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.

Waiting for Sentinel: The Active Surveillance Revolution is Coming Soon

It sounds like the Food & Drug Administration is about ready to unveil its plans for a national active surveillance network, dubbed Sentinel. (Though hopefully that will be the only resemblence to the meanies in The Matrix.)

This long-discussed project was given a big push by the drug safety law enacted in 2007. The potential implications are truly revolutionary for biopharma companies—displacing the drug sponsor from its historic role as the center of the information flow about its own products.

The potential implications are one thing. The real implications will depend heavily on how the program is implemented—and by whom.

The new law directs FDA to set up a public-private partnership to help build an integrated national database of pharmacy claims, and develop the tools for analyzing signals to make regulatory decisions.

The law doesn’t say what role the pharmaceutical industry should or should not have in the system, how the agency should decide what signals to communicate publicly, or whether the claims data should be used for more than just safety assessments and made available to support other forms of research or even formulary decisions.

It is a safe bet that former Commissioner Mark McClellan will be involved; he championed the idea during the latter stages of the FDA legislative debate. In fact, the agency would really like to hand at least some of the project off to the newly formed Reagan-Udall Foundation chaired by McClellan but Congress has complicated that by prohibiting FDA from transferring funds to the Foundation.

The law does include some timelines and deliverables that mean the agency needs to get moving—something that regulators are eager to do anyway.

“Sentinel is a program you will be hearing about very soon,” FDA Commissioner Andrew von Eschenbach told the Food & Drug Law Institute annual meeting March 26.

How soon? Well, all we can say for sure is that it will be a month sooner than it was the last time we heard von Eschenbach discuss the idea, during an address to the National Press Club at the end of February.

But we do know a bit about where the agency is likely to be heading. Here are some “principles” that Associate Commissioner for Policy Jeff Shuren—who is the agency’s point person on Sentinel—outlined during Windhover’s FDA/CMS Summit in December. Shuren stressed that these are his personal thoughts.

(1) Scientific Credibility: Sentinel must win the “trust and confidence of patients, medical community, industry and other stakeholders.”

(2) Integrity: “The management structure and data analysis of this new system could be insulated from undue influence, whether by stakeholders or the political process.”

(3) Inclusiveness: “Stakeholders should have the opportunity to provide input into the standards and processes used by the system.”

(4) Transparency: “Protocols and study results should be made available to the public.”

(5) Privacy Protection and Data Security: This is “of paramount importance.”

Those principles seem hard to argue with.

Not everything is so simple, however. Shuren raised just a couple of the tough questions FDA and other stakeholders need to wrestle with.

For instance, there is the question of standards for interpreting safety signals in the Sentinel system. “When and with what level of confidence, can conclusions be drawn from the data?” Shuren asked.

“Even if we do not develop standards for such decision making—and it would be truly a challenging and controversial undertaking—we at least need to realize that there are likely different levels of confidence or certainty under which to make decisions regarding the treatment of a single patient versus formulary or coverage determinations versus decisions to change a product’s labeling," Shuren said. Which in turn raises the question: what access should FDA grant to the Sentinel data for other entities, like the Medicare agency or private payors, to support coverage decisions?

Those are the types of questions where most in industry would agree the right answer is worth waiting for.

An Ugly Divorce: Where Will David Kessler Land?

This was the email that went out to University of California San Francisco medical school staff on December 14 from Dean David Kessler:

Shortly after arriving at UCSF as Dean, I discovered a series of financial irregularities that predated my appointment. I reported these issues to appropriate university officials at the time, and have endeavored to work with the university ever since to solve these problems. The university characterized me as a whistleblower. During the summer, Chancellor Bishop requested my resignation. I continued to try to solve these problems. Yesterday, Chancellor Bishop terminated my appointment as Dean, effective immediately. Over the course of the past four years, it has been my pleasure and honor to work with the outstanding faculty, staff, students and donors of this remarkable school and institution. I want to thank all of you for the opportunity to foster and nurture outstanding programs on behalf of UCSF.

Sincerely,
David A. Kessler, M.D.
Professor of
Pediatrics, and Epidemiology and Biostatistics

The news came as somewhat of a shock to the academic community and Washington policy observers who followed Kessler when he was FDA commissioner under the Bush I and Clinton Administrations from 1990 to 1997. UCSF disputes Kessler’s account of the school’s finances.

It’s not the first time Kessler has stirred up controversy or been the target of an investigation into his handling of financial issues. Prior to his voluntary resignation as FDA commissioner in 1996, Rep. Joe Barton (R-Tex.) accused Kessler of overbilling the government for expenses of just under a $1,000. Kessler eventually wrote a check to FDA for the full amount.

After stepping down from FDA, Kessler subsequently took a position as Dean of Yale Medical School in 1997. After a six-year run at Yale, where it, in September 2003, Kessler was appointed Dean of the UCSF School of Medicine.

Kessler is not the first former FDA commissioner to have been involved in a dispute over the use of institutional funds. Former commissioner Donald Kennedy was forced to resign as president of Stanford University after 12 years (1980-1992) due to questions over the indirect use of university research funds.

Kessler says he will remain at UCSF as a professor but it’s hard to imagine that could last very long considering the nature of Kessler’s firing as dean. The RPM Report noted earlier this year that Kessler had reemerged from his quiet life as an academic and into the public spotlight as a very vocal observer in the wake of criticisms against FDA.

Kessler participated in a roundtable discussion of former FDA commissioners organized by the George Washington University School of Public Health in February. Kessler showed up a few months later at a May 7 House Oversight & Government Reform hearing on food safety.

At the time, we thought Kessler was angling for an appointment in a possible Democratic administration in 2008—maybe as head of NIH. But this latest spat with UCSF almost assuredly quashes any possibility of that happening. A new administration won’t be looking for a nomination fight early on in what looks to be another closely divided election.

But Kessler could still end up in Washington, nonetheless. His knowledge and skill in the area of health policy and regulation would be attractive to any number of think tanks inside the beltway. The Engelberg Center for Healthcare Reform was recently set up by former FDA commissioner and CMS administrator Mark McClellan at the Brookings Institute. Kessler also has ties to Ruth Katz, dean of the GW School of Public Health, and would be quite a catch for an institution taking an aggressive strategy in building up the school’s faculty.

However, it’s unlikely Kessler will find a position as prominent as dean of the UCSF medical school. And it’s all but certain that Kessler will be left out of the running for a coveted appointment if the Democrats take the White House.