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.

Frank Torti Tapped As Acting FDA Commissioner

Drum roll, please….The next commissioner of the Food & Drug Administration will be chief scientist and principal deputy commissioner Frank Torti.

According to an email message sent to HHS staff on Friday evening, Torti will become acting FDA commissioner come Inauguration Day, once Andrew von Eschenbach leaves office. Torti will serve under President Barack Obama until a permanent successor is named.

The announcement comes more than a week before the transition will take place. After 300 meetings with department and agency staff, HHS chief of staff Rich McKeown said in the email message, “the next phase of Transition involves the departure of our team on January 20, and the arrival of President-Elect Obama’s team later that day.”

“In order to create a clear path for leadership transition, I am attaching a list of senior leaders who will become the acting heads of their respective agencies and offices (or in some cases, remain as heads of their respective agencies and offices) until the new Administration appoints individuals to various leadership positions.”

HHS secretary Michael Leavitt will leave the department once President-elect Obama takes office. Assistant secretary Charlie Johnson will lead the department until Secretary-designate Tom Daschle is sworn in. “Once Secretary-designate Daschle is confirmed by the Senate and sworn in as HHS Secretary, he will assume leadership of HHS,” McKeown’s email says.

Once that happens, Daschle is expected to quickly announce his picks for the heads of each agency. At his Senate confirmation hearing last week, Daschle said that the Obama transition team had been aggressively interviewing candidates, and that he hoped to start building his new leadership within the next few weeks. (We've filled up the ethernet with quite a bit about potential commissioner candidates; you can start here, here and here).

But at least for now, Torti will be The Man at FDA. So what do we know about him? If you attended FDC-Windhover’s FDA/CMS Summit for BioPharma Executives in December, then you heard his keynote address first-hand. But if you missed it, you can check out this story from “The Pink Sheet.”

But we can’t help but point out that we called this one back in June—despite rumblings from Torti’s colleagues at Wake Forest that he would be returning to academia as soon as the next president took office.

In many ways, Torti is the logical pick: under the Federal Vacancies Act, Torti’s position as principal deputy commissioner puts him in line to become acting commissioner once von Eschenbach departs. Having joined the agency less than a year ago, he carries no baggage. And he comes from an academic (not political) background—the perfect profile for a caretaker commissioner.

But as recently as early December, Torti had not yet been approached about the job—at least not to the point, he said, where he would have to sit down with his wife and discuss a longer stay in Washington than was originally planned. But, hey, a lot can happen in a month.

Here are some of the other top-level acting positions announced by HHS:

The Centers for Medicare & Medicaid Services will be headed by chief operating officer Charlene Frizzera; acting CMS administrator Kerry Weems will step down;

The Centers for Disease Control & Prevention will be led by chief operating officer William Gimson; current director Julie Gerberding will leave office;

The National Institutes of Health will continue to be led by acting director Raynard Kington;

The Agency for Healthcare Research & Quality will continue to be headed by director Carolyn Clancy; and

The Office of the Surgeon General will continue to be held in an acting capacity by Steven Galson (more on his future plans here).

Gupta in for Galson: What's Next for Former FDAer?

Anyone looking at the FDA public calendar this week (who doesn’t love to keep track of the comings and goings of government officials?) may have noticed something peculiar: Steven Galson, the former director of the Center for Drugs, was listed as an FDA participant in a recent meeting at the agency.

According to FDA’s website, Galson joined FDA commissioner Andrew von Eschenbach and Center for Drug Evaluation & Research director Janet Woodcock at a “meet and greet” with the University of Florida officials at FDA’s Silver Spring headquarters on December 17. Galson and Woodcock are listed as “other FDA participants.”

There are a lot of changes expected in FDA leadership in the next few weeks, but Steve Galson’s return to the agency was not one of them. So naturally, we were a bit curious. Could Galson, who left CDER in October 2007 to become acting US Surgeon General, be returning to FDA? Or did the agency’s webmaster err in including him on the calendar?

We reached out to Galson to ask him to explain. It turns out he was invited to participate in the closure of an agreement between FDA and the University of Florida on a new fellowship program. That program, which is designed to bring fresh blood into FDA, is a pet project of von Eschenbach’s and one that his principle deputy commissioner, Frank Torti, has been overseeing since joining FDA last summer.

Galson was invited not in his capacity of a former FDA official (despite what the public calendar says), but because the Florida deal involves officers in the Public Health Service, and as acting Surgeon General, Galson is the Commander of the Commissioned Corps. (He’s also a Rear Admiral.)

But that doesn’t necessarily mean that a return to FDA isn’t in the cards. Galson is expecting to be out of a job in the next few months: according to the Washington Post, President-elect Barack Obama has offered the Surgeon General position to prominent neurosurgeon and television talking head Sanjay Gupta.

Galson is a career government official—not a presidential appointee—so he's not expected to be immediately asked leave the Surgeon General’s office once Obama takes office. But with Gupta as the apparent pick as his successor, it looks like Galson will be looking for another job in the next few months. So what’s next for the former FDA official?

Galson says “is not ruling out any possibilities”—including a potential return to FDA. His next move, Galson says, will depend on how certain appointments come out (presumably the FDA commissioner spot), but he's “looking at all options.”

We’re sure Galson has lots of options—in addition to FDA, he has held senior-level positions at the Environmental Protection Agency (as head of the Office of Science Coordination & Policy) and Department of Energy (as chief medical officer) and worked earlier in his career at the Center for Disease Control and Prevention.

But Galson did join FDA specifically to help the agency revamp its postmarketing surveillance program. That was in 2001, and the agency is still revamping its postmarketing surveillance program. We're just speculating here, but maybe that “meet and greet” at FDA will be the start of Galson's next career move.

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.

Transitioning to a New FDA: What's Next for Von Eschenbach?

As Barack Obama said at his first press conference as President-elect on Friday, there can only be one president at a time. Likewise, there can only be one FDA commissioner at a time.

While there’s been a lot of speculation about who might take the reins from Andrew von Eschenbach (see our picks here and here), there hasn’t been a lot of talk about the plans of the current commissioner. When will he leave? Where is he headed? Who will fill in for him until a permanent replacement can be found?

Von Eschenbach himself has remained mum on his post-FDA plans, but we’ve heard that a deanship is in the works—potentially a return to the University of Texas MD Anderson Cancer Center in Houston, where he served as VP and chief academic before being named director of the National Cancer Institute in December 2000.

One thing appears clear: von Eschenbach will tender his resignation before Obama takes office, probably sometime in December, and will leave the agency soon after January 20. That is the typical protocol for presidential appointees--or at least for those not named David Kessler (the one FDA commissioner holdover since the 1950s). FDA officials have been preparing for the transition to a new Administration for months.

Given that the selection of an FDA commissioner is pretty far down Obama’s to-do list, von Eschenbach’s departure will involve a temporary replacement for at least the near-term. Recall that during the last transition after President Bush took office in 2001, it took until early 2002 before Lester Crawford was named acting commissioner, and until November before Mark McClellan was sworn in.

So whomever is named acting commissioner when von Eschenbach leaves could remain in that position for some time. As much as the pharmaceutical industry would like that temporary head to be Center for Drug Evaluation & Research director Janet Woodcock, FDA chief scientist Frank Torti is a more likely pick.

But despite what you may have heard, FDA says von Eschenbach's departure is not imminent. We asked the commissioner’s office about reports that von Eschenbach is packing his bags, and here’s what a spokesperson had to say:

“The FDA Commissioner serves at the pleasure of the President. As protocol dictates, all senior political appointees submit their resignation to the President who appointed them at the conclusion of the Presidential term.

Commissioner von Eschenbach will remain deeply engaged and sharply focused on leading the Agency in accomplishing its mission of protecting and promoting the health of the American people every single day of his service, until the very last day, whenever that may be.”

It Doesn’t Always Pay to Work at FDA

When FDA commissioner Andrew von Eschenbach testified during his confirmation hearing in front of the Senate Health Committee in 2006, he pointed to one area on which he would be dedicating plenty of attention: employee morale.

“Attention to our workforce is my number one priority. It is the most precious asset that FDA has,” von Eschenbach told Sen. Barbara Mikulski (D-Md.) during the hearing. “Improving and enhancing retention and recruitment opportunities, career development opportunities will also address morale.”

Turns out one detail may have been overlooked. Someone forgot to, um, pay everyone on time.

So, at least, says Senator Chuck Grassley. He claims that FDA has some serious issues with its payroll system. Some employees aren’t getting paid, while other are being overpaid by thousands of dollars. That kind of “sloppy record keeping,” Grassley says, has “shaken confidence in the personnel management system.”

“I am very concerned that payroll problems are adversely affecting employee morale and work performance at the FDA,” Grassley says in an October 28 letter to von Eschenbach and HHS secretary Michael Leavitt. One FDA employee, he says, went to the emergency room in the middle of the night with a sick child, only to discover that FDA had incorrectly terminated him, thus cancelling his health insurance benefits.

“On at least two occasions employees may have been mistakenly overpaid by several thousand dollars,” while in another case, “a brand new employee at the FDA was not paid for several pay periods because the employee ‘fell out of the system,’” the letter says. Grassley is requesting that FDA submit all wage- or benefit-related complaints filed since January 2006.

This isn’t the first time that FDA pay practices have attracted congressional attention. House Energy & Commerce Committee Chairman John Dingell and Oversight and Investigations Subcommittee Chairman Bart Stupak have both complained about FDA awarding excessive bonuses to its highest paid employees, while not making a greater effort to retain employees with a scientific function in the agency.

And low morale has been a persistent problem at FDA. An understaffed agency that is always under a threat of whistleblower actions and intense scrutiny from Congress over issues like drug safety doesn’t always make for a pleasant place to work. And unhappy FDA employees aren’t good for drug sponsors—especially if disgruntled reviewers leave before an NDA is approved.

Indeed, Mikulski’s line of questioning for von Eschenbach in 2006 was prompted by a survey released a month before by the Union of Concerned Scientists that found low morale among many FDA employees due to a perceived lack of support from top agency officials.

Even before his confirmation hearing, von Eschenbach talked about his commitment to turn “FDA into an efficient, modern, performance-based organization” with an emphasis on improving “business” operations. And he later named the agency’s first-ever chief operating officer, John Dyer, to focus on “strengthening the management, business processes, and information technology of the agency.”

But as Janet Woodcock, the director of the Center for Drug Evaluation & Research, put it earlier this year, all FDA employees really want are the basics: an opportunity for professional development, good communication from the top, and—believe it or not—decent parking.

Of course, getting paid would be a plus, too.

FDA Hires a PR Firm to Tarnish its Image

It’s only appropriate that on the day of the Vice Presidential debate, Alaska Newspapers Inc. is making front page news.

But it’s not for the reason you may think.

The Washington Post has a top story today on how FDA circumvented the government competitive contracting rules in order to ensure that Qorvis Communications received a $300,000 public relations deal.

Alaska Newspapers served as the middleman. How’s that, you ask?

The group doesn’t have to compete for federal contracts because it qualifies for special set-asides. So, ANI would get the deal and hand it off to Qorvis. And that’s exactly what they did, according to the WashPost.

FDA deputy commissioner for operations John Dyer, a former CMS official, said in the story that the contract has been suspended and that the agency has launched an internal investigation.

FDA Commissioner Andrew von Eschenbach and other senior officials did not know about the no-bid contract, Dyer says in the story.

Von Eschenbach has been besieged with criticism of the agency from various sides for two years. He must be feeling the wear and tear but this is the kind of project that should have been brought to his attention.

It would be a good idea for the commissioner to know the FDA had hired the same PR firm that works for PhRMA “to create and foster a lasting positive public image of the agency for the American public,” as the Washington Post describes.

As I recall, FDA’s perceived “cozy” relationship with the drug industry has been an issue of public concern lately.

The fact that the FBI raided Qorvis for work the company did on behalf of the Kingdom of Saudi Arabia back in 2004 probably should have raised a red flag as well when it came to choosing the right firm. Is there a PR company shortage I was unaware of?

Former FDA associate commissioner for external affairs Peter Pitts has some interesting behind-the-scenes insight on outsourcing PR. To read it, click here.

This most recent development has four major impacts on FDA:

1) Further supports the public perception that FDA is dysfunctional.

2) Undermines the leadership of von Eschenbach. Where was he on this thing?

3) Needlessly stigmatizes FDA by lumping the agency with other politicized no-bid contracts. Is FDA synonymous with Halliburton?

4) Triggers yet another Congressional probe by the House Energy & Commerce Committee.

Chairman John Dingell (D-Mich.) says his committee will investigate the matter, which could result in a high-profile hearing. Here’s what happened last time von Eschenbach went up to Capitol Hill.

It's a sign of FDA's fortunes when the agency goes out of its way--and budget--to hire a PR firm to improve its public image, tarnishes its image in the process, gets a Congressional investigation out of it, and still doesn't have a PR agency.

Frank Torti: FDA’s Next Commissioner?

FDA Acting Commissioner Frank Torti. It kind of has a nice ring to it, don’t you think? Given some of the things we’ve been hearing inside the Beltway recently, it may just come to pass.

Torti came on board as FDA chief scientist and Andy von Eshenbach’s second in command in April. At the time, we commented on the choice of an academic as Janet Woodcock’s successor, and Torti as a particularly non-controversial pick.

But the early word—at least from his colleagues at Wake Forest—was that Torti wasn’t long for the job, and that he’d be returning to academia as soon as the next president took office.

Some industry observers are now speculating that Torti’s tenure at FDA will be a lot longer than first thought. Conventional wisdom inside Washington has held for some time that von Eschenbach’s tenure is winding down, and that he will be asked to leave FDA the morning of November 5, regardless of who ends up in the White House.

Once that happens, Torti is likely to be asked to hold down the fort until von Eschenbach’s permanent successor is named. And depending who takes over the White House, Torti very well could be that permanent successor. That shouldn't come as much of a surprise: von Eschenbach himself was only supposed to be a temporary replacement when he came on as interim commissioner in late 2005.

Either way, Torti is someone that industry should get to know. If you’re looking for some insight into Torti’s policy plans, his May 30 appearance at the FDA Science Board might be a good place to start. You can find a partial transcript of his presentation through The RPM Report by clicking here; if you don’t subscribe, you can sign up for a 30-day trial to view the article.

In it, Torti outlined his plan for his first 100 days as FDA’s chief scientist, very much sounding like someone who is ready and willing to settle into the job for the long haul—at least until he is called up for higher service. Even the title of his speech had a political ring to it: “Science at the FDA: Vision, Plans and Timetable.”

At least for now, Torti is being coy about his future plans at FDA. When our colleagues at “The Pink Sheet” asked him about the rumors surrounding his tenure at the agency, he smiled and said, “I’m not in the habit of taking a job no one’s told me about yet.” Perhaps not. But we have a feeling his phone will be ringing soon.

Why Von Eschenbach Bucked Bush: The Fight Over FDA Funding

As the New York Times reported earlier this week, FDA commissioner Andrew von Eschenbach did what has never been done before in the 100-plus years of the agency: he wrote a letter to Congress asking for more appropriated dollars for FDA.

Given the number of unfunded mandates handed to FDA over the years—and the recent demands on drug safety and overseas inspections—it should come as a surprise to no one that the agency is underfunded.

But for the FDA commissioner to make such a direct request to Congress for more money is an earth-shattering move: especially this commissioner who has shown a willingness to take a lot of criticism and abuse for defending Administration positions.

FDA has historically remained in lock-step with senior Administration officials over budget requests. The agency traditionally defers to a number of higher power centers on budget issues, including the budget enforcers at the Office of Management and Budget. Never before has an FDA commissioner publicly asked for anything from Congress that is at odds with what is in the president’s congressional budget request, in this case a 3% increase for fiscal year 2009.

But in a May 5 letter responding to a request from Sen. Arlen Specter (R-Penn.), von Eschenbach broke ranks with the White House and did just that. Specter is the ranking member of the Senate appropriations subcommittee that oversees HHS’ budget.

Using carefully worded language, von Eschenbach said that in his “professional judgment” and “without regard to the competing priorities,” FDA could use an additional $275 million in funding. The letter creates a new version of the Washington ruse of “plausible deniability.” By stressing that it is his professional judgment, von Eschenbach can continue to sound like a committed (professional) manager of FDA while denying that he is second-guessing his bosses.

Much has been made of the letter, but as earth-shattering as the request was, it didn’t come out of nowhere. Rather, it was the culmination of a series of baby steps taken by von Eschenbach over the last several months.

To Steven Grossman, deputy executive director for government relations and communications at the Alliance for a Stronger FDA, the “visible transition point” came during an Energy & Commerce Oversight & Investigations Subcommittee hearing January 30. The 180-member Alliance for a Stronger FDA has been lobbying for additional dollars for FDA; we wrote about the group in a story in The RPM Report here.

The hearing was called in response to an FDA Science Board report that detailed numerous deficiencies in the agency’s ability to meet its scientific mission. As we reported in an earlier post on the IN VIVO Blog, subcommittee chairman Bart Stupak repeatedly asked von Eschenbach whether the Administration’s budget proposal for FY 2009 was sufficient to meet FDA’s needs.

The commissioner demurred, noting that at the time, President Bush had yet to release the budget request. But as Grossman points out, von Eschenbach showed some fissures in his resolve to stick to the party line: he acknowledged that the budget was less than what he had requested from the Administration for FDA.

A month later, von Eschenbach conducted an interview with Wall Street Journal, in which he sought to correct a misperception that he didn’t think FDA needed more resources. That story was followed two days later by a keynote address at the National Press Club. (We wrote about that shift in von Eschenbach’s public comments about FDA resources in an earlier blog post here.)

After that, von Eschenbach appeared to take a couple steps backwards, first telling the Senate appropriations subcommittee on April 15 that FDA couldn’t absorb the $375 million in funding included in the Senate budget resolution. A week later, it took a long and heated exchange with Rep. John Dingell during an Oversight & Investigations hearing for von Eschenbach to acknowledge that FDA needed $70 million for overseas inspections.

So what made von Eschenbach finally publicly admit what everyone else seems to have known for a long time? We don’t claim to have any specific insight into what the commissioner was thinking, but there are a few things worth pointing out.

First, von Eschenbach and Sen. Specter had an amiable relationship long before the commissioner moved to FDA. Specter served as the chairman of the appropriations subcommittee while von Eschenbach was head of the National Cancer Institute. The two are also cancer survivors: Specter was diagnosed with Hodgkin’s disease in 1995, and von Eschenbach is a survivor of melanoma and prostate cancer.

Given that relationship, Sen. Specter may have been one of the few congressmen able to give von Eschenbach a way out of FDA’s budget crunch. In his letter to the commissioner, Specter wrote by hand in the margin, “Andy, I know the situation is extreme. I want to get you financial help now,” according to the Times.

And it’s also worth mentioning that other federal agencies have recently broken ranks with the Administration over budget requests. Last year, Julie Gerberding, head of the Centers for Disease Control & Prevention, issued a strongly-worded letter to Congress about its budgetary needs—in language much less diplomatic than von Eschenbach’s.

Much has been already written about how the letter marks the waning influence of the Bush Administration. While that may be true, it’s just as likely that von Eschenbach simply grew tried of trying to defend an indefensible situation. To the growing number of groups seeking more funding for FDA, it would be nice if von Eschenbach’s letter leads to some real money.

Boehm bucking broncho at Madison Antiques and Gifts.

Dingell vs. Von Eschenbach = Fireworks

Apparently, House Energy & Commerce chairman John Dingell is unhappy with the Food & Drug Administration.

The Michigan Democrat took issue with FDA commissioner Andrew von Eschenbach's broad plan to overhaul the agency's overseas drug inspection structure to avoid another heparin situation during an E&C Oversight and Investigations Subcommittee hearing. Von Eschenbach was trying to explain that it's not just the number and frequency of inspections by inspectors, but how the inspections are carried out that matter.

Dingell was having none of what he called the commissioner's "toe dancing." Dingell, during his allotted time for question-and-answer, asked von Eschenbach to answer "yes" or "no" to a series of questions. The commissioner started off obliging Dingell but then began getting off track with longer, more verbose answers.

Dingell: I'm going to be honest with you, I'm establishing that you don't have the resources and you can't do your job.

The Energy & Commerce chairman asked if the $11 million for 2008 and $13 million for 2009 allocated for inspections was enough for FDA to inspect the thousands of currently uninspected facilities abroad which import food and drugs into the US every year.

Dingell: Does FDA need more resources to conduct inspections.

Von Eschenbach: Yes, sir. I've asked for more resources.

Dingell then pointed out that the Government Accountability Office estimated it would cost $16 million to inspect only Chinese exporters. So clearly, the $11 million and $13 million were not adequate, right?

Von Eschenbach paused and then answered: I'm telling you that we are putting [the resources] to appropriate use and I have requested additional resources to do more but I'm trying to make the point that in addition to doing more, we have to do it differently.

That set off Dingell, and recalled the Michigan Democrat's days when he skewered witnesses without mercy.

Dingell: You know, I've been in this business a long time, and I've had food and drug commissioners constantly tell me, 'Ooooh, we're going to have a new means of doing this, and we're going to be leaner and meaner.' Turns out that they're leaner and poorer and weaker and less capable of doing their jobs. And all of these promises that I get from commissioners...turn out to be nothing more or less than hooey.

Von Eschenbach: Mr. Chairman, if you allow me to...

Dingell: I didn't fall off the cabbage wagon yesterday. I've been talking to food and drug commissioners for 40 years. And you're not the first fella I've had to skin for not doing his job and coming up here and defending an indefensible situation. I want to maintain my respect for you but I can't maintain my respect for you if you keep toe dancing around the hard facts that curse you with the inability to do your job because you don't have resources.

Then Dingell asked von Eschenbach repeatedly exactly how much money FDA needs to inspect all of the outside facilities up to a US standard.

Dingell: I'm rather tired of all this toe dancing. You cannot do your job, you are not doing your job, how much money do you need to do it?

Von Eschenbach responded that he would have to submit a business plan to appropriately address the question but added that a rough estimate would be the number of total facilities multiplied by $45,000 (the GAO estimate per inspection).

That wasn't good enough for Dingell. "You are carrying water for an administration that has not given you the resources that you need. This committee wants you to have the resources that you need to do the job you have to do to protect the American people." He then brought up the deaths and adverse events related to Baxter's contaminated heparin. And started shouting. "You presided over this because you do not have the resources to do the job that you need to do. How much money do you need to do the job that you are supposed to do?"

Von Eshenbach remained calm and answered again in a way that did not calm Dingell's tone: "Mr. Chairman, I would like to have the resources that would enable us to do a systemic overhaul of the entire process, not a figure that's related to a cost per inspection times the number of facilities."

Dingell repeated again and again, slamming his hand against the desk, the question of exactly how much money FDA needed for the overseas inspections. "You have one fine scandal going on, you have others going on with regards to fish and fish products and you simply are absolutely incapable of addressing your responsibility."

In the end, von Eschenbach gave him the round figure for drugs: 3,000 facilities times $45,000 per site, which is $135 million. However, the sites are inspected once every two years, so the number really is about $70 million. The Republican Senate staff would later say it would take about 500 FDA inspectors overseas.

Dingell ended his fire and brimstone delivery with this: "Commissioner I have no ill will towards you. I have ill will of the most gross sort towards the fact that you come up here and defend a situation that is indefensible and that you are not soliciting the resources that you need to do your job to protect the American people the way the law says you should. And that you are tolerating an administration which is allowing this kind of situation to [continue] because they are too damn tight."

Von Eschenbach, for his part, handled himself well in the face of such a storm from Dingell and remained calm-not an easy thing to do considering the circumstances. But maybe next time, he should just say: $70 million.

Tort(i) Law: A Safe Pick for FDA

Perhaps the most significant thing to say about FDA’s new chief scientist is that there isn’t much significant to say about him.

In Frank M. Torti, a cancer researcher and professor at Wake Forest University School of Medicine, Andrew von Eschenbach appears to have selected a safe second-in-command during what has been a tumultuous time for the agency—an academic who is well-respected in his field and without apparent ties to industry.

As we pointed out previously, by choosing a non-confrontational academic to fill the vacant deputy commissioner post, von Eschenbach leaves open the possibility that the official might stay on at FDA under a new Administration, thereby extending the commissioner’s legacy after he leaves the agency.

But is Torti long for the job? According to his Wake Forest colleagues, the FDA appointment is more of a sabbatical than a permanent gig. Jerry Garvin, MD, who was named interim director of the cancer center in Torti’s absence, told the Winston-Salem Journal that he expects him to return to Wake Forest within nine months to a year. “He’s coming back,” Garvin told the paper. “Thank goodness.”

Of course, von Eschenbach originally joined FDA on what was assumed to be a temporary basis back in 2005, so maybe Torti will learn to love the position.

A initial focus of Torti’s role will be overseeing an important and relatively uncontroversial human resources initiative: FDA’s two-year fellowship program designed to attract and retain quality regulatory and scientific professionals.

The FDA Fellowship Program is a priority for von Eschenbach before he leaves the agency; the commissioner has been talking it up in recent appearances in Washington. The program will help FDA hire the 700 new people needed to fully staff the agency while at the same time helping to create a constituency empathetic to FDA’s challenges.

Torti’s office will also “work to ensure the quality and regulatory focus of the intramural research programs of the agency, and place special emphasis on the importance of clinical research trials that are a part of the foundation of the FDA’s regulatory structure,” the agency said.

It’s a vastly different set of responsibilities than those of Torti’s predecessor as deputy commissioner, Janet Woodcock. Before Woodcock became director of the Center for Drugs Evaluation & Research in March, the career official was all things to FDA: advocate for personalized medicine, champion of the Critical Path Initiative and chief implementer of the FDA Amendments Act.

In Torti, von Eschenbach has chosen a deputy commissioner with a background similar to his own. As the director of the Comprehensive Cancer Center at Wake Forest Medical Center, Torti specializes in genitourinary cancers. Von Eschenbach is himself oncologist and urologist, and is the former head of the University of Texas M.D. Anderson Cancer Center.

They also both have some experience in government service at the National Institutes of Health. Von Eschenbach served as head of the National Cancer Institute before joining FDA, while Torti is a member of NIH’s National Advisory Council for Complementary and Alternative Medicine.

So, OK. Maybe there are some things of significance to say about von Eschenbach’s newest hire. But unless we’re way off base here, it’s doubtful that the Torti Tenure will be too exciting for FDA—which is probably just what the doctor ordered.

FDA’s 12-Step Program

The first step in any recovery is recognizing that there is a problem.

Based on a recent shift in public comments, it sounds like FDA Commissioner Andrew von Eschenbach has accomplished that important first step in a recovery program for the agency: he is now acknowledging publicly what others have been lamenting for some time—that FDA has reached a crisis point in its ability to complete its mission with its available resources.

While von Eschenbach says he first recognized the resource issues soon after joining the agency, he is starting to become more forceful and use stronger language than in previous public appearances.

The change in tone began with an interview that appeared in the Wall Street Journal on February 27, in which von Eschenbach sought to correct a misperception that he didn’t think FDA needed more resources. He followed that with a keynote address two days later at the National Press Club, during which he talked about the “potential for tremendous peril” during a time that he referred to as a “turning point” for FDA.

But the real change seemed to come during what is likely to be von Eschenbach’s final keynote at the Food & Drug Law Institute’s annual meeting last week. Using a term he has largely avoided in the past, von Eschenbach acknowledged that the agency is in the midst of a “crisis” as it struggles to meet all its responsibilities on a shoestring budget.

“This agency is burdened with an enormous portfolio of responsibilities of incredible scale and scope that have been growing over time,” he said. “And they have been growing in a manner that is somewhat akin to children putting ornaments on a Christmas tree. Each one of them maybe very important but the process was done without planning without precision and without prioritization.”

That increase in regulatory mandates is “further complicated by one more catastrophic element added to this formula for potential disaster,” he said. “All of this in context of uncontrolled expansion and accelerating complexity compounded by in effect reduction in resources available at FDA with which to cope with these changes.”

Those reductions—which prevented FDA’s budget from keeping pace with inflation—“were so subtle that when one looks at the bottom line, there was an apparent deception,” von Eschenbach said. The agency’s work force appears adequate on the surface, but in reality is overextended, aging, unstable and “working and coping with inefficient tools.”

Those statements come in stark contrast to von Eschenbach’s testimony during House Energy & Commerce Oversight & Investigations Subcommittee hearing just two months ago. The hearing—called by subcommittee chairman (and persistent thorn in FDA’s side) Bart Stupak—discussed an FDA Science Board report released late last year that described an agency “at risk” and unable to meet its scientific mission.

Von Eschenbach was asked to comment on the findings, and whether the agency needed more money to complete its mission. The commissioner chose his words carefully: while acknowledging that he had asked HHS Secretary Michael Leavitt for more appropriations for fiscal year 2009, he refused to specify how much, given that the hearing was held before President Bush had released his proposed budget.

And in an exchange with Rep. John Dingell (D-Mich.), von Eschenbach commended the FDA Science Board for its work on the report, but disagreed with the notion that FDA’s scientific base is weak. “It’s not that it’s bad,” he said. “It’s at a level of excellence that needs to continue to improve, and continue to expand.”

Since then, the Administration released a budget proposal that gives a 2.9% increase in appropriations (we wrote about that here), and von Eschenbach started to become a little more vocal about what it will take in monetary resources to get the agency back on track.

That should come as welcome news for the biopharma industry. Simply put, an underfunded, overworked agency is bad for drug sponsors. As we reported in The RPM Report this month, inadequate resources in FDA’s drug center resulted in a decision to prioritize the implementation of new drug safety standards ahead of product reviews.

Drug sponsors should hope FDA continues on its recovery path. FDA and von Eschenbach have achieved the first step; in the typical 12-step recovery program, the second step is believing that a higher power can restore sanity. Perhaps that's where Congress comes in.

Making Friends for FDA

If you can’t find friends, create them: that appears to be the strategy at the embattled Food & Drug Administration.

FDA Commissioner Andrew von Eschenbach is clearly feeling more isolated in Washington and is in need of vocal supporters. Asked at a recent American Enterprise Institute meeting about the impact of celebrity survival stories on the advancement of oncology drug development, he noted wistfully that getting celebrity support was easier at his previous job running the National Cancer Institute.

“Celebrities, that was my former life,” von Eschenbach said. “At NCI, we had just wonderful people who would speak on behalf of the importance of the agency. We do not have that many celebrities speaking on behalf of the FDA. In fact, we do not have very many people at all speaking on behalf of us. If you would like to sign up, we’d sure like to have you.”

But he may have a solution to getting long-term support for the agency: he wants FDA to train its own cadre of supporters—to create its own empathetic and understanding constituency.

Von Eschenbach has begun featuring the establishment of an FDA-led, two-year fellowship program as one of his top initiatives before leaving the agency. He has highlighted the program in speeches to AEI and the Food & Drug Law Institute annual meeting (March 26).

The goal of the program is to train each year about 1,000 individuals near the starts of their careers in a credentialed program on the duties and skill sets necessary to support FDA decisions.

FDA would hope to be able to entice about 200 of each graduating group to stay on for careers within the agency. The other 800 would go out into academia and industry with a better understanding and empathy for FDA’s regulatory tasks. That group would represent a growing base of people who would be pre-trained to accept and understand FDA’s regulatory duties.

As the commissioner explains it, the people who get the fellowship training and go on to careers outside the agency will be the “sons and daughters of FDA, intimately knowledgeable of, and aware of, FDA policies and practices and also having an opportunity of communication and rapport with those within the agency.”

They will create a growing constituency for the agency that will help mitigate some of the sharp criticism of the agency’s regulatory activities. Von Eschenbach has been talking about the possibility of training a new cadre of FDA regulatory science specialists for over a year, but the recent discussions describe the programs as being beyond the conceptual stage and into the stage where FDA is talking with potential outside groups to take on parts of the training.

The fellowship program will be launched within the next six months, he told AEI. FDA has been talking with the Reagan-Udall Foundation about running the program. An FDA spokesperson says that the foundation is looking at the agency’s request that it take on management of the fellowship program.

The Reagan-Udall Foundation was chartered under the FDA Amendments Act, headed by former FDA Commissioner Mark McClellan and is the subject of funding controversy on Capitol Hill (see here). It is one of two high priority projects that the current FDA management is pushing in the waning days of authority that could establish long-lasting commitments by FDA to entities run by former commissioner McClellan. The other project is the Sentinel post-marketing surveillance system.

Von Eschenbach told FDLI that the foundation is actually further along on the project and has accepted the challenge to make the fellowship project work. “One specific initiative that the foundation has committed to, and agreed to take on as one of its first efforts,” von Eschenbach told the FDLI annual meeting, “is to support the creation and implementation of an FDA credentialed fellowship program.”

FDLI, which represents the food and drug bar, has also been in contact with FDA to partner on part of the fellowship training. Von Eschenbach said he would like to continue discussions with FDLI “about the important role that you could play in creating modules for the fellowship program” on regulatory law and policy.

Von Eschenbach sees the fellowship program as a key component of a strategy to address the daunting challenge of adding new staff (a goal of 700 hires this year) and replacing its aging workforce (30% of the existing workforce qualifies for retirement). Training an outside cadre of FDA experts can be dangerous. The agency’s advisory committees have in effect trained a number of academics in the nature of FDA decisions over the past thirty years and emboldened some to act outside the agency as surrogates for FDA. But with so few seemingly loyal allies and friends, it is easy to see why an FDA commissioner would find the appeal of training a new constituency for the agency.

FDA's Janet Woodcock: "Change Agent"

FDA Commissioner Andrew von Eschenbach expressed rare public irritability last week at the American Enterprise Institute.

What brought an edge to the voice of the usually unflappable, on-message commissioner? He bristled at the suggestion that the re-appointment of Janet Woodcock to head of the Center for Drug Evaluation & Research represents an attempt to rebuild the old ways of running the agency’s drug regulatory operations.

“I do not see her going back to CDER as business as usual,” von Eschenbach shot back in response to a question from a reporter during a Q&A session. She “is going back as a very, very strong change agent, and we have mapped and discussed many of those changes that she is embarking upon.”

Just because she has a long tenure in FDA management and is can be termed an “insider”, the commissioner said, “does not in any way, shape or form mean that she is not a change agent.”

For those that know the commissioner well, von Eschenbach’s sharp response came as a bit of a surprise. He generally maintains an unflappable demeanor and absorbs immense criticism for the agency and his management team without flinching. His restraint, in fact, is probably one of the factors in the constant beating on the agency in the media and on Capitol Hill.

So why get so irked about questions about the Woodcock appointment?

One answer is that von Eschenbach is worried that the staff within FDA is misinterpreting the appointment.

He says, in fact, that he has been “emphatic” within FDA in explaining his view of an active role for Woodcock at CDER. “The CDER that Dr. Woodcock will create for tomorrow is nothing like the CDER that she left,” he told the AEI forum.

Woodcock offers “understanding of the historical perspective as well as the external realities that are now impacting upon the agency,” the commissioner says (see here). She is “absolutely, the most extraordinarily gifted and talented person to lead” change at CDER, the commissioner told AEI.

Another reason for von Eschenbach’s pique is the lack of understanding from the outside world to the importance that he is putting on his end-of-term appointments at the agency. At this point on the down slope of his tenure at FDA, von Eschenbach appears to be viewing his recruitments and appointments to on-going agency management as one of his key lasting legacies for the agency.

The Woodcock appointment is “not the only appointment that has occurred and will occur at FDA; there will be others,” he declared. We have pointed out elsewhere the signs of stress and management holes within CDER (see here). FDA has a lot of mid-level and senior management positions to fill that will determine the character and focus of the agency through the next topside transition in early 2009.

Von Eschenbach stressed the need to “look at it in the totality of the kind of changes that are occurring both in staffing and in organizational structure and in the programs that we are implementing. In the totality of that, you will see the transformation that we are attempting to achieve.”

From the view of a lasting transformation, the Woodcock appointment is very savvy. She has identified herself in a court deposition as being a Democrat by political affiliation, but has clearly bought into one of the goals of the Bush Administration for FDA: to make the agency aware of changes that it can make to improve the drug development process–lumped for short-hand purposes under the sobriquet of the “Critical Path Initiative.”

By moving Woodcock off the commissioner’s staff to a line management position, von Eschenbach also opens up the possibility of recruiting someone for that deputy commissioner, chief medical officer position. If he can find someone to accept that position who has the credentials and political neutrality to survive a changeover of administrations, von Eschenbach may have a bigger role in shaping the post-election FDA.

Ex-FDA Commissioner Mark McClellan pointed out the key role for the chief medical office in a separate presentation at the AEI meeting. This is the job that was highlighted by the Institute of Medicine drug safety committee that reviewed and suggested structural changes needed at FDA in 2006. The position appeared to be designed for Woodcock, but now offers von Eschenbach a chance to find someone (probably from academia) who can try to survive the post-election changes.

McClellan told AEI that the deputy commissioner position could be a key slot for determining policy in the future. “The way you get the most done in the agency is to create a framework that enables people to get together and understand the weight of the scientific issues and get some scientific momentum behind the concepts and directions in which you want to take the agency,” McClellan said.

“Maybe the deputy commissioner for science at the agency…could bring together center directors and make sure that this gets built in consistently to what is going on in the agency.” McClellan said that driving policy at FDA takes a very hands-on consensus-building approach. It is like being a university president, he said. It cannot be achieved by “top-down directives.”

Instead, the management requires convincing “many people that are knowledgeable and pride themselves on being up-to-date on at least their particular area of expertise.” The commissioner cannot be expected to manage that process personally, McClellan suggested. The commissioner will have to rely on the next tier appointments–positions that von Eschenbach now has a chance to fill.

There is at least one other possibility why the commissioner reacted strongly at the AEI meeting: the question hit an exposed nerve. He senses that Woodcock will be challenged by FDA’s critics as a lame-duck appointment who will not have a significant impact.

And that view of FDA exists among knowledgeable people watching the agency. Former FDA Commissioner David Kessler was also at the AEI meeting. He sat silently, and unacknowledged, at the back of the room during the first day when von Eschenbach spoke. But on the second day, he quite pointedly spoke out from the dais about the state of leadership at the agency.

“I am interested in who is responsible for the leadership” on policy issues at FDA, Kessler declared. From practical experience, he suggested that the line operating heads at the agency cannot take time to deal with overall policy. “The center divisions have a lot on their plates,” he noted.

That leaves the challenge for guiding policy directly on the shoulders of the commissioner and his top staff. When does the commissioner's office get involved, Kessler asked. “Who is in charge on these broader policy questions? They are complex, they need to be driven. It is not just the day-to-day that you are dealing with.”

Maybe that is why von Eschenbach dropped his calm exterior for a moment. He knows that he is viewed as letting the agency float through a critical period. He is trying to assemble the right team for another FDA commissioner in the future, to try to influence a period even less under his control. That is a tricky and thankless task–one where a little anger is understandable.

Venturing to Washington I: The Satanic Verses

We ventured down to Washington for the FDA/CMS Summit and while our RPM Report colleagues will undoubtedly share their own thoughts over the next few days, this auslander wants to set down a few of his own.

In perhaps the most entertaining of talks, Regulator-without-Portfolio and Cleveland Clinic’s cardiovascular boss Steve Nissen blasted the FDA leadership for soulless toadying to industry. He started at the top with Andrew von Eschenbach – damned as a close Bush friend (admittedly, from our point of view, hardly a recommendation) and a “urologist” (an apparent reference to some religio-medical schema that blesses the cardiovascular as kosher and condemns the urological as treif).

He was even rougher with Scott Gottlieb, who, disguised as a regulator, apparently secretly serves the Dark Lord. The sign of his sin: pre-FDA, he wrote a newsletter on biotech stocks. That the Satanist Gottlieb no longer ran the newsletter; that as an FDA employee he couldn’t invest in those stocks; that having written about biotechs might actually have helpfully informed a more realistic policy toward the companies who actually create the products on which FDA passes judgment, Nissen did not consider – or at least did not mention.

But parallel Nissenian logic would shackle Alan Greenspan to the economic consulting hell out of which he crept to run the Fed while Robert Rubin would have been stuck arb’ing at Goldman Sachs rather than shaping and running Clintonomics – and few would have said that either man had behaved, once in government, as the corporate lackey he was clearly trained to become.

Don’t get us wrong. We’re as disgusted as most Beltway outsiders by the industry/regulator revolving door, and we nearly joined an atheist chorale when Bush allowed his Zealots (taking a break from bashing stem cell research) to reach into the FDA and, pun intended, neuter Plan B.

But Gottlieb – whose politics we ourselves continue to endeavor to change – was in our view exactly what the Agency needed, helping Mark McClellan open it up, even if just a crack, to the possibilities of adaptive trial design; making the social science of risk communication into a reality in a group which doesn’t much believe in anything but FDA-defined hard science; and—weirdly, given the Secret Industry Program he’s been charged by Nissen with promoting—trying to get some guidelines around conflicts of interest on advisory committees.

And while we can’t say that we regularly carouse with the FDA’s senior careerists, we’ve certainly never heard them bash Gottlieb for trying to impose some right-wing agenda on them. [Disclaimer alert: Scott is a friend of ours and was once very nearly a Windhover employee …which must make us second-order Satanites?]

There is also this odd fact: the Mafia which, the accusation goes, ran/runs FDA for the benefit of Republicans and Big Pharma, approved a mere trickle of new products while wrapping lots of existing ones with new warnings and restrictions. Were these Mammonites merely incompetent at serving their Master?

EPO’s Future Back in FDA’s Hands

FDA Commissioner von Eschenbach: Whose Side is He On?

That sigh of relief you heard on Tuesday came from Amgen and Johnson & Johnson, when an FDA advisory committee declined to recommend significant changes in the labeling for EPO products in renal failure patients. As a commenter put it in response to our preview of the meeting, “history didn’t repeat itself.”

Probably just as important for the companies was the tone of the meeting. It was a tough meeting—any advisory committee focusing on safety concerns with your biggest products is going to be tough—but in general FDA officials avoided making inflammatory comments or otherwise suggesting that they are going to somehow make life even tougher for the anemia therapy sponsors.

After the meeting, a bunch of Wall Street analysts did something they haven’t done in a long time: they raised their forecasts for 2008 revenues from Aranesp, Epogen and Procrit, and Amgen’s stock responded accordingly.

So is the worst over?

Well, that depends. After the meeting, FDA officials said they plan to finalize the new labeling for the EPO therapies in a matter of weeks. The new labeling will address use of the drugs both in the renal failure/dialysis setting and in oncology.

And right now at least, the oncology setting is where the action is. Amgen, J&J and the oncology profession are waging an all fronts campaign to reverse the restrictive coverage policy put in place by the Centers for Medicare & Medicaid Services in that setting.

A key point of contention is whether CMS’ policy contradicts the FDA-approved labeling for the drugs. (The RPM Report has just published its latest coverage of that issue online. Not a subscriber? You can read the story for free by registering for a 10-day trial here.)

The argument that CMS is restricting access to FDA-approved uses of EPO clearly resonates politically. ASCO’s point about the conflict between CMS’ policy and the EPO label was cited in a “sense of the Senate” resolution urging reconsideration of the coverage decision.

So when FDA issues final labeling plenty of people will be paying close attention. The sponsors hope that FDA will reinforce their view that CMS’ treatment model is ridiculous—in particular, by repudiating the ceiling that CMS has set on hemoglobin levels for chemo patients. If that is how the final labeling reads, the pressure on CMS to reconsider its policy is sure to intensify.
Of course, there is another possibility: FDA could back up CMS instead.

FDA is not likely to insist on labeling that requires treatment exactly along the lines proposed by CMS, but FDA could try to tweak the labeling so that it more clearly states that treatment should maintain hemoglobin levels at the lowest level to prevent transfusions.

Or the agency could support CMS less formally, simply by stating publicly that the coverage policy is consistent with FDA approved labeling. FDA Commissioner Andrew von Eschenbach is an oncologist by training, the former head of the National Cancer Institute, and a prostate cancer survivor. With the political pressure on CMS ratcheting up, the Medicare agency is surely rooting for some show support from the commissioner of FDA.

But will they get it?

So far, there has been nothing. An FDA spokesperson says she is unaware of any plans for the agency or the commissioner to weigh in on the coverage policy, saying that falls outside the agency’s “central mandate to review drugs for safety and efficacy.”

The head of FDA’s Office of Oncology, Richard Pazdur, participated in the September 11 advisory committee review of EPO use in renal failure, but he did not use that forum to make any comments about the CMS coverage policy.

But stay tuned. The September 11 advisory committee review is definitely not the last word on EPO.

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.