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.

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.