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Optimizing Industrial Involvement with Medical Countermeasure Development

February 25, 2010

The wonderful folks over at the Homeland Security Digital Library recently passed along a draft report out of the National Biodefense Science Board (NBSB) (pdf download link) about how to fix the slow process for developing medical countermeasures (MCM). After the painfully slow development and distribution of H1N1 influenza vaccine that we all lived through last year, this type of effort should be of primary importance. Unfortunately, the recommendations are similar to most other public health preparedness policy documents and will probably be just as unacted upon as the rest of them.

That doesn’t mean it’s not important, though! Here’s the skinny:

While describing the need for medical countermeasures, the NBSB makes what I think this is a crucial point which really highlights the differences between typical emergency management efforts and public health emergencies. While emergency management is (rightfully so) considered a local matter up until the point where the local jurisdiction can no longer handle it, public health emergencies immediately call in the heavy guns:

Individual States cannot take responsibility for protecting their residents until the Federal Government provides the tools – in the form of MCM – to do so.

I think this is such an important point because of the nation’s experience this past fall. No matter what great work the locals and states did, they couldn’t give what the public demanded without the federal government. Ditto case counts (during the spring and summer). The federal government is a critical partner in response, and if they – as might happen – give timeframes for delivery that are off by several weeks – for example – that might cause local and state response measures to fail. (Hey feds! I know it wasn’t your fault!)

The rest of the section is a bit depressing. The authors list all of the things intended to help fix this problem (e.g., BARDA, the EUAs, “the animal rule,” the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), etc.), but still find the execution lacking. Simply stated:

More needs to be done. National security interests make it the responsibility of the U.S. Government to do more, faster, to provide for our biological defenses.

One of the most oft repeated reasons for the slowness of MCM development, as voiced by those interviewed by NBSB is that the process is fragmented, with confusing approaches at multiple points.  Many representatives similarly consider contracting with the US Government to be slow, unwieldy, expensive and opaque. I write about these concerns every time we talk about national-level efforts toward some goal of public health preparedness – no coordination. The most famous of these is the effort at biosurveillance.

The NBSB report then goes on to note that this effort is similar to other herculean tasks that that US has undertaken and believes that by finding a comparable situation, we might be guided as to how best to proceed with advancing the process (I’m totally digging the out-of-the-box thinking!). The Manhattan Project didn’t really work, due to the singular goal they focused on. The difficulties that the Navy faced in the 1930’s when looking to design aircraft carriers isn’t perfect because of the promise of consistent acquisition by the government. They did find one scenario that seemed to fit, though, that of the building of space exploration vehicles:

In the 1960s NASA contracted with the commercial aerospace sector for lift vehicles and spacecraft. America’s space program benefited from innovative contracting authorities (e.g., Other Transaction Authority, OTA) to enable greater collaboration than typically is permitted by the Federal Acquisition Regulations (FAR). But “boom” and “bust” cycles since the 1960s led to the loss of uniquely trained workers, and slowed the pace of space exploration. MCM developers have also experienced boom and bust cycles, where starts and stops in congressional appropriations and White House support led to the lay-off of scarce scientific and engineering talent.

Furthermore, monies that had been appropriated to Project BioShield have been re-appropriated more than once away from MCM development. For profit companies simply cannot invest in the process without being assured that there will be a market for their goods.

The rectify the situation, the NBSB makes eight recommendations. Some are very simplistic (and yet, still not implemented!), while others are quite ingenious and would go a long way towards speeding things up:

  1. To harness the national industrial base, the U.S. Congress and the Executive Branch must provide adequate, consistent funding.
  2. The U.S. Government must accelerate the pace of MCM development and acquisition, and optimize distribution methods.
  3. The U.S. Government must centralize its leadership for MCM development, procurement and approval.
  4. The U.S. Government must demonstrate long-term commitment to its industry collaborators.
  5. The U.S. Government must create, sustain and enhance innovative partnerships with private industry.
  6. The U.S. Government should expand MCM markets to include state and local first-responders and allied governments.
  7. The U.S. Government must do a better job of preparing for anticipatable emergencies.
  8. Various departments and agencies of the U.S. Government must act in concert to ensure success.

I’m a big fan of #1, #3 and #7, though I think they’re all particularly good. Download the report here to see the paragraph explanations the NBSB has included for each recommendation.

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