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.)

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.