Monday, September 5, 2011


I have been invited to participate in a meeting later in September  where the FDA, congressional staffers, the pharmaceutical industry large and small, clinicians and finally, the press will gather. The purpose of the meeting is to expose for congressional staffers the special nature of antibiotics and the challenges currently faced by society in bringing needed new antibiotics from the research laboratory to patients and clinicians.  I need to explain that I have been invited not as a participant from industry, not as a clinician or scientist, but as a member of the press.  I don’t know if I should be grateful to have been invited at all (I am!) or if I should be insulted.  What do you think?

The draft agenda I have seen suggests that there will first be a discussion of antibiotics and areas of current urgent medical needs for new products.  This will be followed by a discussion of the regulatory challenges for antibiotics followed by a discussion of the economic challenges for companies and academics wanting to bring new products to market. Of course, there is nothing in this meeting that has not been discussed previously ad nauseum. There have been multiple reviews from IDSA and others summarizing the dire threat of rising antibiotic resistance both in our hospitals and our communities.   The clinical needs are clear and are becoming more urgent with time, especially for treatment of Gram-negative infections.

The regulatory situation, especially in the US, has been the subject of countless FDA advisory committee meetings, IDSA-FDA workshops, and has been discussed publicly in a variety of other forums.   There have been many appearances on Capitol Hill by infectious diseases clinicians, the IDSA and industry discussing the medical need, regulatory environment and economics of antibiotic development.  So, while I welcome the opportunity for another shot on goal with Congress, I don’t understand what it is that they don’t get. Are they not listening?  Do they not care?  If it’s the latter, let’s not waste more time. If it’s the former, what makes us think they will listen now – especially in the current political and economic climate?

I recently had a discussion with a colleague on incentives in regard to this upcoming meeting.  I have been contemplating once again the various economic incentives that could be used to encourage industry to get back in the antibiotics game.  But you know what? Effective incentives for industry will never be passed in the current political and economic environment.  Lets face it. But, even though I find that disappointing, I disagree with my colleagues who are prioritizing incentives over regulatory reform.  As I have stated on multiple occasions, without a clear regulatory path for antibiotic development in the US, no amount of money will suffice to attract industry back into the business.

As I see the ongoing evolution of the state of antibiotic research and development within industry, we have probably reached bottom.  The number of large pharmaceutical companies exiting the area will now be balanced by those getting back in to one extent or the other.  I see the imminent departure of Novartis balanced by the arrival of Sanofi-Aventis and the toe-dipping exercise of Bayer with Trius.

We should learn from the companies who are getting back into the business, Sanofi-Aventis and Bayer.  I believe that both, but most certainly Bayer, are targeting Asia.  Why?  There is a clear regulatory path forward and a growing market – especially for antibiotics. The clear regulatory path, so far, is coming from Europe where one can leverage a European approval to win approval in most emerging economy countries. The US has a clear regulatory path for skin infections – period.  The pathway for respiratory infections no longer exists.  The FDA has promised new guidelines for intraabdominal infections and for urinary tract infection. This does nothing but increase fear and uncertainty in industry given what has already happened with respiratory infections.  So the US market is being wiped off the map by our lack of a clear and feasible regulatory path for key antibiotic indications. Companies see this clearly but they also see the rising market opportunities in the merging economies especially in Asia-Pacific (see figure - Antibiotic sales in dollars last 5 years 2006-10).  This leaves us n a situation where needed new antibiotics will be developed and will be available for patients and physicians in China and India but not for Americans here in the US.

So – here’s my suggestion for Congress.  It won’t cost taxpayers a dime.  Ask the FDA in public hearings why we do not have feasible regulatory paths for the development of needed new antibiotics and why India is a more attractive places to develop and sell antibiotics than the US. In my view, at this point in time, this is the only practical starting point in the real world.  Of course my caveat is that Congress doesn’t really know what it’s doing either . . .

Now – my conundrum.  I want to participate in the meeting I mentioned earlier.  But as a member of the press, I probably can’t get up and make statements.  I will actually have to ask questions to make my points.  I’m not sure I know how to do that.  So – any suggestions are much appreciated.


  1. Of course, I can answer my own question, right? If Congress does have hearings on the FDA they will find that they themselves are partly responsible for our current dilemma. After the Ketek scandal of 2006, they threatened the FDA with hearings over the use of non-inferiority trials to approve antibiotics. This resulted directly in the current FDA stance.

  2. So David, the best way to ask a question with editorial gravitas is to cite expert sources' opinions. Perhaps you could cite a friend's take on the situation and then ask them to respond. Or you could cite a study in a journal that backs up your point. You just have to keep your expertise out of the equation, because if you appear to know too much, they'll know you're not a journalist!

    Anyway, let me know how it goes. And if it's being webcast anywhere, send me a link.

    Good luck,

    Lee Howard
    The Day

  3. David,
    These hearings could be related to the GAIN Act. There is a real chance that this act could pass, even in this legislative atmosphere. Though the bill may not meet certain standards for companies in the field, it is a step in the right direction.
    I agree with you about the opportunity in emerging markets. It is ironic that the regulatory path in these markets is more clear than in the US and Europe. Good luck

  4. As I have stated previously, I believe still believe that the GAIN act, which relies on extended exclusivity for the new antibiotic, will not push the NPV enough to entice most large pharmaceutical companies who are, after all, the most important partners for universities and biotech since they have (for now) the biggest pockets. A number of economists and large companies (e.g. GSK) agree with me.

  5. I will go out on a limb and say that the large pharmaceutical company analysis on opportunity in antiinfectives discounts that market primarily because of the competing opportunities. I think most people would agree with me that antibiotic development is a niche that has permanently moved away from big pharma. The question then becomes how to sustain and develop the niche. The GAIN Act is of significance to smaller and midsize companies (Cubist and smaller). Reviving interest from big pharma is not the answer for antibiotics.

  6. If you don't revive interest for large pharma - what will happen to today's biotechs that have not had the Cubist experience? Their options for funding phase III will be limited to public markets and to BARDA (if they can cover special agent pathogens). We need large companies as partners for biotech and for academia and to beef up our research effort. We need more Cubists in the world. GAIN won't get us there.