiatives.”

So it will still be a while before the foundation can actually get to work on supporting FDA’s scientific mission. There are at least three critically important areas where Reagan-Udall could play a prominent role in shaping the future of the agency and the pharmaceutical industry it regulates.

First, there is the directive for the foundation to shepherd and support FDA’s “Critical Path” Initiative, a program that has at least the potential to accelerate drug development. Second, the law also contemplates that the foundation will run a scientific fellowship program for FDA—a program FDA has already announced and is eager to get going.

Last but not least, the foundation is a good candidate to play a central role in the implementation of a new active surveillance system under development by FDA. That system could be the most revolutionary outcome of FDAAA, but its impact depends critically on scientific and procedural details that have yet to be worked out.

The foundation seems well on track to begin operations and start taking on those roles no matter what its Congressional critics think. However, the impact of the foundation’s work depends on winning over the concerned voices on the Hill. If the foundation ends up being painted as a vehicle for undue industry influence on FDA, any contributions it makes to the agency’s scientific underpinnings will become political hot-buttons.

McClellan, though, is optimistic that he can win over the skeptics. “We all share the same goal,” he says.

“There are a lot of good ideas from many members of Congress who all share the goal of improving the FDA’s ability to carry out its mission and improving the science available to promote the health of the public,” McClellan says. “Those perspectives are all going to get built into the further activities of the foundation.”

That’s why, in McClellan’s view, getting the process right on launching the Foundation is so critical.

“It is understandable that any kind of decisions involving FDA appropriations need to be made very carefully,” McClellan says. That is why there is “the need for transparency and clarity in the processes for the Foundation.” Concerned stakeholders must have “a good understanding of where funding would be coming from on the private side, and where it would be going,” McClellan says.

One example of how the foundation is working on its dual objectives: McCellan is relying on pro bono help from the DC law firm Zuckerman Spaeder to craft the bylaws. McClellan cited two former FDAers at the firm, Partner Bill Schultz and Counsel Peggy Dotzel, as providing the assistance.

In addition to the help they are providing on interpreting the Congressional directives for the charter of the foundation, Schultz and Dotzel’s involvement should offer some reassurance to skeptics in Congress. Both served in the Commissioner’s office under David Kessler during the Clinton Administration, and Schultz in particular established a reputation for independence from industry based on his prior experience with Public Citizen and with Representative Henry Waxman’s committee staff.

There is no doubt that the ramp-up of the foundation is going to take longer than its advocates wanted. But it seems clear that if there is any hope to build a strong Foundation to support FDA’s mission, the first step will be building a strong foundation of support from skeptics in Congress.

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