FDAAA Delays: Hurry Up and Wait

If you are going to be late, you might as well be late on everything.

That appears to be the mantra of the Food & Drug Administration these days. After alerting industry earlier this year to the fact that it would start missing approval deadlines, FDA is now warning members of Congress that it will miss implementation deadlines under the FDA Amendments Act.

As reported in "The Pink Sheet" this week, the first anniversary of FDAAA's passage on September 27 comes with it a spate of provisions with deadlines for implementation.

We don't claim to have any insight as to which ones won't happen as planned, but the dozen or so deadlines include one that should be of special interest to the drug industry: the start of the priority review tropical disease voucher system. Others include a report to Congress on best practices for communicating the risk-benefit balance to the public and the development of a post-marketing drug safety website.

So far, we're hearing that Congressional members aren't too concerned about the missed deadlines. Which makes sense, given that FDA hasn't exactly had an on-time record for FDAAA over the past year. For example, the agency is already quite late on a report to Congress on the number of vacancies and disclosures related to advisory committees; it was due February 1.

We find the whole situation a bit ironic, since FDA has been telling sponsors that part of the reason it is missing user fee deadlines is because of all the work it is doing under FDAAA. The news that the agency will miss those deadlines as well seems to illustrate just how severly understaffed FDA actually is.

FDA is staffing up--of the 1,163 or so new employees that the agency will hire before the end of the fiscal year, 1,005 are already on board, and 158 are due to report in by September 28, according to FDA. Another 160 candidates have accepted offers but are still undergoing clearance and related security processes.

But even with all those new hires, FDA still has vacancies: The recent Food & Drug Law Institute advertising and promotions meeting, for example, sounded at times like a government job fair, with officials making a pitch for working at FDA from the podium.

Given the scope of the Amendments Act, perhaps missing deadlines was inevitable. For sponsors, whether or not FDA sends a report to Congress won't make or break a balance sheet. But it is just another reminder of just how stretched the agency is--and how long it will take before agency operations are back to normal.

Domain, No More

In what's become a familiar storyline over the past five years, a general partner--this time Robert More--has parted with Domain Associates.

More has joined Frazier Healthcare Ventures becoming a full partner in the Seattle-based firm's $600 million fund. More leaves Domain after eight years as general partner.

More is the third general partner to leave the venerable firm since 2004. Arthur Klausner was the first, leaving the firm shortly after it raised its $464 million fund. He went on to join Pappas Ventures, which is in the middle of raising a new fund. The following year, Olav Bergheim, another Domain general partner, left the firm to start Fjord Ventures. Both left the firm on good terms, saying their personal investment preferrences differed from Domain's.

In an industry where stability is highly valued, the departure of two general partners in two years raised some questions about the firm's succession plans, particularly as some of the firm's founding partners approached an age at which others might consider retirement. More, who first joined the firm as a Kaufmann fellow, appeared to be part of the long-term succession plans, but things played out differently.

More says his joining Frazier presented a new opportunity. "From my perspective, I'd been there for a long time," More said in an interview yesterday. "I really enjoyed the interaction with the partners. Jim Blair is someone I admire. But I think it's the right time [to move on] and I've known Frazier for some time."

More is jumping from on top-tier firm to another. But VCs rarely break from a general partnership merely to try something different. When asked why he'd leave a firm like Domain, More acknowledged that he'd had some "philosophical differences" with his former firm. He declined to give further detail, directing any additional questions to Domain. Partners Jim Blair and Brian Dovey couldn't be reached for comment.

Despite any differences, More says he leaves Domain on good terms, saying he'll likely co-invest with his former partners when possible. He'll also retain some of his board seats on Domain companies. At Frazier, More will work from the firm's Silicon Valley office, which is moving from Palo Alto to Menlo Park, investing in both biopharmaceutical and medical device companies. More has invested from Domain's San Diego area office for the past three years. He'll continue to live in the San Diego area.

Managing Partner Alan Frazier likewise says the hiring won't impact his firm's positive relationship with Domain. "We're pleased to get him and pleased this is supported by his friends at Domain," Frazier says. Frazier says the firm wasn't searching for a new partner when it began discussions with More. He said couldn't pass up the opportunity to bring aboard More, who counts among his wins Novacardia Inc., ESP Pharma Inc., Esprit Pharma Inc., Intralase Inc. and Proxima Therapeutics Inc.

To be sure, Domain will continue to be regarded as a top firm as it should be. But More's departure likely will raise questions about Domain's succession plans. Four of the firm's eight partners have been with the firm for at least two decades, including three--Blair, Jesse Treu and Chief Financial Officer Kathleen K. Schoemaker--who have been with the firm since its start in 1985. Dovey joined the firm in 1988.

In fairness, Domain's addition of new partners doesn't tend to draw as much ink as the departures, but the firm has added talent. Partner Eckard Weber, who you can read about here, joined in 2001. Partner Brian K. Halak made partner in 2006 after five years at the firm. Nicole Vitullo came aboard to manage the firm's public equity fund. She made partner in 2004.

Most recently, Dennis G. Podlesak became a partner in 2007 after founding and leading two successful portfolio companies, Cerexa Pharmaceuticals, and Peninsula Pharmaceuticals, which were sold to Forest Laboratories and Johnson & Johnson, respectively.

No word on whether Domain will be in the market for a new partner to replace More.

Macroeconomic Trends: When Bad News Is Bad for Your Business

Before the insightful analysis comes the unscientific poll. The fallout from the bankruptcy of Lehman Bros. and the recent sales of Bear Stearns and Merrill Lynch will have effects beyond the banking sector. How bad will it be where you work?



(Email subscribers: click here to participate in our poll.)

Is Big Pharma Ready For Minibusters?

Some things are easier said than done.

That’s the opinion of one biotech CEO commenting on claims by some large drug companies that they are moving towards smaller, more targeted drug products. While the strategy may sound good, they can’t do it, he says.

“Once you’re invested in a big model, you’re invested in it,” the biotech CEO maintains. The biotech CEO based his arguments on two key points:

1) The enormous scale of large pharmaceutical companies invested in R&D through to sales and marketing dictates they must sell large products aimed at broad patient populations.

2) The long and established blockbuster culture of large pharmaceutical companies creates an imposing hurdle to retooling business strategy to focus on smaller, niche products.

On the first point, the biotech CEO compared the total size of an average biotech company to just one product sales force of a big pharma company. On the second point, he said size impedes agility. “Big companies move slowly.”

In addition, he says a culture of assumed successorship—“my father worked there, I work there, my son will work there”—is a challenge to creative thinking and leads to complacency.

We’ve argued that the creation and implementation of FDA’s postmarket powers in the form of risk evaluation and mitigation strategies (REMS) means companies will be pushed more towards well-defined, marketable populations as a result of tighter controls. To read more, click here.

It’s not that the blockbuster drug, one with a billion dollars in annual sales, is dead, but those products will become increasingly rare and will be found in more specialty markets as opposed to primary care.

That means more products with annual sales in the $200 million to $500 million range, or minibusters.

So who is ready for the move towards more targeted, minibuster products? Well, biotech, of course.

The biotech CEO says the size and culture of biotech companies allow them to be more focused and reshape their strategies without scrapping the overall framework of their businesses. In other words, more agile and less exposed to complacency.

That leaves a conundrum for large pharmaceutical companies. It’s not enough to downsize and shed jobs, he maintains. That just reduces your size and cuts costs. The expectations from shareholders will remain the same. The question, he says, is “now what do you do?”

He highlighted blockbuster products as the great “gift” and “curse” of Big Pharma. It brings great long-term success to a company but also conditions management to overly rely on that product, focusing little attention anywhere else.

Can pharma companies make the minibuster model work? The jury is still out, and will be for quite some time. But at least one executive is skeptical.

While You Were Liquidating

A crisis in the US banking sector pushed Hurricane Ike and politics to page 2 this weekend. A selection of headlines from the NYT pretty much says it all for Wall Street: "After Frantic Day, Wall St. Banks Falter," "Jittery Road Ahead," "Stunning Fall for Main St.'s Brokerage Firm," "Banks Fear Next Move By Shorts," "Nation's Financial Industry Gripped By Fear." Lehman Bros. has filed for bankruptcy, Merrill Lynch sold out to Bank of America. Insurance giant AIG teeters on the brink. The Wall Street Journal's special coverage is here. While you were waiting for the sky to fall ...

• Prostrakan received FDA approval for Sancuso, its transdermal 5HT3 receptor antagonist for chemotherapy induced nausea and vomiting. Prostrakan will market the patch--its first drug approved for the US market--with NovaQuest (more on that innovative collaboration--and others like it--here in our 'Royalty Flush' feature from June's IN VIVO). Sancuso also won IN VIVO Blog's award for a drug name that sounds most like a CBS procedural about a disgruntled and tough (but fair) police detective. Bonus FDA News: UCB's Keppra XR also received approval, the pharma said today.
  
• Sanofi this morning extended its offer to buy the shares of Czech generics maker Zentiva that it does not already own. Nothing says 'please!' like an entire web site dedicated to the cause.
  
• Are you a French biotech? Are you lonely? Are you tired of sitting at home watching 'Allo 'Allo reruns while all the other biotechs are out with the VCs? Well, worry no more: your industry association has this friend, it's a brother of a friend really, and well, nevermind, just get started with France Biotech's Bioweb Seed Dating (remember, on the Internet, nobody knows you're une chienne).
• Bayer CEO Werner Wenning to German paper Tagesspiegel: we are not vulnerable to takeover (but of course you can't rule it out ...).
• Good news for NicOx: a second pivotal trial (study 302) for naproxcinod met its three co-primary efficacy endpoints (and its secondary endpoints as well) in patients with osteoarthritis of the knee (a third study, in osteoarthritis of the hip is due to read out later this year). Pooling results from studies 301 and 302 demonstrated a statistically significant decrease in blood pressure at the higher (750mg bid) dose as well, though the blood pressure data for 302 alone were apparently inconclusive, though "non detrimental". NicOx shares were up 13% in Paris this morning. Our 2007 story on naproxcinod and NicOx's R&D and business development plan for the drug is here.
• Biovitrum said this morning that it was acquiring the marketed biologic therapeutic products Kepivance (palifermin) and Stemgen (ancestim) and licensing exclusive worldwide rights to Kineret (anakinra) from Amgen for $110 million in cash and $20 million in Biovitrum shares plus milestones and royalties. The products generated a combined $70 million in 2007 sales.
  
• RIP David Foster Wallace.
  

image from flickr user puzzlemepuzzle used under a creative commons license.

Deals of the Week: A Little Less Conversation, A Little More Action, Please

This week was one of those weeks where so much more seemed to happen than actually did. Yes there was the rumor that Pfizer was buying Bayer (we tend to agree with Derek Lowe's thoughts on that one, the deal is on the "Edge of Reality"), the Carl and Jim Show ("Return to Sender," covered extensively by our Pink friends) and King's hostile attempt to take over Alpharma ("Don't be Cruel," see yesterday's release here and our coverage of King's original offer here), and various other rants and rumors.

Execs across the industry have been "All Shook Up" in the most compelling actual news this week, with Christine Poon retiring from Johnson & Johnson in March 2009, Ellen Strahlman leaving Pfizer to become GSK's chief medical officer and GSK CEO-runner up Chris Viehbacher taking the top slot away from Gerard Le Fur at Sanofi.

Finally we thank the dealmakers below. They didn't step on our "Blue Suede Shoes" and so they have the honor of ...

GSK/Cellzome: GSK has entered into an option agreement with Anglo-German biotech Cellzome around seven kinase inhibitor programs in the area of inflammation, the companies said on Wednesday. Though the deal generated several hyperbolic wire story headlines the guaranteed payments (about $25 million in equity purchases and cash, split undisclosed) were rather more pedestrian. More importantly, the deal has some interesting features and further underscores the externalization of R&D at GSK under new chief Andrew Witty. Cellzome is essentially becoming GSK's center of excellence in kinase drug discovery, at least in the inflammation space, Cellzome CEO Tim Edwards told IN VIVO Blog yesterday. GSK has an option to license--at clinical proof of concept or earlier--drug candidates from Cellzome's kinases programs against four identified targets (which very likely comprise the biotech's previously announced programs against mTOR, Zap-70, PI3K delta and JAK3) and an additional three further targets. Edwards noted the deal does not include Cellzome's lead PI3K gamma program for which the company hopes to file an IND in 12-18 months. Until such time as GSK opts into a project, Cellzome is footing the R&D bill. However the biotech can earn milestone payments along the way that will cover those costs, and keeps rights to programs GSK declines. "We have day-to-day control," explains Edwards. "They're sponsoring us, as it were, and as we make achievements we bring in additional dollars." Cellzome has previously inked a handful of deals around its proteomics mapping platform and has outlicensed Alzheimer's programs to J&J, but this deal is its first around its Kinobeads technology. That platform allows the firm to screen for kinase inhibitors in a "physiological setting," which Edwards claims means they can identify very selective inhibitors of individual kinases. "In oncology you can hit four or five targets," without compromising the safety/efficacy profile of a kinase inhibitor. "But that isn't OK in inflammatory disease, and the solution is to have very selective inhibitors. It's amazing how you can change a molecule in a very small way and change its selectivity profile in a profound way," he says. Optioning nearly all its programs to one partner in its chosen (and crowded) field of kinase discovery does suggest that GSK is the private firm's only potential suitor, however, significantly limiting Cellzome investors' exit options (the company has raised at least €73 million since 2000 from a variety of VCs). "Today that may be the case," says Edwards. But perhaps not for long, he says. Cellzome aims to reconfigure its screening platform for other target classes and is also diversifying out of inflammatory disease into CNS and potentially other therapeutic spaces. And then there's the PI3K gamma program. For now, Edwards is keeping the details of that program under wraps.

Tripos/Pharsight: Drug discovery informatics player Tripos said this week it was acquiring clinical-software specialist Pharsight for about $57 million ($5.50/share). That price is a 29% premium to Pharsight's 30-day average. The combined company will now provide R&D software and services from discovery through to the market, says the release. Sorry to "Forrest Gump" you, but that's all we have to say about that.

Alfama/hemoCORM: Alfama and hemoCORM, two companies pursuing the use of carbon monoxide releasing molecules (CORMs) in a variety of chronic and acute diseases, merged this week. The terms were undisclosed. We profiled each of these companies back in 2004 (see here and here). Back then we wrote: "CO is produced naturally in the body as a result of the breakdown of heme oxygenase, an enzyme involved in the recycling of iron. But CO is more than simply a useless by-product. Recent research has shown that under physiological conditions, it is also important signaling molecule with vasodilatory, anti-inflammatory and anti-apoptotic properties." Both Alfama and hemoCORM are working on metal carbonyls, one of the first types of compound identified as a potential CO-carrier. hemoCORM's initial efforts are focused on ischemic perfusion injury, while Alfama is working primarily on treatments for inflammatory and auto-immune disease. Alfama chief Nuno Arantes-Oliveira will lead the combined group.

CV Therapeutics/Menarini: This week's late-breaker see's CV Therapeutics licensing European, CIS, and certain South and Central American rights (27 countries in all) to its recently approved ranolazide (Renaxa) to Italian pharma Menarini for $70 million in upfront payments plus a potential $315 million in milestone payments and investments linked to European label extensions and sales figures. The angina treatment has been marketed in the US by CVT since January 2006; currently the company aims to secure approval in a first-line angina setting.

Amgen/potential denosumab partner: Remember when we were all "Amgen might be looking for a denosumab partner, how much would you pay for it"? And you readers were all "sorry, IVB, I'd really like to take a stab at this, but I'm washing my hair, can I get back to you"? Well, it seems absent any solid advice from you guys, Amgen CEO Kevin Sharer is now saying that a US partnership around denosumab is unlikely (though things might be different overseas). "It is very hard for me to imagine what another company would bring to us," in North America, Dow Jones reports Sharer saying at the Morgan Stanley health care conference on Tuesday. Maybe Sharer needs to watch a little Sesame Street to get those imaginative juices flowing. Let us help out: a worldwide or US partner on denosumab would not only bring Amgen a significant upfront payment, primary care expertise, and drug reps, but also a big ol' hedge against the risk that the product will be delayed or even fail. Bonus Denosumab: The Pink Sheet DAILY points out today that doctors worried about denosumab getting adequate reimbursement are asking Amgen for assurances for financial protection in the event Medicare won't cover the full cost of the drug.

New CMO Means Business For GSK

No new CEO in our industry has done more to shake up his organization than GlaxoSmithKline's Andrew Witty (except perhaps Severin Schwan of Roche with his bid for Genentech--but that's another story).

Earlier this spring he created high level positions devoted to corporate strategy and emerging markets and the formation of a new $500 million corporate venture fund. Just days after rumors concerning also-ran Chris Viehbacher's departure were confirmed comes news that Witty's lured Ellen Strahlman, MD, away from Pfizer, where she served as VP Licensing and Worldwide Business Development, to the role as GSK's chief medical officer.

As the press release announcing Strahlman's appointment helpfully points out:

"the Chief Medical Officer is the most senior physician leader of the company with primary responsibility for matters of patient safety, general medical governance, ethics and integrity, medical information, and investigation involving human subjects relating to any GSK products in development or on the market."

Which is what makes Strahlman's appointment so interesting. Yes, she's a well respected physician--an ophthalmologist by training. And since she once served as CMO and Global Head of R&D for Bausch and Lomb, so she's no stranger to the duties a CMO title brings with it. But her most recent stint at Pfizer, where she was at least partly responsible for spin-outs and outlicensing, means she comes with a business focus that's atypical of most of the industry's CMOs.

And Strahlman's background is by no means unique in the boardroom at GSK. When you look at who occupies the top spots at this pharma, a number of them have deep biz dev experience. Among them: Russell Greig, head of the new GSK Venture Fund, who was GSK's senior VP of world-wide business development before becoming president of Pharmaceuticals, International; David Redfern, the company's new strategy guru, who has held stints at GSK as SVP Corporate Strategy and Development and SVP of Northern Europe; and Moncef Slaoui, who was SVP world-wide business development for GSK before becoming chairman of the R&D program.

And that leads this IN VIVO Blogger to wonder...With so many top brass at GSK--including now the CMO--trained to look for products outside GSK's own pharm system, what's the importance of internal R&D to GSK?

It's a fair question. GSK has never shied from inking big deals to fill its late stage pipeline drought. In recent months that's meant tie-ups with Valeant for their Phase III anticonvulsant, Actelion for their Phase III insomnia drug, and Cellzome for their Kinobead technology and kinase inhibitor discovery/early development. And in attempt to spur innovation within GSK's walls, Witty announced in July a reorganization of the CEDDs into discovery performance units that will compete for internal financial resources much the way biotech start-ups vie for VC funding.

“Externalising R&D enables GSK to capture scientific diversity and balance expenditure and risk in drug development. In the future, we believe that up to 50% of GSK’s drug discovery could be sourced from outside the company,” Witty said in a press release announcing the new strategic priorities.

No one is suggesting that Witty wants to jettison GSK's internal R&D--at least for now. But the structural changes that have already been announced and this most recent appointment of Strahlman to CMO suggest that more and more business as usual at GSK will also come with an external focus.

“Standstill” Agreements Limit Potential Buyout Deals

A month ago, everyone had the same question: which Big Pharma will be the next to buy-out a biotech partner. First, Roche/Genentech. Then Bristol/ImClone. Who would be next?

So far, the answer is: no one.

It turns out that there just aren’t all that many partnership out there where a buyout is in fact an option. We looked at 12 partnerships cited by analysts and other business media as potential partner-turns-into-prey stories, and it turns out that eight of them involve contracts that prohibit one partner from making an unsolicited offer for the other. (The complete list is published in “The Pink Sheet” this week.)

We got the idea thanks to a sharp-eyed reader of the IN VIVO Blog who responded to one of our posts on Byetta. In a discussion of the disconnect between what struck us as a relatively restrained safety alert by FDA and a hyperbolic panic among Amylin investors, we wondered why Lilly doesn’t just buy out its partner if it believes Byetta is safe.

It ain’t that simple.

As we should have known (since our reader helpfully pointed to the citation in our own database), the Lilly/Amylin agreement includes a comprehensive “standstill” provision that prohibits Lilly from trying to buy its partner.

Similar provisions are included in most of the other deals we looked at.

Most, but not all. It turns out Genzyme can buy out BioMarin any time it chooses, and Genentech is free to bid on either OSI or Biogen Idec—though somehow we don’t think that is a high priority for Genentech right now. And Biogen is free to buy its Tysabri partner Elan—presuming it doesn’t mind triggering the change-in-control provisions in Elan’s Alzheimer’s partnership with Wyeth. (And change-of-control provisions, of course, are a story unto themselves though that particular provision isn't one of the industry's most onerous.)

Nor are all standstill provisions created equal. Lilly is prohibited from buying Amylin for as long as the Byetta partnership lasts—and beyond (unless, of course, Amylin decides to negate the standstill). In other cases—like Bristol/Gilead and Wyeth/Progenics—there are expiration dates that come up soon (as in, during 2009). Other partnerships (J&J/Vertex, Wyeth/Elan) also have standstills that expire—but in those cases the dates are tantalizingly undisclosed.

So if you expected a flurry of Bristol/ImClone style deals to keep you entertained this fall, think again.

Thank goodness ImClone thinks it has another bidder. Its much more fun to watch companies running in place than it is to see them standing still.

PS. Click here for a free copy of all of our coverage of Roche/Genentech...

Why Merck’s Problems are Also Your Problem

Will Vioxx never go away?

It has been four years since Merck withdrew the COX-2 inhibitor. It is a full year since Congress enacted legislation intended to “fix” the drug safety problems highlighted by Vioxx.

But Vioxx is still in the news. Now, the focus is on how the product was marketed. Academic journals, mining product liability dockets, are highlighting instances of “ghost writing” and “seeding studies” involving the product. The media gleefully piles on.

If you don’t work for Merck, you may be tempted to think none of this much matters. (Except perhaps as an occasion for schadenfreude, if the unrestrained glee of these posts is any indication.)

We’ve written before about the far reaching impact of a damaged reputation, and specifically about the implications of the blemishes on Merck’s once-stellar image as the drug company that does things the “right way.”

But Merck’s problems are not just Merck’s problems. The damage to Merck’s reputation is the whole industry’s problem.

Here’s why: Just as Vioxx was the short-hand explanation for a whole host of drug safety changes—most of which, both Merck and its harshest critics agree—had nothing whatsoever to do with the drug, now it is a short-hand for everything that people object to about industry marketing practices.

And Vioxx’ potency as a weapon against the whole industry is all the greater because it was sold by Merck.

One example came during the Food & Drug Law Institute advertising & promotion conference September 8, when Ann Witt, a former FDA ad division head who is now an advisor to Congressman Henry Waxman, discussed Waxman's opposition to a proposed guidance that would allow companies to disseminate peer-reviewed journal articles on off-label uses:

"There are many many examples, and unfortunately there are more coming to light every day, of company-manipulated data that ends up in peer reviewed reports. I’m sure we’ve all followed the somewhat distressing trail of evidence that is coming out about how Vioxx was promoted. There have now been at least four or five separate articles on the different methods that Merck used to manipulate study results."

"I--who have spent probably 20 years following drug advertising and thought I was pretty cynical about it--I found the stories about Merck personally extremely depressing. I would imagine many of you do. "

"I, like many people at FDA, always thought of Merck as sort of the gold standard in the industry, and to find that this kind of really irresponsible marketing and distortion of the scientific record was so pervasive there is truly troubling."

"I would hope that it would lead all of us to question whether substituting peer review, for FDA review and approval, is really a good way for doctors to learn about new uses of drugs."

In other words, if Merck does it, then everybody must do it.

And consider the context: Witt is citing allegations against Merck to block a guidance on off-label journal reprint distribution. That is an issue that is of far less significance to Merck than to dozens of other companies with more prominent positions in oncology, pain or other markets where off-label uses are essentially standard practice.

That is how it works. Companies that never marketed a COX-2 inhibitor have to live with mandatory post-marketing studies and Risk Evaluation & Mitigation Strategies. They may also have to live with a whole host of new marketing restrictions—whether enacted by Congress or simply created by more aggressive enforcement at FDA.

FDA's Real Risk Communication Challenge

FDA is the first to admit that it hasn’t quite figured out the best way to communicate drug risks to patients—especially how to convey emerging risk information without scaring patients away from a helpful or life-saving treatment.

But it is also clear that FDA hasn’t quite figured out how to communicate within the agency on communicating risk to patients, either.

On Friday, FDA announced a major new policy on risk communication under which it will begin alerting the public to potential safety problems with a drug or biologic at the very beginning of the post-marketing drug safety process. (Check here for our earlier take on that initiative.)

On Monday, FDA’s senior advisor on risk communication in the Office of the Commissioner, Nancy Ostrove, spoke at the Food & Drug Law Institute’s annual meeting on advertising and promotion.

Given that the title of Ostrove’s speech was “FDA’s Initiatives in Communicating Risk Information,” it appeared to be the perfect venue for discussing the new program—so much so that one might have wondered whether the agency timed the announcement to coincide with Ostrove’s FDLI presentation.

Apparently not.

After avoiding mention of the program in her opening remarks, Ostrove gave the following disclaimer before the question and answer session: “I can tell you one thing I am not going to talk about…the press release that went out on Friday concerning the FDAAA provisions on quarterly reports. I didn’t even get it until today. So I can’t talk about it.”

Given the pains that FDA took in announcing the decision—a rare embargoed media call ahead of the official announcement with Office of Drug Safety director Gerald Dal Pan and Safety Policy & Communication associate director Paul Seligman—it was surprising that Ostrove wasn’t on the call herself, or, at the very least, aware that it had taken place.

There may be good reasons for Ostrove not to have been in on that decision. But given FDA’s recent focus on risk communication (check out our coverage in The RPM Report here and here), we can’t help but wonder whether the real communication on risk needs to first take place at FDA.

image from flickr user rubatacchini used under a creative commons license