Is it Worth It?

The term that keeps coming up when you talk to Republican staffers in the House of Representatives about their 2011 agenda is: oversight.

“I think one of the lessons Republicans learned when they lost power in 2006 is they should have done more oversight of their own people,” says one Democrat on Capitol Hill who doesn’t think oversight of the Obama Administration would be such a bad idea.

If Republicans didn’t learn the lesson of conducting more oversight of their own, they sure are planning to teach a lesson to their colleagues on the other side of the aisle.

Unless you were living under a rock, you know that repealing health care reform was one of the top issues Republican candidates across the country ran on as they took over the majority in House and made major gains in the Senate.

The start of that process, according to many Republicans, is to haul up heads of key agencies in HHS—including the HHS Secretary Kathleen Sebelius—to start asking some hard questions about healthcare reform and its implementation going forward.
“Once he gets vaccinated, we look forward to seeing him” for oversight hearings, quips one Hill staffer of Acting CMS Administrator Don Berwick, who has yet to go before a House congressional committee but will testify before the Senate Finance Committee on November 17.

CMS is already a focal point of the soon-to-be incoming Congress with pending national coverage decisions for Dendreon’s prostate cancer cell-based immunotherapy Provenge, Amgen’s Aranesp and erythropoiesis-stimulating agents (ESAs), and the possibility of doing the same with Roche/Genentech’s Avastin for first-line treatment of breast cancer.

The House Oversight & Government Reform Committee, which will be chaired by Rep. Darrell Issa (R-Calif.) come January, has already sent a letter to FDA Commissioner Margaret Hamburg probing the agency’s oversight of pharmaceutical manufacturing plants in Puerto Rico. The letter promises more questions in the future, and we expect an in-person appearance before the committee will not be far off.
The question is: are Obama Administration officials ready and willing to face a hostile Congress for the two years?

There are already rumors in Washington that HHS Secretary Sebelius could be the next high-level official out the door. And FDA Commissioner Hamburg has a built-in successor in Deputy Joshua Sharfstein, who has previous Hill experience. And remember, Berwick is still only “acting” (he was a recess appointment) and has yet to be confirmed by the Senate.

Whether they stay or go may depend on their appetite for a good, long public fight. Do they think it’s worth it? We’ll know in the next 12 months.

While You Were Eating Beignets...

It's the first weekend in December and that means it's time once again for the American Society of Hematology meeting. This year, reps from biotech and pharma travel to N'awlins to make news--or at least issue press releases--before the last year of the first decade of the 21st century comes to a close.

And for the foodies/cultural mavens in the industry, how can you blame them? Where else can you indulge in chicory coffee, beignets (essentially fried dough, but the French makes it sounds waaaay better), and gumbo, while also soaking up the music scene?

If you weren't at ASH, you were likely debating the merits of football's popularity contest, aka the Bowl Championship Series, or Tim Tebow's oscar-winning performance after the Gators lost to Alabama. Or maybe you were engaged in that annual ritual now closely tied with propping up the national economy...filling recycled, reusable bags with unnecessary plastic items manufactured in China.

Away from food, footballs and rituals: this week's dealmaking got off to a healthy start, with Celgene announcing it was buying private firm Gloucester Pharmaceuticals for $340 million in cash, plus up to $300 million in future US and international regulatory milestones. The deal further strengthens Celgene's cancer franchise--more specifically, its blood cancer franchise--as Gloucester's romidepsin (Istodax), a histone deacetylase inhibitor, was approved by FDA in November for cutaneous T-cell lymphoma.

Not that Celgene's early Monday morning shopping should overshadow our hand-picked selection of the weekend events that happened while you were searching in vain for a $10 Zhu Zhu hamster... (Fuhgedabout it!)

New Yorker's Atul Gawande analyzes the current health care reform bill under review in the Senate. The fact that there is no grand master plan for curbing costs is actually a good thing, he argues. (If you haven't read Gawande's latest, you should. He's required reading in the West Wing.)

The WSJ reports Obama went to the Hill to urge the Dems to stay united as the Senate debated a proposed compromise option to the public plan. Meanwhile NYT's Prescriptions Health Blog outlines the advantages of a hybrid plan, the Federal Employees Health benefits Program.

There's lots for Sharfstein and Hamburg, the FDA's dynamic duo, to keep an eye on as they promote their safety first agenda. This weekend news surfaced that a Fresno, CA-based company recalled 22,723 ounds of ground beef potentially linked to salmonellosis; and then there was the NYT article on the safety of plasma products.

Also in the NYT this weekend, a story on the outsized pricing of cancer med Folotyn. The article is sure to spark renewed debate from payers about reimbursement for high priced meds that add just a few months of life. That's bad news for pharmas looking to cash-in on this specialty market.

ASH-related headlines: Cell Therapeutic's pixantrone increases median survival by 3.3 months in patients with relapsed/refractory NHL; Onyx/Proteolix presented updated Phase IIb data from studies of their next-generation proteosome inhibitor, carflizomib; privately-held Gloucester Pharmaceuticals presents additional data on newly approved ISTODAX in cutaneous T-cell lymphoma.

It wasn't just cancer at ASH; new data about next-generation blood thinners from Johnson & Johnson and Boehringer Ingelheim were reported at the meeting in conjunction with an article in the NEJM.

(Image by flickrer and[w] used with permission through a creative commons license.)

Following Up With Sid Wolfe (Part 2)

Washington is full of interesting connections.

Given how much people jump from job to job in DC, it’s only a bit of an overstatement to say that everybody has worked with everybody at some point in their careers.

So it should come as no surprise, perhaps, that Joshua Sharfstein, the incoming principal deputy commissioner of the Food & Drug Administration, used to work with a prominent policy figure in Washington who happens to be a staunch critic of the pharmaceutical industry.

No, we’re not talking about Rep. Henry Waxman, for whom Sharfstein worked early in his career. This is someone perhaps even less favorable to Big Pharma (if that could be possible): Public Citizen’s Health Research Group director Sidney Wolfe.

Sharfstein worked at Public Citizen as a researcher between April-August 1992—after completing his undergraduate degree from Harvard University and starting medical school. During his five months at Public Citizen, he contributed to a report on the capacity of the U.S. correction system’s ability to care for mentally ill. (One finding: states without adequate inpatient mental health facilities jailed mentally ill patients rather than providing appropriate treatment.)

In an interview, Wolfe recalled Sharfstein's stint at Public Citizen, but was careful not to give him too much praise. When asked of his impressions of the incoming FDA official, Wolfe spoke generally of the “extreme public health experience” of both Sharfstein and FDA commissioner-designate Margaret Hamburg. “I can’t remember the last commissioner with solid public health experience,” Wolfe said. (He discounted David Kessler, who as the former head of a hospital, Wolfe says, did not rise to the same level as health commissioner of a big city.)

After Public Citizen, Sharfstein went into his first year of medical school, and promptly did something rather Wolfeish: he led a student campaign urging his classmates to return free textbooks donated by pharmaceutical companies.

According to a story in the Harvard Crimson, Sharfstein set up a drop-box for students to return two textbooks donated by Sandoz, and wrote a letter to president Timothy Rothwell protesting their distribution. The protest didn’t seem to attract much support: few books were returned, and a few that were returned were stolen from the drop-box.

Wolfe and Sharfstein kept in touch, collaborating on a 1999 petition to then-HHS secretary Donna Shalala against Pfizer’s marketing practices for the antibiotic Zithromax. Wolfe and Sharfstein, who at the time was a pediatrics fellow at Boston Medical Center, accused Pfizer of launching a campaign to convince physicians to prescribe Zithromax over the “effective and inexpensive” antibiotic amoxicillin—against CDC guidelines.

They also testified at the same FDA public hearing in 2008 over the safety of cough and cold medicines; Sharfstein petitioned FDA to relabel the products as not safe and effective for children under six years. At the public meeting, Sharfstein was the opening presenter, and Wolfe spoke during the open public hearing portion of the meeting.

We're not saying that makes them bosom buddies, but it does make for an interesting Washington connection.

FDA Commish To Employees: Keep Quiet or Else!

Frank Torti, the acting FDA commissioner, has an important message for all agency employees--you won't make a peep if you know what's good for you.

In an unusual memo distributed last Friday afternoon, Torti ensured the agency is committed to transparency and “the principles of open government.” But after dispensing with the obligatory qualifier, he then went on to warn FDA employees the agency “must comply with its obligations to keep certain information in its possession confidential.”

He then writes those obligations are spelled out in the Food, Drug, and Cosmetic Act, the Freedom of Information Act (FOIA), the Trade Secrets Act, and the Privacy Act, as well as FDA regulations. But if agency employees violate these provisions, they may face disciplinary sanctions, criminal liability and the FDA could be sued for damages.

Torti cites five sweeping categories of info that must be kept under wraps: trade secrets; confidential commercial info; personal privacy data; law enforcement records and privileged intra-agency and inter-agency documents, such as emails, memos and letters between between FDA employees. This last category can be a veritable treasure trove, however, because it can include opinions issued by FDA employees and materials prepared in connection with litigation – the sort of stuff that makes a good headline.

The missive, which an FDA spokeswoman tells us speaks for itself, may have its roots in a recent pair of embarrassing episodes that stemmed from the discussion or release of what FDA officials may view as privileged info. Earlier this year, nine FDA scientists wrote President Obama’s transition team that the review process for medical devices was ‘corrupted and distorted by agency managers.’

An example surfaced last week in a report in The Wall Street Journal, which detailed how a lobbying campaign overcame internal dissent among FDA staffers, who objected to the approval of a ReGen Biologics device for knee injuries. Former FDA commish Andy von Eschenbach acknowledged the affair was handled poorly.

And last month, the FDA removed Sanjay Kaul, a well-known cardiologist at the Cedars-Sinai Heart Institute in Los Angeles, from a meeting of its Cardiovascular-Renal Drugs Advisory Committee at the last minute over the potential for intellectual bias.

The move caused an uproar after it became known that officials at Lilly, whose prasugrel blood thinner was to be reviewed, called FDA offices prior to the meeting to complain about Kaul, who had been openly critical of the drug. The FDA's head of the Office of New Drugs, John Jenkins, later admitted the "disinvitation" was a mistake.

It's unclear whether the memo is directly related to either of those incidents, or if it was issued for more general reasons, although a good source suggests the recent flaps likely had a lot to do with it, because such memos are rare. In any event, one thing is clear: we managed to get a copy, so it doesn't seem to have struck too much fear in the hearts of FDAers. The irony of it all.

Galson’s Next Career Move: Tobacco Chief?

For former FDA official Steve Galson, the news that CNN medical correspondent Sanjay Gupta has withdrawn from consideration as President Obama’s top choice for Surgeon General means that he still has a job—at least for a little while longer.

Galson, the former director of FDA’s Center for Drug Evaluation & Research, has served as acting Surgeon General since October 2007. Since then, he has kept a relatively low profile, even for his office, which hasn’t had a publicly visible Surgeon General since C. Everett Koop during the Reagan Administration.

Gupta’s star power would have changed all that, but it looks like that’s not in the cards. For Galson, that means holding down the fort a little longer while Team Obama regroups and settles on a backup. When this does all shake out, Galson will have a lot of options—a return to FDA among them—as we’ve blogged in this earlier post.

So we’d like to put forth a suggestion made by one of our intrepid readers: should Congress agree to give FDA regulatory authority over the tobacco industry, who better to head the Center for Tobacco Products than former acting Surgeon General Steven Galson?*

Here’s why: Galson is a former FDA official, so he’s walked that beat before. He is a rear admiral in the Public Health Service, so he’s got that angle covered. He’s worked for the Centers for Disease Control & Prevention, so he knows all about the risks associated with tobacco use. And he’s been at the Environmental Protection Agency—hey, isn’t tobacco an environmental hazard?

We think it’s a brilliant fit, and the timing might work out perfectly. Once a permanent Surgeon General is named, Galson isn’t likely to stick around. While he has said he’d consider a return to FDA, that depends in large part on the inclinations of the expected commissioner nominee, Margaret Hamburg. (Which, despite what you may have read elsewhere, you heard about here first. Just saying.)

Anyway, given that congressional action on tobacco is a foregone conclusion, the Administration will be looking for someone to head up FDA’s oversight. Hamburg may choose to take an active role, given her resume, but she’ll still need someone to head the center. We figure that at about that time, Galson will be looking to make his next career move. What perfect timing!

Naturally, there are a lot of “ifs” in that scenario: if FDA gains the authority to regulate tobacco; if the law clears the legal challenges that are sure to follow; if Galson is offered the job; and if he is willing to accept it. (And if the world hasn’t ended by the time all that happens.)

Given all that, it may not happen. But it sure is fun to think about.

*Not based on fact or rumor; just a career suggestion.

FDA Commissioner Hamburg

As we've reported to you before, the White House is closing in on naming former New York City Health Commissioner Margaret Hamburg as FDA Commissioner. 

Hamburg is understood to be currently preparing for Senate confirmation hearings. Baltimore Health Commissioner Joshua Sharfstein will reportedly serve as principal deputy commissioner.

To read the full story, click here at The RPM Report.  The announcement could come Monday. 

Von Eschenbach Maps Out Role In Health Reform

“I’m not going to go fishing and play golf.”

That is how former FDA commissioner Andrew von Eschenbach describes his post-government plans after leaving the Food & Drug Administration: a consulting gig at Greenleaf Health LLC, a return to MD Anderson and any “other opportunities,” should they present themselves. Von Eschenbach left FDA in January when President Barack Obama took office and has kept mum about his future plans.

Until now. On the policy side, von Eschenbach is teaming up with an old FDA colleague—his former chief of staff Patrick Ronan. Von Eschenbach will be a senior adviser at Greenleaf Health, a regulatory consulting firm that Ronan founded upon leaving FDA in 2006. Ronan was von Eschenbach’s chief of staff for his first year on the job, and the two have kept in touch after Ronan left the agency, von Eschenbach said.

Greenleaf’s clients include medical device companies, pharmaceutical manufacturers and public relations firms, but Ronan says Greenleaf’s sweet spot is with smaller biotechs without a Washington presence that need regulatory guidance. Ronan and von Eschenbach are the two principle advisors; Greenleaf also has a chief marketing officer.

Of course, as a former government official, von Eschenbach is restricted in the work he can do as an industry consultant. For the next year, for example, he cannot advocate directly to FDA on behalf of a third party. And he has a lifetime ban on lobbying the agency on the rules and regulations upon which he worked on or influenced while he was commissioner.

But in speaking to von Eschenbach, that doesn’t sound like the type of work he’s interested in anyway. In a phone interview, von Eschenbach talked broadly about “contributing to a more strategic discussion of the future of health care” and helping to find “integrated solutions” for diseases like cancer and Alzheimer’s—all in the context of the greater health reform debate.

As he was at FDA, von Eschenbach is interested in issues like personalized medicine, genomics and informatics, and ways in which the system can prepare for a more patient-centric health care environment. Greenleaf, he says, is a great “launching pad” by which to contribute to those kinds of macro health care issues, and participate in a “greater conversation on a global perspective.”

Von Eschenbach is also “deeply interested” in directly contributing to health reform efforts—one of President Obama's priority issues for his first term. Von Eschenbach says he is open to talking to policymakers (without directly lobbying anyone) about changes that are needed to support the types of products—like personalized medicine and drug-diagnostic combinations—that he believes will be the future of health care. (Von Eshenbach offered thoughts on that topic during a recent health policy conference sponsored by The Atlantic. You can read more in an upcoming issue of The RPM Report.)

If that weren't enough, he's also returning to academia. As we predicted in an earlier blog post, Von Eschenbach is returning to University of Texas MD Anderson Cancer Center in Houston, where he spent 25 years of his career in various leadership positions before being named director of the National Cancer Institute in 2000.

Upon his return to MD Anderson—which is still in the works—he will be an adjunct professor and will serve on the advisory board of the David Koch Center for Applied Research in Genitourinary Cancers. His first board meeting is April 3.

FDA Commissioner Update: Announcement Timing Provides Clues

Comments out of the White House that an announcement is imminent on President Obama’s choice for FDA commissioner indicate the pick is someone who has already been thoroughly vetted.

Duke cardiologist Robert Califf and Baltimore Health Commissioner Joshua Sharfstein have been formally interviewed for the job by HHS Secretary-designate Tom Daschle and would appear to be the two most serious names to make the final cut (“The Pink Sheet,” January 19, 2009, p. 3).

It’s understood that Califf has the backing of Senate Health, Education, Labor & Pensions Committee Chairman Ted Kennedy (D-Mass.) while Sharfstein is being vigorously supported by House Energy & Commerce Committee Chairman Henry Waxman (D-Calif.).

“I know the President hopes in the next few days to announce a pick for commissioner at FDA,” Press Secretary Robert Gibbs said during a briefing on January 30 in response to a question regarding tainted peanut butter. To read the thoughts of our OTC friends on an agency review, click here. (For peanut-butter-jelly-time, click here.)

The timing of the announcement makes it less likely that a name to have emerged recently would be under serious consideration for the FDA post unless the individual had already been through an interview with either Daschle or White House personnel officials.

For example, former New York City health commissioner Margaret Hamburg’s name made the rounds of the Washington rumor mill over the last week. While Hamburg was a member of the HHS transition team, is a former high ranking HHS official, and could be considered for any number of health positions, it’s unclear whether she received anything more than a screening interview. To read more about Hamburg, click here.

Former FDA commissioner Jane Henney could be a strong fallback option if the administration feels Sharfstein and Califf don’t meet all of the necessary criteria for the job. Whether Henney ever went beyond the initial screening process, however, is unconfirmed.

Still, the FDA announcement could wait until the tax situation holding up Daschle’s confirmation becomes more lucid and predictable. President Obama told White House reporters he “absolutely” stands behind Daschle’s nomination for HHS Secretary.

In fact, the administration is proceeding as if the confirmation will be a forgone conclusion. Obama’s top FDA advisor in the Senate Dora Hughes is now at the White House working with the health policy group, presumably in the Office of Health Reform. Harvard economist and top Obama advisor during the campaign David Cutler is also moving to Washington to work on the administration’s reform agenda. To read more, click here.

NIH Department of Bioethics Chairman Ezekiel Emanuel is on detail to the Office of Management & Budget working with new health desk head Keith Fontenot on health reform issues. To read more about Fontenot, click here.

Emanuel, author of the health care book “Healthcare Guaranteed,” is the brother of White House Chief of Staff Rahm Emanuel.

Sharfstein Speaks: Is He Headed To Washington?

During a Baltimore City rally for Barack Obama on Saturday, Dan Rodricks, a host for the local National Public Radio station, WYPR, got a coveted interview with a Baltimore official who has been making national headlines.

No, it wasn’t Baltimore City mayor, Sheila Dixon, who was recently indicted for perjury and theft charges (and who, may we add, did not receive a shout-out from president-elect Obama when he addressed the massive crowd).

WYPR spoke to Baltimore City health commissioner Joshua Sharfstein, one of two finalists for the FDA commissioner job. (You can read all about that story in this week’s issue of “The Pink Sheet.”) Sharfstein was at the Obama rally in an official capacity as health commissioner, directing people to warming tents and trying to prevent hypothermia and frostbite.

And while that's certainly a good story, Rodricks also asked Sharfstein whether he would leaving Baltimore to become FDA commissioner. Sharfstein was non-committal (as would be expected), but also expressed his deep admiration for Obama, and the science-based policies that he will support as president.

We’ll let you be the judge on the meaning behind his remarks. Here’s the interview, as transcribed by us from an online recording of Dan’s show, which aired yesterday afternoon:

Dan Rodricks: Are you going to go to work in Washington? Are we going to lose you here in Baltimore?

Joshua Sharfstein: I’m fully expecting to be health commissioner of Baltimore. It’s a great job, and lots to do this year.

Rodricks: OK, because there have been all these stories in the press about Joshua Sharfstein and the Food and Drug Administration.

Sharfstein: I know, my mom sends them all to me.

Rodricks: But you’re going to be around here for a while?

Sharfstein: That’s what I totally expect.

Rodricks: What do you expect from Barack Obama….Are you expecting generally more progressive ideas coming out of the White House?

Sharfstein: Absolutely. The first thing he said is that he wants to base health policy on the science. That’s a huge shift from what we’ve had. When you look at the science, you look at what things have worked, those are the kinds of things that we’re trying to do in Baltimore. I think we can expect some support for that, because we’ve got evidence for what we are doing. ...

Rodricks: Have you felt this way before about a president?

Sharfstein: I’ve never experienced anything like this. It’s been terrific. I’ve had a chance to work on the transition some, and that’s been great. From the moment—I just remember Iowa and everything, it’s just been so exciting.

Photo credit: Reuters/Jason Reed

FDA Commissioner Update: Califf's Name Emerges But Is Sharfstein the Pick?

We know you've been waiting on the edge of your seat so we thought we'd send you an update. We've heard that Duke researcher Robert Califf and Baltimore Commissioner of Health Joshua Sharfstein have been tapped, at the very least, for interviews. 

In fact, multiple sources say Sharfstein may have been offered the job. But we're not quite ready to confirm that just yet. 

Califf as we understand it has the support of senior FDA officials who would be very happy if he were named FDA Commissioner. Califf knows the folks at the agency quite well. In September 2006, Duke entered into an agreement with FDA to serve as a warehouse for electrocardiograms to serve as tools for drug safety research through the Critical Path Initiative. In addition, he's served on FDA advisory committees. 

As we've said before (click here), if the Administration chose to go with a big name who was less controversial, Califf would fit that description. His ties to the drug industry would be a hindrance in the vetting process, but as we understand it, Duke has among the strictest, most transparent guidelines when it comes to running their clinical trials for drug developers. 

The choice of Sharfstein would indicate the transition knew exactly who they wanted to head the agency from the beginning. Sharfstein is leading the FDA review team for the HHS transition. We'd heard Sharfstein had encountered resistance from different stakeholder factions but clearly he's been able to overcome those concerns. 

To read the likely picks for FDA Chief Counsel and HHS General Counsel, see our previous post here. We'll let you know as soon as we find out more. 

FDA Commissioner Update

It looks as if the Race to White Oak is almost over. We know at least one commissioner candidate was informed of the decision yesterday.

As we said previously, a decision was likely to be made yesterday with an announcement coming later this week or soon thereafter. To read our previous post, click here.

We also understand that David Dorsey could be named FDA Chief Counsel and Bill Schultz could be named HHS General Counsel. Both picks would make a lot of sense.

Dorsey previously worked in the FDA Office of the Chief Counsel before leaving temporarily to join the staff of Senate Health, Education, Labor and Pensions Committee Chairman Ted Kennedy. Dorsey returned to the agency last week.

Schultz, if named HHS General Counsel, would be the second former staffer of House Energy & Commerce Chairman Henry Waxman to ascend to a top position in the health department. Schultz previously served as counsel to Waxman on food and health care issues.

He was also deputy commissioner for policy at FDA and a former assistant deputy attorney general. Schultz most recently involved in negotiations over an abbreviated approval pathway for follow-on biologics. As a partner with Zuckerman Spaeder, he was one of four principal negotiators of compromise legislation and represented the generic drug industry in those talks. To read our coverage of FOBs, click here.

Dorsey was also heavily involved in the FOBs negotiations on the Senate side as a staffer to Kennedy.

We'll let you know when we find out more.

FDA Commissioner Decision Coming Today?

A decision on the next FDA commissioner (and possibly other positions) could be made today with an announcement coming a little later.

The timing suggests someone less controversial, possibly a former government official, could be the pick in order to get through the minefield that has become the FDA confirmation process unscathed. Many FDA stakeholders have told the transition team that nominating and confirming a permanent head of the agency is of the utmost importance.

Former FDA Commissioner Jane Henney and former Office of Women's Health Director Sue Wood would likely fit that profile, although both do have issues that could raise a few questions. Henney, for example, sits on the boards of multiple health care companies. To read more, click here. Wood worked on a project related to reauthorization of the Prescription Drug User Fee Act in April 2007, which was funded in part by Pfizer. You can read it here. But we think that is not a big deal in the world of conflicts of interest. The timing, and choice of Bill Corr as HHS deputy secretary, would seem to render the possiblity of former commissioner David Kessler as less of a longshot as well. To read about Obama's choice of Corr, click on our previous post here.

On the flipside, it appears that the nomination of Joshua Sharfstein, Baltimore Commissioner of Health and FDA transition team leader, has encountered serious resistance from two factions: career FDA staff and external groups who are nervous about House Energy & Commerce Committee Chairman Henry Waxman micromanaging the agency through a former staffer. That resistance does not bode well for a candidate like Cleveland Clinic cardiologist Steve Nissen, who has been among the most outspoken critics of the agency.

Still, as we understand it, Sharfstein is down but not out.

If a decision is indeed made today followed by an announcement shortly thereafter, it would likely result in a confirmation hearing sometime in February or early March. That would be a very speedy timeline, given the historical trends.

Check back with the In Vivo Blog and The RPM Report for further updates.

Corr Returns to HHS: Another Piece in FOBs Puzzle

Bill Corr will be Health & Human Services Secretary-designate Tom Daschle’s deputy secretary.

The position requires Senate confirmation. Corr has been an advocate of tougher government controls on tobacco, which often draws the ire of some Republicans in the Senate. As a long-time aide to key Democratic health figures on Capitol Hill (including Daschle), however, Corr’s confirmation is a formality.

In addition to working as chief counsel and policy director for Daschle for two years, Corr has valuable experience within the HHS bureaucracy, acting as an advisor and chief of staff to Clinton Administration HHS Secretary Donna Shalala. He has also been a leader of the Obama HHS transition team, catching up on the broad array of current initiatives.

From biopharma’s perspective, the most important quality that Corr brings to the new position is a familiarity and commitment to an approval pathway for follow-on biologics. Corr was Congressman Henry Waxman’s (D-Calif.) primary staffer for the Waxman-Hatch generic drug law in 1984.

Corr was a forceful advocate for establishing a clear route for quick approval of generics at the end of patent terms as a way to cut drug prices and reduce drug marketing activities – in a period when drug marketing was a pale version of the current level of promotional support.
In fact, despite the rapid success of the Waxman/Hatch legislation in creating a generics drug business, Corr was not pleased by the ability of the program to bring down drug prices rapidly.

He held a hearing two years after the enactment of the law to show that drug companies were still charging high prices. That hearing also showed the unanticipated effect of driving companies to expand dramatically their research budgets (from 8% of sales to around 12-15% of sales) to try to find products to replace products facing generic competition.

Corr won’t be able to devote the same type of focused attention to the development of follow-on biologics legislation, but he will be able to press FDA for action and he won’t need a long-time to learn the ins-and-outs of the issues. There won’t be long delays trying to discuss the philosophy of follow-on biologics at the top level of HHS.

Corr’s appointment may affect the FDA selection process in a variety of ways.
From his Congressional background, Corr shares the most with Josh Sharfstein (head of the Baltimore Health Department). They both served Waxman, though in distinctly different generations: Corr in the late 1970’s and early 1980’s and Sharfstein recently. That connection, however, could cut both ways. There may be subtle reaction against putting too many people recognized as disciples of Waxman in key positions throughout HHS. FDA watchers have already begun speculating that Sharfstein’s candidacy is losing momentum.

By temperament, Corr is closer to the Cleveland Clinic’s Steven Nissen.

Through his commitment to anti-tobacco campaigns, Corr shares a common theme with former FDA Commissioner David Kessler.

The Panetta Formula

What does CIA have to do with the FDA? Not much (we hope) in the normal course of business.

But as the interest and speculation builds about the selection of the next FDA commissioner, there may be a relationship.

President-elect Obama’s selection of Leon Panetta to head the CIA is the connection. Not the man, but the nature of the choice. The CIA selection demonstrates how the Obama team is resolving appointments where there is a clash between key constituency groups. The Obama solution: find an experienced government manager above the fray.

FDA obviously doesn’t have the profile of the CIA appointment; but the position is well-recognized in government circles as one that deserves careful attention. FDA can make a lot of decisions and get embroiled in a lot of health and safety issues that quickly bubble up and catch an administration unawares.

High among the qualities that the new administration is looking for at FDA is strong leadership from a new commissioner. That was one of four qualities cited by HHS-secretary designate Tom Daschle at his January 8 confirmation hearing before Sen. Ted Kennedy’s Health, Education, Labor and Pensions. The new head will make sure that FDA decisions come from evidence and effectiveness, not ideology, Daschle said. The former Senate Majority Leader said that the agency needs strong policy, resources up to par, and coordination.

The administration appears to be looking for someone at FDA who can be sold to the public as being a strong advocate of public health, science and safety – without raising the threat of being an inexperienced crusader (“no impassioned amateurs need apply” - as one advocate for the agency says).

If the search follows that pattern, then the formula for a successful candidate will be an image of experience and unimpeachable public service credentials in someone who can be firm without being controversial. That could negatively affect two of the leading candidates: Cleveland Clinic cardiologist Steve Nissen and Baltimore City Health Commissioner Joshua Sharfstein. That will quietly please some pharma companies that have the limited goal behind the scenes in the selection of trying to make sure that anybody but these candidates gets the top FDA post.

We have been on a soapbox for nearly two years that the agency needs a fresh, forceful leader who will be perceived as tough on industry but at the same time will re-open the door for a period of increased drug development. That sounds paradoxical on the surface, but the tough regulator who is interested in drug development has occurred in the past and could be good for the industry and society. It would be a share if the new administration took the term drug safety and changed that to mean a safe and stolid agency as a way to avert the risk of headline actions.

If FDA experience and gravitas dominate the search, that does lead back to one former tough regulator and drug development advocate: former FDA Commissioner David Kessler. But he was controversial as commissioner, particularly with Republicans on Capitol Hill who faulted him as a turncoat for ostensibly changing his tone at FDA from his time as an aide to Sen. Hatch and for attacking tobacco with a vehemence. He may have a hard time shaking that reputation. He could draw more fire in a confirmation hearing than the FDA position is worth to the new administration.

We have noted previously the recent rise in speculation for another former commissioner, Jane Henney. Her name is re-emerging in a number of general press stories on the post. Henney was never controversial but also may have difficulty filling the role of the strong leader. FDA did approve RU-486 under her tenure and that may be enough to create the image of the leader focused on science and not ideology.

The interest in Henney highlights that there is a lobby to get a woman back at the head of the agency. Here is where another tie between CIA and FDA comes to light: the time for a little FDA-inology (like Kremlinology).From photo analysis and rhetoric reading worthy of the 1960’s, one potential candidate for the position gets a boost -- George Washington University’s Susan Wood. Look back at some of the early Hillary Clinton rallies and you can see Wood standing right next to Maryland Democrat Senator Barbara Mikulski. Similarly, listen to Mikulski at the HELP Daschle hearing. Mikluski is a key figure in the choice for an FDA commissioner: she views FDA as a local constituency.

From Mikulski’s point of view, Wood’s departure from a top staff position at the agency over the delay of Plan B was a sign of the inappropriate politicization of the agency. Wood’s resignation from the agency in 2005 fixed her permanently in the minds of some influential Capitol Hill figures as the emblem of integrity and public spirit that define strong leadership -- maybe that will be enough to earn her the strong, knowledgeable but non-controversial mantle that may be emerging as the formula for FDA.

The Return of Henney?

Great little story from Bloomberg on the possibility of former FDA Commissioner Jane Henney returning to FDA in the same role. To read it, click here. This is just the type of story we love to read, so cheers to Bloomberg on this one.

We heard the rumor about a month ago that Jane Henney, not David Kessler, would be the most likely former commissioner to go back to FDA, but "Jane isn't campaigning for the job," a person close to the transition told us. That may be the perfect strategy to getting the job. Kessler, the person says, still has left too many hard feelings among the Republican leadership on Capitol Hill.

Regarding the Henney situation, what we have heard is there are at least two women's groups pushing for former FDAer and George Washington school of public health professor Susan Wood as FDA Commissioner. As we've reported before, Wood was a big Hillary Clinton supporter. To read our earlier Hillary Clinton's FDA post and get a little background, click here. Wood was co-chair of the women's health policy advisory group during the Obama campaign after Hillary lost, which no doubt improves her chances to lead FDA.

The groups pushing for Wood apparently have Henney as their second choice. As we were reminded by a close friend, that's how Abraham Lincoln became President (read your Team of Rivals, people!).

The crux of the Bloomberg story is this:

"An Obama representative asked Henney, who was commissioner from November 1998 until January 2001, if she was interested in the job, and she said yes, according to a person familiar with the matter."

The name for everyone to remember when it comes to FDA and other major agency positions is this one: Don Gips. The former Level 3 Communications VP is the new director of White House Personnel. There's a little bit on him here. There is little chance anyone will be tapped as FDA commissioner without talking to Gips first. It's possible Henney interviewed with Gips during the campaign (he also helped Obama put together his Senate staff) but we find that unlikely. Gips was just recently named to the job so we doubt he's had a chance to interview many, if any, commissioner candidates.

It's unclear when Obama will name the next FDA Commissioner (you can read our story on the interim commissioner by clicking here.). For example, we know that at least one leading commissioner candidate has yet to be contacted by Gips. We've heard that if the administration wants to act quickly, an announcement will be made at the end of the month or the first two weeks of February and a hearing will be scheduled for April/May. A slower vetting process would mean a Senate confirmation hearing wouldn't occur until Fall 2009.

If the administration goes with Henney, it would be the safe pick. She knows the agency and knows many of the people in leadership positions. She would also generate little opposition. That doesn't mean there wouldn't be any opposition.

Sen. Tom Coburn (R-Okla.) would likely put a hold on her nomination because of her role in approving RU-486. The current University of Cinncinnatti SVP and Provost for Health Affairs also would have to explain her involvement in regulated industry. According to her biography on the site, Henney has served on a variety of boards of directors in the health care field, including the Commonwealth Fund in New York City, the Scripps Research Institute in La Jolla, AmerisourceBergen Corporation in Philadelphia, AstraZeneca PLC in London, the Science Board of MPM Capital in Boston, and the Advisory Group to the Pew Science and Society Institute.

Still, we think she would get through the nomination process. And the folks in Washington policy circles certainly have taken notice that Henney's name is out there.

Changing the Face of FDA...

We couldn't let this news item pass without comment: the first face transplant in the US, performed by surgeons at the Cleveland Clinic.

The patient, naturally is not identified. Perhaps Steve Nissen is taking his campaign for FDA commissioner to the next level? If he looked like Janet Woodcock does he get the job?

Andyisms: A Tribute to Von Eschenbach

In an email to employees this week, FDA commissioner Andrew von Eschenbach announced his resignation from the agency, effective January 20. (Read our take on Andy’s tenure in “The Pink Sheet” DAILY.)

Von Eschenbach joined FDA from the National Cancer Institute in December 2005 as an unflappable, avuncular researcher and cancer survivor who loved to espouse on the future of personalized medicine and the promise of the Critical Path Initiative.

Many of his speeches implored FDA stakeholders to accept and embrace change, usually expressed through one of a collection of metaphors he pulled out for public appearances. And so, to mark his departure from FDA a month from now, we’ve assembled a few of his classics over the past three years. Enjoy.

The Racecar Metaphor:

“One of the rigors of FDA is zero tolerance....I have asked people, do you know how a Formula 1 car can go 200 miles an hour and not kill anybody? Zero tolerance. Everything has to be disciplined and precise—every 'i' dotted, every 't' crossed. But the reason for that rigor and discipline is so the car goes faster, not slower.”

The Typhoon Metaphor:

“To find these moments of change where the change that occurs in that trajectory that the organization is on is not a wind or breeze of change, but a typhoon of change—a strategic inflection in which the change process is magnified in orders of magnitude. And when that kind of change occurs...those that grasp it can then capitalize on it experience exponential growth, and those who don’t understand it, go on to extinction.”

The Hurricane Metaphor:

“There’s a hurricane in the Gulf of Mexico, and since I happen to live in Houston, I think I better pay attention to that, as opposed to, just a little disturbance somewhere.”

The Dirty Diaper Metaphor:

“Creating that future will require change, which will affect all of us, regardless of our role or job title. Unfortunately, the only human organism who actually likes change is a six-month old with a dirty diaper. For most of us, change is what we expect in others.”

The Bridge Metaphor:

“Today we come together as heads of medical product regulatory agencies with the opportunity to collaboratively build a bridge, not a barrier. A bridge that will span the gap between all that promise of science and technology and the delivery of the interventions that can eradicate disease for all of our people. But the bridge must be morphed to accommodate the new science and technology.”

The Locker Room Metaphor, as paraphrased by Sen. Chuck Grassley in a March 12 letter to von Eschenbach:

“I understand that you told the assembled staff that it was important to be ‘a team player’ and that if someone disagreed with the coach, they should keep their opinions and concerns ‘inside the locker room.’ You also said, according to those present, that anyone who spoke ‘outside the locker room’ might find themselves ‘kicked off the team.’”

And finally, our personal favorite: The Butterfly Metaphor:

“In the last decade or two, we have been able to approach disease at the molecular level, where we now can observe and understand disease as a process. This is what I have called the ‘molecular metamorphosis in medicine,’ because it represents a phase change similar to the transformation of a caterpillar to a butterfly. As a result of this metamorphosis, the future of health care will be no more like its past than a butterfly is like a caterpillar.”

Goodbye, Andy. And good luck.

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?

The Long Campaign for FDA Commissioner (Part 2)

Yesterday, we told you about Steve Nissen's presentation during the FDA/CMS Summit for Biopharma Executives.

He wasn't the only speaker at the conference whose name has been mentioned as possible commissioner material. The opening keynote, for instance, was by Janet Woodcock, the head of the Center for Drug Evaluation & Research and the hands-down first choice of biopharma executives to be the next commissioner.

That is the first reason why she almost certainly won't get the job. As we wrote previously, industry support is definitely not something the Obama team is likely to weigh too highly when it gets around to making the pick. Nor is it likely that the new administration will pass up the opportunity to give the plum post to an outsider it would like to reward, rather than to a career FDAer, even one as abundantly qualified as Woodcock.

Indeed, the day before Woodcock spoke at the Summit, Rep. Bart Stupak (the chair of one of the Congressional committees that oversees FDA) wrote to the President-elect to declare that no agency insiders should be considered for the post even on an interim basis. Stupak, as "The Pink Sheet" reports, wants "a complete change in FDA's leadership."

Stupak, as it happens, chose the losing side in an internal Democratic party fight over leadership of the Energy & Commerce Committee, so his opinion may not carry as much weight as it once would have. But we're betting that the transition team won't be looking to antagonize Stupak unduly by nominating Woodcock for the job.

As for giving her the post on an interim basis, not only would that antagonize Stupak, but it would probably do exactly the opposite of what her supporters want: if Woodcock is the acting commissioner, she would almost certainly leave the agency once a Senate confirmed commissioner comes on board.

So who will the next FDA commissioner be?

We're betting that the closing speaker at the Summit, FDA deputy commissioner Frank Torti, will end up claiming that title--albeit only on an acting or interim basis. That, at least, is what the natural order of things would dictate, a fact that has been clear since Torti joined the agency six months ago.

And after that? Well, that's what campaigns are for.

Stay tuned: On Monday we'll bring you Part 3 of our campaign-for-commish series.

The Long Campaign for FDA Commissioner (Part 1)

Who says Election season is over?

To us, it sounds like the campaign to run the Food & Drug Administration is just heating up. That, at least, is our impression after FDC-Windhover’s FDA/CMS Summit for Biopharma Executives last week.

Exhibit A: The presentation by Cleveland Clinic cardiologist Steve Nissen. As always, Dr. Nissen was energetic, engaging and pretty frank in calling ‘em as he sees ‘em. But we heard some things that sounded a bit different than we have heard before.

As “The Pink Sheet” reports, Nissen—who, with some understatement, observed that he is no fan of the Prescription Drug User Fee Act—nevertheless declared that, having taken the money, FDA needs to follow through by offering an answer in the agreed upon timeline. That isn’t going to make Nissen any new friends at FDA. In fact, Office of New Drugs Director John Jenkins spoke earlier in the day and delivered a passionate defense of the agency’s review performance in 2008, and he sat stoically through Nissen’s presentation.

But some of the industry folks in the audience must have been whispering “amen” under their breaths. Our unscientific read of conference attendees is that they are sympathetic to the challenges facing FDA’s review group, and wary of piling on the agency at the this moment in its history—but they agree with the principle that, given how much they pay in user fees, FDA ought to be able to give them an answer on time.

And we bet one company in particular agrees: Nissen singled out Lilly’s overdue application for prasugrel (Effient) as both a case where the agency owes the sponsor an answer one way or the other. (If you haven’t followed the ins and outs of that application, start here.)

Nissen also declared that FDA’s “core” problem is that it lacks the resources to fulfill its mission—and stressed his view that a strong, credible FDA commissioner will help the agency secure those resources from Congress. (Oh, and he let slip that he had just been up on Capitol Hill himself that morning, chatting with some of his friends in Congress.)

Last but not least, Nissen endorsed the call for a fixed-term for the FDA commissioner (five or six years) to help depoliticize the agency’s leadership. That, to our surprise at least, has become a rallying cry for Big Pharma in the weeks since the election, with CEOs like Schering-Plough’s Fred Hassan and Pfizer’s Jeff Kindler highlighting the idea in appearances before investors.

In other words, Nissen sounded a lot like someone hoping to win some industry support for the FDA job...or at least convince some people not fight too hard to block him.

When asked specifically whether he has his eye on the commissioner post, his answer was “no comment.”

But it was what Nissen said afterward that really caught our attention. “I am going to stay engaged in these issues,” he said. “As an advocate for patient safety, I want to be engaged one way or the other.”

One way or the other? Hmmmm.

Nissen then went on to describe his ideal candidate, and frankly, it sounded an awful lot like him. First, a commissioner should be a physician, “because if you haven’t ever taken care of patients, you don’t really have the necessary perspective.” Check. Nissen is a cardiologist at the Cleveland Clinic.

Next, the commissioner should be a “good scientist,” because the FDA has to be a science-based organization, and “decisions have to be made upon the basis of evidence.” Check. Nissen is deeply involved in pharmaceutical research with a host of drug companies (the money from which, he is quick to point out, is donated to charity without a tax break for him).

The FDA commissioner also “ought to know something about statistics.” Check. As Nissen was quick to point out, he presented a series of statistical slides during an advisory committee meeting in July on the approval standards of diabetes drugs.

Finally, he said, FDA needs a commissioner who is “passionate about the public interests.” Check. Nissen’s critics may question whether he is also passionate about his elevating his public profile, but there is no question that he has patients’ interests at heart in his self-appointed position as a drug safety advocate.

Now, bear in mind that just because Nissen (and others) are campaigning for the job doesn't mean that a pick is anything close to imminent. The new Administration has a lot on its plate, and (as we wrote here) FDA isn't even close to the top of the list. But the Obama team knows a thing or two about long campaigns, so we say: bring it on.

Tomorrow: a word from (and about) some other candidates at the FDA/CMS Summit…

--Michael McCaughan and Kate Rawson