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.

Drug Safety...or Food Safety...or Tobacco Safety...or Pet Food Safety...or Dietary Supplement Safety?

So which is most important to you? Well, if you're in charge of FDA, they all are. That came through loud and clear during a health care reporters breakfast with commissioner Andrew von Eschenbach organized by the folks at Health Affairs.

But fortunately for us here at the IN VIVO Blog, we only have to worry about drugs and biologics. With Congress taking off for their August recess, it looks like the Prescription Drug User Fee Act reauthorization as part of the much grander FDARA drug bill will have to wait until September to get passed.

So wait, doesn't that mean droves of FDA employees will be out of a job come September 1st because there will be no money to pay them (FDA gets half of its drug review budget from user fees)? Not so much. Von Eschenbach said the agency has already dipped into "carry-over" funds to ensure the agency will run smoothly while they wait for lawmakers to act. He expects/hopes the bill will pass in the first few days when the House and Senate come back from recess. Von Eschenbach emphasized he was working very closely with specific players in Congress to make sure that happens. The "carry-over" money, which seems to have magically appeared, is enough to last a couple of months before FDA would have to send out lay-off notices.

The RPM Report will be hosting a webinar on August 14 in partnership with the law firm Ropes & Gray to explain the commercial impact of the new drug safety rules for pharma and biotech companies. This will be the first in a series of audioconferences on the pending drug safety reforms.

The Wrong Man for This Job

Sometimes the right person comes along at the wrong time. Unfortunately, that appears to be the case with Dr. Andrew von Eschenbach and his stewardship of the Food and Drug Administration.

Von Eschenbach was persuaded to come over from the prestigious National Cancer Institute to take the helm at FDA during troubled times. He answered the call to duty. His predecessor, Lester Crawford, pled guilty to two misdemeanors for withholding financial information related to food and drug stocks he owned (I wish I was making this up) and the public had lost trust in one of the most important federal agencies in the country. He seemed like the perfect choice to usher the agency through the final years of the Bush Administration.

With the Vioxx controversy seemingly behind the agency, it seemed like FDA had somewhat smooth sailing ahead for the twighlight years of Bush II. Uh, not so much. Results from the Institute of Medicine study on drug safety, the controversies over Sanofi-Aventis' antibiotic Ketek and GlaxoSmithKline's diabetes drug Avandia, and the re-emergence of whistleblower David Graham, among others, contributed to chipping away at FDA's credibility.

Now, more than ever, FDA needs strong leadership. And by strong leadership, I mean an authoritative voice with a clear message. I wrote a piece on this very subject in the June issue of The RPM Report. I'll let you judge for yourself: if you want to read it, click here, and as always, I would love to hear what you out there in the blogosphere have to say.

One of the misconceptions about this issue is that it's an inside-the-beltway issue. Wrong. This is a commercial issue for the pharmaceutical and biotech industries. Don't believe me? Look what the article of one clinical researcher did to GSK's stock. Would the stock have dropped billions in market cap if the docs, the media, the public and the investment community trusted FDA as the final word on drug safety? No doubt, Glaxo's stock price would have taken a hit, but a $13 billion hit in one day?

And that's why, in my opinion, FDA's credibility gap-real or perceived-ranks as the number one business problem for drug manufacturers for the foreseeable future. The credibility gap has infused arguably unprecedented unpredictability into the drug development system, and until it is somehow fixed, that unpredictability will hover over the agency, and only loom larger.