Regulators and Cost Watchdogs Getting Too Close, says EMEA's Lonngren

The European regulatory agency, EMEA, and Europe's various cost-effectiveness watchdogs are brushing up a little too close for comfort, according to Thomas Lonngren, EMEA's executive director. "The decision points for approval [of a medicine] and its health technology assessment [in individual European countries] are getting very close," he observed during a media workshop in London yesterday.

That in itself isn't the problem--it's simply a reflection of governments' and payers' increasing rigor in testing new drugs' cost-effectiveness before they dish out too much money for them. The problem, Lonngren continued, is that some health technology assessment agencies (HTAs) give scientific advice, "and so do we. And we'll have a big problem in drug development if there's too much different scientific advice going around," particularly as it's increasingly given at about the same time in a drug's development path.

The UK's NICE and Sweden's HTA both provide advice to companies on what kind of clinical data they need to provide in order for a green light. At least for NICE, it's a relatively recent additional activity, providing some welcome on-the-side income. Speaking to The IN VIVO Blog back in December 2007, NICE CEO Andrew Dillon argued: “Regulators charge extra for early consultations with companies,” he says, “so why not us? It’s what everyone wants.”

Now sure, companies want to know what kind of data they need to secure both an approval in the first place, and reimbursement. One's no good without the other. But "we need some agreement [with HTAs] so that industry doesn't find itself doing one development program for EMEA, and another 27 for the various member-state HTAs," Lonngren told The IN VIVO Blog.

He's gunning for harmonization of both sides' requirements, with the goal of an integrated drug development process that meets the needs of both regulators and payors.

This isn't pie-in-the-sky, at least according to EMEA. "We could possibly get consensus on the assessment of relative efficacy [of a drug] in the scientific and clinical setting," argues Hans-Georg Eichler, EMEA's senior medical officer. His point is that the cost element can be added later onto an agreed assessment of a drug's medical value, which may include impact on quality of life, for instance. (No one, Eichler included, sees standardization of HTA methodologies across Europe as likely to happen soon, though the hurdles are more political than scientific, according to EMEA execs.)

Some kind of harmonization between EMEA and HTA agencies' clinical guideline standards seems logical, though, given that HTA bodies are already banging on EMEA's door for more detailed information about its decision-making processes as a result of converging timelines. "They [the HTAs] need information [sooner], and they get that from our decision. But they're saying they need more insights [into our processes] in order to make their judgments about value," says Lonngren.

The HTA agencies (or at least some of them; they're not a coherent unit across Europe, although they have created an informal network) want more color on the various steps in EMEA's decision-making process, such as the first list of questions sent by the CHMP (the actual EMEA committee which assess drug applications) to the sponsor, the sponsor's reply, the assessment of those replies, and the weighting/significance attributed by the regulators to the various elements of a product's benefit/risk profile.

Fortunately, those demands tie in with EMEA's own drive to increase transparency--something that others including the media could benefit from too. And the work's on track, according to Patrick Le Courtois, EMEA's head of pre-authorization evaluations for human medicines. "We'll be liaising with various HTA agencies," he says, and are working to improve our EPAR (the European Public Assessment Report published for every drug that's approved, which sets out the scientific grounds for the approval, plus an SPC and labeling and packaging requirements for the product).

Whether HTA agencies will play ball remains to be seen (we'll be asking NICE's Andrew Dillon at our forthcoming Pharmaceutical Strategic Alliances conference--to which you may register here). Without their cooperation, Lonngren's concern over duplicate or conflicting advice increasing the cost and time for drug development will remain. But where EMEA is a politically neutral, executive beast, HTA agencies are, whether they admit it or not, steeped in national politics. That always puts a break on consensus-reaching.

image by flickrer athousandwordsormore used under a creative commons license

Almirall Jumpstarts COPD Hopeful Aclidinium

In a bid to resurrect investors'--and perhaps potential European partners'--interest in its beleaguered COPD drug aclidinium (branded as Eklira), Almirall announced this week that it plans to file in Europe early in 2010, almost two years earlier than expected after disappointing Phase III data last year forced a re-think.

When Spain's largest pharmaceutical firm listed 30% of its share capital back in 2007, mouths were watering at the growth story it represented: here was a mid-sized group (2008 sales: €900 million) with a potential €2 billion drug in its pipeline that could double or treble the company's size overnight.

The drug was aclidinium, a long-acting muscarinic agonist in the same class as Pfizer/Boehringer Ingelheim's Spiriva. And it had a super-duper, easy-to-use device to go with it--better than Spiriva's. Unfortunately, Phase III results showed far lower efficacy than expected and fell short on two critical secondary end-points (quality of life, time to exacerbation).

The stock fell 40%, and continued downwards to a low of about €5 in October that year. Having ridden the 'exciting newcomer' wave in the public markets for a while, Almirall came splashing down. Phase III would have to be re-done, the company said, setting aclidinium back two years in a competitive, Big Pharma-dominated marketplace.

So why the change of heart, in Europe, anyway? Apparently because of two small but significant trials, one looking at onset-of-action (vs Spiriva), and the other at exercise endurance (vs placebo). The studies involved only 115 and 181 patients respectively--small fry compared to the 1600 or more patients treated in the Phase III studies.

But Almirall reckons these trials might just be enough to build a satisfactory submission to the authorities for once-daily use. "The exercise limitation study is a big deal," asserted Prof. Paul Jones from London's St. George's Hospital in the UK on a conference call to discuss the new plans, "because tiotropium [Spiriva] didn't show a clinically worthwhile response from day one, but only a slow improvement over the six-weeks of its study," he said. (Almirall's exercise study didn't compare aclidinium and Spiriva head-to-head.)

Now granted, secondary end-points such as these are important in Europe, perhaps more so than in the US. But an approval--certainly in one cycle--is still probably a long-shot. Sure, Almirall's original Phase III trials met their primary end-points (improvement in lung function vs placebo), but they met them with far-from-flying colors. For FDA, this was a non-approvable package, full stop (and Almirall and US partner Forest Labs haven't altered their expected US filing date of late 2011/early 2012).

Safety and tolerability might have been great, but efficacy was missing, at least with a once-daily dose--which is why the partners are now running a study using twice-daily dosing vs placebo in the US. What's more, European regulators like head-to-head studies, which Almirall doesn't have (apart from the small secondary ones).

Still, "they've got nothing to lose," comments one analyst. "I suspect they may have to top-up the submission with additional data," the analyst continues--probably from the US study--"but this way at least they get the process going." Not a bad idea, given that Novartis' once-daily LABA indacaterol has shown promising Phase III data this year.

And perhaps Almirall's bullish news will trigger some interest among potential European partners for the drug, for which the hunt's still on. (With a smaller drug, Almirall might be stepping up its own commercial participation, however; even before the disappointing Phase III data, the company told IN VIVO it would like to at least participate in the key five markets.)

Indeed, this surprise move hasn't changed analysts' sales forecasts for the drug--most still sit at about $200 million in Europe, a fraction of the multi-billion dollar figures of yesteryear. Nor will it alter the fact that aclidinium isn't going to push Spiriva off its post. Far from it; with lesser efficacy "it will be the second choice to Spiriva, there's no way round that," says the analyst.

But Almirall's not Pfizer, so a $200 million 'niche' drug would still be very useful--if far from transforming.

image from flickr user .:sandman used under a creative commons license

Financings of the Fortnight: PIPEing Hot Returns?

The deal that Norwegian biotech Algeta signed with Bayer last week for its Phase III Alpharadin bone metastases candidate sent its shares soaring. The stock spiked to NOK83, closing the day on an all-time high of NOK56.

The investors in Algeta's February 2009 private placement have certainly achieved the venture-like return that VCs who invest in public biotechs aim for. That financing, led by Abingworth, was priced at NOK11 per share and brought Algeta NOK245 (about $35mm) in development capital.

If you're keeping score, that's more than a 5x return in about six months. Not too shabby!

We wrote back in April 2009 in IN VIVO that private investors looking for bargains in a downtrodden market could emerge as an important source of capital for cash-starved public biotechs, but cautioned that few companies--Algeta and its ilk, firms with late stage assets ready for partnering or about to hit a significant clinical or regulatory hurdle--would attract big PIPE dollars.

So how's our prediction holding up? The other two companies we profiled post-PIPE are doing quite well, though haven't had 500% gains like Algeta. Micromet is up more than 75% since raising the September 2008 PIPE that brought in $40mm through the sale of shares/warrants at $4.25; Cadence is up more than 50% since it sold $87mm in shares/warrants at $7.13 in February 2009.

But it appears that we were right in suggesting that VCs wouldn't pile into public biotechs en masse. According to data we crunched for September's Valuation Watch column in Start-Up, in 2006 and 2007 private placements largely kept pace with follow-on public offerings as a source of capital for public biotechs. Even though numbers were down substantially across the board, this held true in 2008. But so far this year, FOPO cash is more than double cash raised from private placements. FOPO totals are looking like they'll return to 2007 levels, but private placements, not so much.

There are plenty of reasons for this trend (that is if it is a trend at all, it may be a fluke). VC fundraising hasn't exactly been easy--sure some firms have plenty of money to spend on public biotech investments but others need to conserve dry powder to keep their existing portfolio companies afloat; FOPO financings have surged, as we noted in August; and even VCs with cash earmarked for the public markets have set high bars for the quality of their investments--regardless of fire-sale prices.

Speaking of quality, it's time for ...


Gloucester Pharmaceuticals: Following successful fund raises by Acetylon and Constellation recently, another venture-backed company working in the field of epigenetics has raised cash. And Gloucester Pharmaceuticals has a lot of things to be happy about. On August 25 it closed a $29 million Series D financing (according to the Form D, it’s raised $20.3 million so far). Joined by existing shareholders, Novo AS led the round, which brings the total invested in the firm to $100 million. Days after announcing the financing, Gloucester was boosted by more good news--the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted almost unanimously (10 in favor, 1 abstentation) to recommend approval of the company’s HDAC inhibitor Istodax (romidepsin; FK228) for cutaneous T-cell lymphoma without the requirement for a randomized controlled trial. The news was surprising, given that the day before it ruled on Istodax, ODAC voted that randomized controlled trials in elderly patients with AML, feasible or not, would be required for Clolar and Onrigin (from Genzyme and Vion, respectively). As the only candidate in Gloucester’s pipeline, there’s a lot riding on the outcome of Istodax’s NDA (PDUFA date is November 12) plus results from upcoming studies of romidepsin in peripheral T-cell lymphoma. Gloucester has been developing the candidate since 2004 (a year after it was founded), when it licensed exclusive worldwide rights from Fujisawa, which was getting out of the cancer area just prior to completing its merger with Yamanouchi.--Amanda Micklus

Novelos Therapeutics: It looks like a win-win situation for Novelos Therapeutics and Purdue Pharma. The two entered into a private placement agreement on August 26 that makes Novelos a few million dollars richer, possibly giving it some breathing room financially beyond the end of this year, and provides Purdue a substantial stake in another biotech company. Purdue has initially bought 5.3 million Novelos common shares for $0.66 (a pretty good discount of 20% based on the share price ten days prior to the announcement of the financing) for total proceeds of $3.5 million. Purdue also received warrants to buy 1.8 million more shares for the same price, and could purchase another $5.5 million in common stock if additional authorized shares are available. The extra money improves Novelos’ cash position (it had $4.5 million in cash and equivalents at the end of Q2), which could change dramatically depending on the outcome of a single pivotal Phase III trial for lead compound NOV002 in advanced non-small cell lung cancer. Results are expected early next year. Through its Mundipharma affiliate, Purdue holds European and Asian rights to the candidate under a February deal, and at the same time the current financing was announced, it worked out an agreement to negotiate a license in the US, Canada, Mexico, and Latin America. Based on our raw calculations, Purdue’s stake in Novelos is now approximately 38%, including the equity that Purdue bought--200 Series E preferred shares that convert into 15 million common--as part of the February alliance. Purdue looks to be seeking out investments in early-stage companies outside of its traditional focus on pain meds. Novelos is the second biotech Purdue has made a significant investment in since its breakthrough collaboration with Infinity last year, a deal that also focused on cancer drug development.--Amanda Micklus

arGEN-X: Forbion Capital Partners and Life Sciences Partners have led a Eur9.5 million Series A for the Dutch antibody platform play arGEN-X, demonstrating again that there is no sating VC appetites for large-molecule platform start-ups. KBC Private Equity, BioGeneration Ventures and founding investors Erasmus MC Biomedical Fund and Thuja Healthcare Capital also chipped in. arGEN-X boasts a handful of ex-Ablynx executives at the helm (led by CEO Tim Van Hauwermeiren and CSO Prof. Hans de Haard, PhD) which is fitting since the company is, like its compatriot, developing a platform based on camelid antibodies. One big difference? arGEN-X's Simple Antibody engine creates full sized mAbs, not single domains like Ablynx's Nanobody platform. A description of arGEN-X's platform, which the company says yields unencumbered mabs 'with best in class human germline homology,' is here. It remains to be seen whether Big Pharma appetites for mAb platform acquisitions will continue to match VCs' enthusiasm for funding such companies, but we doubt we've seen the last novel mAb platform start-up.--CM

image by flickr user copyrider used under a creative commons license

Jim Greenwood: The Movie

The Biotechnology Industry's Organization's policy briefing went very smoothly on Sept. 9 except for one question. BIO was "pleased" with how the follow-on biologics debate was turning out, and didn't even appear upset about a potential $2.3 billion annual excise tax that might be imposed as part of healthcare reform. But the association was flummoxed when asked about the Supreme Court case on campaign finance law that the Justices were rehearing the same day. Centered on a conservative advocacy group's ability to distribute the documentary "Hillary: The Movie," the case could have broad implications for how businesses can spend money to influence elections.

Did BIO have a position on how corporations should be treated in this First Amendment context? "I'll tell you as soon as I'm advised by counsel," BIO President Jim Greenwood said. He tilted his head away from the microphone and towards General Counsel Tom DiLenge, who had hopped up from his seat and was now crouching behind Greenwood's chair. After the pair whispered in the classic consolatory pose, BIO's new chairman, Stephan Sherwin, said, "I just felt like I was on C-SPAN."

"I'm told we don't have a position on this issue, and we don't," Greenwood said. "We have a political action committee and use it the way that political action committees are used, but we have not seen a need to take a position on that issue." Sherwin, the CEO of Cell Genesys, also demurred on the question.

"The best thing that corporate executives can do is contribute to the BIO PAC," Greenwood quickly added, demonstrating the fund-raising acumen that helped him serve six terms in Congress.

Top Facet Investor's Big Sell-Off

When we wrote earlier this week about Facet Biotech's rejection of Biogen Idec's $356 million hostile bid, we mentioned that Facet's top investor, Baupost Group of Boston, held about 18% of the company as of June 30.

It doesn't anymore. In a regulatory filing Wednesday, Sept. 9, Baupost said it sold about 25% of its Facet stake, or about 1.2 million shares, to drop its ownership to 14%. It made the sale Friday, Sept. 4, the same day Biogen went public with its takeover bid of $14.50 a share. The public bid was 50 cents a share lower, Biogen said, than an earlier private bid it made in late August.

Baupost's new ownership percentage is noteworthy because it drops the investment firm, founded in the early 1980s by Seth Klarman, below the 15% threshold that Facet drew as the trigger for the poison pill plan it adopted in response to Biogen's hostile intentions.

Announced Tuesday, Facet officials said at first that the plan grandfathered in Baupost. Not so. Because Baupost's sell-off occurred on Sept. 4, it predated the adoption of the poison pill plan by three days. The firm is not grandfathered in, after all, according to a Facet attorney.

Klarman did not respond Wednesday to a call for comment. Then again, his words don't come cheaply, though here's a free videoconferenced talk he gave to the business-school students at the University of Western Ontario. (Goooooo, Mustangs!) Klarman is the author of the 1991 book Margin of Safety: Risk-Averse Value Investing Strategies for the Thoughtful Investor, which is out of print but available on Ebay starting at $800, last time we checked.

The IN VIVO Blog Podcast: Elan and Biogen's Day in Court

Welcome to the latest installment of the IVB Podcast. Today we're putting on our LA Law costumes and analyzing everyone's favorite courtroom drama.

With deadlines looming, there are several unanswered questions swirling around the complicated Biogen Idec-Elan-Johnson & Johnson kerfuffle. Thanks to a federal judge's surprise ruling last week in a Manhattan court, Elan has until Sept. 26 to fix the breach of contract the judge said it committed in its Tysabri licensing relationship.

If it doesn't fix the breach, Elan could lose its half of Tysabri, which stands to hit $1B in sales this year. But in fixing the breach, Elan must also negotiate with J&J, which as part of its sprawling $1.5 billion deal for Elan stock and Alzheimer's assets, thought it had a side deal with Elan to help buy out Biogen's half of Tysabri (an event triggered if and when Biogen is ever bought out).

Confused yet? Hang on: This side deal, though, turned out to be the source of the breach, the judge said -- by giving J&J the option to help with the financing, Elan had assigned its Tysabri rights without its partner Biogen's consent. And if J&J doesn't like the way Elan is reworking the side deal, it can walk away from the entire Elan/Alzheimer's deal on Sept. 15.

Follow along as Alex Lash and Brenda Sandburg walk us through this mess, by clicking the button below. Hey know what? You can access the podcast via iTunes also.

Is There a Drug Lag? Polls NOW Open

Apologies to all who tried to vote in our poll on the so-called "drug lag" between the US and FDA. The link in our email yesterday was incorrect. Fraud? Ballot box stuffing? No. Typo? Yes.

Here is the correct link to the poll: http://answers.polldaddy.com/poll/1955904/

And here is the original post (with the poll embedded).

Sangamo Surprise: Tail Wags Dog

When we checked news on health care stocks and saw that Sangamo Biosciences was up following a press release announcement of a paper pointing to the potential use of its zinc finger nuclease technology to modify human stem cells, we did a double take. It took us a little while to settle back into work mode after the long Labor Day weekend. But we could have sworn we had discussed this paper with colleagues already, several weeks ago.

Indeed, the paper's official release date was August 13, when Nature Biotechnology announced the study's advance online publication (AOP). And the study was accompanied by a press release from the Whitehead Institute at MIT, where the work was done by Rudy Jaenisch’s group. So why did Wall Street only react to it yesterday?

Because Sangamo only put out its PR on the “news” Tuesday morning, when the print edition of NBT came out. According to Sangamo, whose scientists were among the paper's coauthors (but not correspondents with the actual journal editors), the company was first alerted to the AOP the day before it went live. The company was also caught off guard because the paper had only been accepted two days before that, on August 10 – a remarkable and unexpected turnaround time.

With such short notice and summer schedules – and maybe doldrums too – they saw no reason to scramble. (And frankly, it was our view at the time that the paper, although good science and relevant to Sangamo’s platform partner Sigma-Aldrich, was not of any immediate import to drug developers.) That said, the AOP was picked up in a timely fashion by various blogs and press release cut-and-paste services.

Apparently, however, the publication escaped the attention of movers and shakers on the Street until today. There was no blip in price or volume in Sangamo’s stock in mid-August. But on Tuesday, shares rose on the opening and closed up almost 8% on 3x the average volume.

Given the timing of the original AOP, we're not accusing Sangamo of manufacturing or manipulating news. Nor was this a huge movement for a small-cap stock. Surely some trader types would make sophisticated arguments about the need to understand how momentum impels the movement of stocks more than the strength of the underlying news itself. Maybe it was just a handful of traders moving in and out.

But why did it take a company PR to trigger the attention? Aren’t analysts supposed to work hard and dig deep, and that’s why they are paid the big bucks? Or is it that common for the tail to wag the dog? We’re just sayin’.

While You Were Changing the Guard

Oh, hi. Welcome back to the working world. Biiiiiiiiiig stretch. Time to dust the cobwebs off your keyboards and trade tales of BBQ mishaps. All set? Here we go. When's Columbus Day?

Not long after Roche announced a new, post-Genentech-privatization management crew it is shaking things up again. Bill Burns is to step down as head of pharma; he may wind up on the Roche board of directors; and head of diagnostics Jurgen Schwietzer and R&D chief Jonathan Knowles are also hanging it up. As if that weren't enough, short-term Genentech CEO Pascal Soriot is jumping up to COO of pharma and getting replaced by Genentecher Ian Clark as CEO there (Richard Scheller stays put as head of Genentech research and early dev). Jean-Jacques Garaud is also getting a promotion, to head of Roche pharma research and early development, and he and Dan Zabrowski (head of pharma partnering) are getting seats on Roche's enlarged executive committee with Scheller et al.).

There are more changes, and you can get the details at the press release linked above. Also: Bloomberg's take is here, Reuters' is here.

Meanwhile, while you reacquaint yourselves with things like desks and full-sized computers ...

• Roche's soon-to-retire pharma chief Burns went on CNBC over the long-weekend to discuss Tamiflu as part of the Big Pharma's press briefing about the product and swine flu. "We're at a calmer moment," and not in a major pandemic, he said. Feel better, gang?
  
• Pfizer's efforts in oncology as a microcosm of the broader everyone-into-cancer-development trend in pharma: 'profit but little progress' says TheAge/NYTimes.
  
• Scientists in Wales and France ID three new Alzheimer's markers, though none are as predictive as APOE4: MIT's Technology Review's take here.
  
• Robert Reich reviews "The Heart of Power" by Harvard prof/Obama advisor David Blumenthal and Brown prof James A Morone. The book, written prior to Obama's push for reform, examines how various presidents have tackled the idea of universal health care.
• Prasugrel earns a limited recommendation, for high-risk PCI patients only, from the UK's NICE. (h/t pharmagossip)
• Ipsen has licensed to Debiopharm its CDC25 inhibitor, and retained an option to take the cancer drug candidate back after Phase II trials. Hey this strings-attached approach to in-licensing worked OK for Speedel, right?
• Have you taken our poll on the existence of the so-called Drug Lag?
  
• The Phillies are doing their best to keep it interesting, losing four straight in Houston. (Insert "we have a problem" joke here ... Uuuughh.)

image from flickr user kol tregaskes used under a creative commons license.

"Lagging Indicators:" Does Europe Approve Drugs Faster Than The US?

We heard a phrase we haven't heard in a long time this week: "Drug Lag."

Merck EVP Worldwide Regulatory Affairs & Product Safety Peter Honig used the phrase during his introductory remarks to an Institute of Medicine workshop on drug safety, intended as part of a series of updates on IoM's past review of the US Food & Drug Administration's safety regulation.

Drug lag is a term straight out of the 1980s, when the pharmaceutical industry argued that excessive conservatism by FDA meant plenty of lifesaving drugs came to market first in Europe, while US patients suffered or died waiting for the agency to act. We've since seen analyses claiming the whole notion of a "drug lag" was hooey, but that didn't matter: the perception, as Honig noted, was a key motivating factor in helping push through the Prescription Drug User Fee Act, which undeniably led to a rapid increase in the number of new drugs first marketed in the US.

Indeed, a generation of pharmaceutical industry managers grew up in a world where the industry's largest market (the US) was also its fastest growing market, and the one most likely to grant market entry first. Quite a trifecta.

Well, the US is still the largest pharmaceutical market in the world, but it sure isn't the fastest growing. And Honig, at least, thinks it is also showing signs of lagging behind Europe in market entry. The Merck exec didn't press his case hard, but he did prompt a response from FDA's top new drug review manager, John Jenkins (pictured above).

There are really "two issues people are raising" about new drug reviews, Jenkins noted. One is the undeniable fact that there are some delays associated with new processes and procedures, like the Risk Evaluation & Mitigation Strategies or "safety first" initiative. Jenkins acknowledges that FDA has "taken on a huge process burden" and "the money has not followed at the same pace as the new responsibilities." So some "lag" may be inevitable, at least until resources and habits catch up with the new workflow.

But, Jenkins continued, that isn't really what people worry about. They worry about whether "FDA is becoming more conservative."

And that, Jenkins said, is very hard to quantify, because "we have lagging indicators." Economists, he noted, prefer to focus on leading indicators, but the only was to tell what is happening with approvals is to look at statistics for various application cohorts, and the data inevitably trail months or even years behind the calendar.

So "the most recent data we have is from fiscal 2008, and you really can't see any kind of fall-off or change that is dramatic for first cycle approvals of new molecular entities."

But, to Jenkins' credit, he doesn't just drop the issue there. "It is hard to quantify if my division directors or my office directors are affected by the drug safety debate that has been raging in this country for the last five or six years." The issue "has calmed down a bit recently," Jenkins said, but "have they been impacted?" Are "they less likely to approve a drug today with the same data package that they might have been five years ago?"

"It is impossible to make that assessment because you just can't answer those questions," Jenkins says. "What you have to look at is the data over time to see if you see any trends."

Jenkins noted that he presented an analysis of recent drug approvals last year (at, we might add, our very own FDA/CMS Summit for Biopharma Executives in Washington DC). That data showed seven drugs approved in Europe at that time, but not in the US, and only two in the US but not Europe. (Read our coverage here.) But that data is "now close to a year old. We've been looking at it again, but we haven't reported any more recent analyses." (We hope that will change this Dec. 3, when Jenkins opens the fifth annual FDA/CMS Summit.)

But even a clear indication that there are more drugs approved in Europe first may not be persuasive. "There are a handful of drugs approved in Europe that we haven't approved," Jenkins said. "We'd be happy to argue in public why we didn't approve them, but we can't always do that."

One of those drugs, Sanofi Aventis' weight loss agent Accomplia, was ultimately withdrawn in Europe for safety reasons. So, Jenkins said, "Only time will tell: are we being too conservative and depriving patients of needed drugs, or are they being too aggressive and going to run into the same safey buzz saw that we blew through in the 2000 decade."

Time will tell indeed, but we are impatient here, so why don't you all tell us instead: respond to our poll and let us know what you think. Is there a drug lag? And if there is, is it because FDA is too conservative or EMEA is too reckless? Look for the results next week. (If you are reading via email, click here to take the poll.)