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.

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.

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.

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.