FDA Commish To Employees: Keep Quiet or Else!

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

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

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

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

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

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

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

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

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

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).

The Long Campaign for FDA Commissioner (Part 2)

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

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

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

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

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

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

So who will the next FDA commissioner be?

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

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

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

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.”

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.