The Long Campaign for FDA Commissioner (Part 3)

We’ve given you some of our thoughts on the candidates for FDA commissioner in the new Administration in several recent posts (here and here). Today, though, we tackle a bigger question: Why would anyone possibly want this job?

For a position that may well be the most thankless job in health care, an awful lot of people seem to be lining up to be the next commissioner of FDA.

With all the problems at FDA right now—a deeply underfunded agency with a nearly impossible mandate to protect the nation’s food and drug supply—it’s a wonder anyone would want to lead the agency. Add the prospect of contentious Senate confirmation hearings, a low public opinion of FDA, and a constant threat of whistleblowers, and you don’t exactly have your dream job.

But that hasn’t prevented people from wanting to be the next FDA commissioner. While much of the campaigning is taking place behind closed doors, some candidates are choosing to be a bit more vocal. Those individuals tend to fall into two categories; the Peter Rost Category of Candidates and the Steve Nissen/David Kessler Category of Candidates.

On one extreme end of the campaigning spectrum, there’s former Pharmacia marketing executive Peter Rost. As the Pfizer whistleblower over off-label promotion of the human growth hormone Genotropin, Rost is probably the one commissioner candidate that scares the bejesus out of pharma (or at least Pfizer) more than Nissen. Or he would if he had any chance of actually landing the job.

Not only is Rost openly campaigning, he is, in his words, “running” for FDA commissioner as though it’s an open Senate seat. Rost’s personal blog is now dedicated to his campaign run, and he has successfully solicited letters of endorsement from Sen. Sherrod Brown (D-Ohio) and Rep. JoAnn Emerson (R-Mo.).

On the other end of the spectrum, we’ll cite David Kessler. Kessler isn’t sending out press releases expressing his interest in the commissioner post, but he is indicating he’d be open to the job through public appearances. As we reported in an earlier blog post, when asked for his ideal profile for an FDA commissioner, Kessler essentially described himself.

The same goes for Nissen. While Nissen may be the last thing that anyone in industry wants in an FDA commissioner, he is laying out an agenda that sounds quite reasonable: more money for FDA, an end to the missed user fee deadlines, and restoring integrity to the agency. Indeed, we laid out in an earlier post why we think FDA commissioner Nissen wouldn't be the worst thing that ever happen to industry.

But even Nissen recognizes the challenges facing the next commissioner, and has publicly questioned whether anyone would want the job. Here’s what he said at FDC-Windhover’s FDA/CMS Summit last week:

“The problem is in the current environment, getting anybody confirmed looks like it could be really tough. You know what the last bunch of commissioners have gone through. You have to be a masochist to want to do that, and there aren’t a lot of people who would want to do that.”

Of course, in saying someone would have to be a masochist to want the job, Nissen didn’t mention whether he was a masochist. Knowing what we know about Nissen, we'd have to say yes.

image via run100miles.com. nothing particularly masochistic about that, eh?

FDA Commissioner Search: Finding Kessler’s Kessler

Former FDA commissioner David Kessler has the perfect person in mind to be the next head of the agency: (1) an MD (2) with a broad background in both foods and drugs (3) who is a Washington veteran and (4) has experience managing a 10,000-person organization.

Sound familiar? It should, since that is essentially Kessler’s curriculum vitae.

Kessler received his medical degree from Harvard. As FDA commissioner under the Bush I and Clinton Administrations, he took on Big Pharma and Big Food—as well as Big Tobacco. As a former head of FDA, he is a familiar face inside the Beltway and has obvious experience managing a government agency.

We’ve speculated that Kessler could make a return visit to the FDA commissioner’s office, and we’ve also observed that after many spending many relatively quiet years as an academic—first at Yale Medical School, and then at the University of California-San Francisco—he’s been pretty outspoken recently about what’s wrong with FDA.

But is he interested in the job? As reported in this week’s issue of “The Pink Sheet”, the answer to that question appears to be no—but not enough of a no to shake the suspicion that it might really be yes. When asked if he’d be interested in taking over FDA for the Obama Administration, Kessler shook his head no. “That was an historic period,” he said. “I don’t know how we’d do it again.”

OK, so we’re not taking him off our lists quite yet. But if it isn’t Kessler himself, then who is Kessler’s Kessler? Here’s a snapshot of his picks and pans for the job, as conveyed during a recent event hosted by the public relations firm Fleishman Hillard:

Mike Taylor: “My deputy in policy [at FDA]; went to run [the Food Safety and Inspection Service]; probably the best food safety person in the country but not a doc. You may have to go for the first time with a non-doc.” [One of our observant readers pointed out that there is precedent for at least one non-MD who served as commissioner in the modern era: Jere Goyan. He was a PhD pharmacist.]

Bill Schultz (Zuckerman Spaeder): “Probably as knowledgeable as anyone on FDA. Real pro, but again not a doc.”

Josh Sharfstein (Baltimore City health commissioner): “On Waxman’s staff; worked for me; Baltimore public health commissioner; hasn’t run anything quite as big as FDA.”

Steve Nissen (Cleveland Clinic cardiologist): “What does he know about foods? What does he know about running Washington? Has he been there before?”

Of course, we’re still a long way from hearing anything definitive about the FDA commissioner—president-elect Obama’s formal announcement of Tom Daschle as HHS secretary is still pending, after all. Until then, we’ll keep on speculating.

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.

The Return of Lord Kesslermort

Where am I going with this, you ask? Well, he's been in hiding for years and all of a sudden there are ominous signs of him everywhere. While he doesn't literally carry the Dark Mark, he may as well from the drug industry's perspective (note: if you are not getting these Harry Potter references, my apologies, but I just finished the last book.)

I'm talking about former FDA Commissioner David Kessler, who served as head of the agency from 1990, under Bush I, to 1997, when he was succeded by Jane Henney in the twilight years of the Clinton I Administration. Kessler is arguably the most controversial commissioner in recent times for the way he took on drug companies, Big Tobacco and even orange juice producers. His pursuit of having FDA regulate tobacco products resulted in the FDA vs. Brown & Williamson Tobacco Co. case, which the agency lost.

In 1996, with the voices opposing him growing louder and louder, Kessler announced he was stepping down, and subsequently took a position as Dean of Yale Medical School in 1997. In September 2003, Kessler was appointed Dean of the University of California, San Francisco School of Medicine. Now 56, Kessler has reemerged from his quiet life as an academic and has been very vocal in the wake of criticisms against the FDA.

Kessler participated in a roundtable discussion of former FDA commissioners organized by the George Washington University School of Public Health on February 21st. Here's a few things he had to say:

On PDUFA:"We are willing to continue to support PDUFA...But if PDUFA is a negotiation with the regulated industry, I don't think that is going to be trusted," Kessler said at the GW panel discussion.

On FDA leadership stability: "You can’t have a commissioner every 18 months. You can’t run an agency if a commissioner is there for such a short period of time."

On personalized medicine: "The model that pharmaceutical development is based on is not a sustainable model. The notion that there are going to be drugs that we are going to be able to come up with and have millions and millions of people take safely—the blockbuster—that is the thing that has gotten us in this trouble."

After the GW panel, Kessler showed up a few months later at a May 7 House Oversight & Government Reform hearing on food safety. "Simply put, our food safety system is broken," Kessler testified at the hearing.

This quote, however, is what really grabbed my attention. In a great article by one of my favorite writers, Geeta Anand in the Wall Street Journal, Kessler says it's time to get novel, potentially life-saving therapies to market even faster than is currently being done. "We have to find creative ways of getting cancer drugs to patients even if we end up being wrong a few times,"Kessler said in the piece. Anand highlights the birth of the accelerated approval process under Kessler's watch. And despite his "anti-industry" reputation, he's the one that made the user-fee system work.

This seems to be an attempt by Kessler to remind the drug industry, "Hey, I'm for accelerating drug approvals." In my humble opinion, it appears that Kessler's recent high profile means he's angling for something, but what? When it comes to the FDA, it's a case of "been there, done that" for Kessler. CMS Administrator? I don't think so. In his stints at Yale and UCSF, he's worked jointly with their respective hospitals and health systems and he has an Advanced Professional Certificate in Management from New York University Graduate School of Business. But I don't think that's his cup of tea. It's more difficult to have a broad brush-stroke impact on healthcare at CMS compared to other agencies in the government.

That leaves two positions: director of the National Institutes of Health with its enormous budget or Secretary for Health & Human Services. I think Kessler would be a perfect fit for the former in a Democratic administration. He's an academic at heart and has led very large academic research institutions/budgets. But I think he wants the latter, where he could lead the public health agenda and finish off his crusade against tobacco which he started over a decade ago.

He's got ties to the Clintons, should Hillary Clinton win the election. However, she may want to distance herself from such a lightning rod as she seeks to stay in the political center. Kessler also has ties to Illinois, receiving his law degree from the University of Chicago in 1978. I'm not sure how much that would help him if Barack Obama were elected President. If a Republican takes the White House for a third consecutive term, I think it's back to the quiet of academia for Kessler.

Nevertheless, drug industry watchers should stay vigilant for anymore signs that He-Who-Must-Not-Be-Named will return.