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Countermeasures Review Rollout

Washington, DC
August 19, 2010

Good morning. Thanks for joining us today.

Our greatest responsibility in government is keeping the American people safe. To uphold that responsibility, we have always maintained a powerful military that can guard against conventional threats. But increasingly, the range of dangers we face is widening to include biological, chemical, nuclear, and radiological hazards.

Today, we don’t know where our next public health crisis will come from. It could be a dirty bomb set off in a subway car. It could be a naturally-occurring superbug that can resist all treatments. It could be a biological weapon we’ve never seen before, assembled from the building blocks of life by a terrorist in a lab.

It was with this increasingly crowded landscape of natural and manmade threats in mind that we released our country’s first-ever National Health Security Strategy last December.

The principle at the heart of that strategy is that our public health response is only as strong as its weakest link. So, using it as a guide, we’ve worked to upgrade our entire end-to-end response, from how we assess and identify threats to how we distribute and administer products to counter those threats in cities and towns across the country.

But as we studied this landscape, it became clear that there was one area where we needed to put a special focus: medical countermeasures.

Medical countermeasures are vaccines, antivirals, antibiotics, diagnostics, and medical equipment. In a public health crisis, they’re our most direct, and often our most effective, defense.

To reach our national stockpiles, most countermeasures travel the same path. They begin as a discovery in a lab. Then the discovery gets translated into a useful product. Next that product gets tested for safety and effectiveness. And then someone manufactures it.

If this process works well, there’s a steady output of new countermeasures targeted at our biggest potential threats. But the closer we looked at our countermeasure pipeline, the more leaks, choke points, and dead ends we saw.

In an age of new threats, we weren’t generating enough new products. In a business where delays cost lives, we couldn’t develop and manufacture countermeasures fast enough. And at a moment when the greatest danger we face may be a virus we’ve never seen before, like the one that causes SARS, we didn’t have enough flexibility to adapt to unforeseen threats.

So we had three choices. We could cross our fingers and hope the worst never happened. We could pump more money into a leaking pipeline. Or we could roll up our sleeves, take a hard look at what was going wrong, and start building the 21st-century countermeasure enterprise we need to keep Americans safe from 21st-century threats.

For us, the choice was clear.

Which is why, last December, with the encouragement and strong support of President Obama, I called for an unprecedented review of our entire medical countermeasures enterprise.

Led by our department’s Assistant Secretary for Preparedness and Response, Dr. Nicole Lurie, that review drew on dozens of conversations with state and local health departments, industry groups, venture capital experts, academics, scientists, and biotech developers around the country.

As we conducted these conversations, common themes emerged. We needed to focus more on children’s unique needs. We needed to work more closely with our partners across government including the Department of Defense.

But most of all, we needed to move toward the report’s vision of a nation with, quote “the nimble, flexible capacity to produce medical countermeasures rapidly in the face of any attack or threat, known or unknown, including a novel, previously unrecognized, naturally occurring emerging infectious disease.”

Today, we are releasing the report that sums up those findings. You can read it at our website, hhs.gov.

But we are not here this morning just to talk about how we can do better. We are moving forward with a plan that will strengthen our countermeasures pipeline at several key points.

Guided by this review, we’ve identified five areas where we believe we can act now to make big improvements in our public health defenses.

First, we’re going to strengthen regulatory science at the FDA.

One of the hardest parts about getting a product from the test tube to our national stockpile is making sure it’s safe and effective and meets manufacturing standards. It’s even harder for drugs that target a rare or emerging disease that’s poorly understood.

But for too long, we’ve underinvested in the tools, models, methods and knowledge needed for making these assessments – what’s collectively known as regulatory science. Because of this underinvestment, we’re often testing and producing cutting-edge products using science that’s decades-old.

So we’re going to give our world-class FDA scientists the resources they need to create clear regulatory pathways, analyze promising new discoveries faster, and help identify and solve scientific problems as they occur. And we’re also going to reach out to product developers early in the process so they know what to expect.

The second area we’ll focus on is developing flexible manufacturing. Right now, too many of our countermeasure factories are filled with big equipment that’s designed to produce one product over and over again. That works well for seasonal flu vaccine. But it leaves us vulnerable when the countermeasure we need most may be one we don’t use regularly or haven’t invented yet.

That’s why in the next few weeks, we’ll announce a solicitation for new Centers of Innovation for Advanced Development and Manufacturing – facilities that will work to develop new flexible manufacturing platforms while giving us a dependable domestic source of surge capacity for flu vaccine so we won’t have to rely on foreign producers as we did during the H1N1 crisis.

And these Centers will also serve as a resource where small biotech companies with big ideas can get the regulatory and manufacturing knowledge they need to bring their products to market.

The third area we’re moving on is nurturing discoveries in their earliest stages. Today, it’s common for a scientist to make a discovery without realizing it could be turned into a useful countermeasure. Or they may see its potential, but not know what to do next.

That’s why we’re going to use a wide array of NIH resources to identify and nurture these promising discoveries, including creating new “Sherpa” teams to guide them through the development process.

As we conducted this review, we looked at the full range of public health threats. But after dealing with H1N1 – and with H5N1, the avian flu, looming – we naturally put a special focus on our flu response.

That’s why our fourth priority is upgrading the way we manufacture flu vaccine – from modernizing potency and sterility testing to speeding up the production of vaccine seed strains. These are the same steps recommended in a new report from the President’s Council of Advisors on Science and Technology that you’ll hear about in a few moments, and they’ll ensure we’re better prepared for flu seasons to come.

Finally, the fifth area we’ll explore is a strategic investment fund for new countermeasure technologies. Right now, there’s little incentive for private companies to produce medical countermeasures for rare conditions like the Ebola virus or exposure to non-medical radiation. Yet in the event of an Ebola outbreak or a nuclear explosion, these countermeasures would be critical.

A strategic investor could support those companies with ideas that have little hope of making huge profits but big potential to improve our public health preparedness.

As this review went on, we also looked beyond our labs and factories at what we could do differently right here in Washington.

We found that our contracting processes were often too rigid, for example. We realized we needed to do a better job talking to the private sector throughout the product development process rather than just when we want to license a product. And we saw that we needed better coordination, not just within our department, but across government.

We incorporated some of these lessons into our response to the H1N1 pandemic last year, and we’re going to keep working to make sure we’re doing our part to strengthen our response.

There is an old saying in sports that victories are won on the practice field when no one’s watching. In the same way, how successfully we respond to tomorrow’s public health crisis when the spotlight is on will be determined by how hard we work behind the scenes today to build a 21st-century countermeasures enterprise that can respond quickly and effectively to any threat.

That’s why in the coming years, we will direct nearly $2 billion in preparedness funds to these five key areas.

And although our official countermeasure review concludes today, our work to strengthen our public health preparedness will never end. We know that our enemies are constantly probing for weaknesses. Every year, new threats emerge and old ones evolve to become resistant to our medicines.

That’s why we will continue to look for ways to build – not just a stronger countermeasures enterprise with a solid base of discovery, a clear regulatory pathway, and agile manufacturing – but also a stronger public health response all the way from disease surveillance to administering countermeasures to people in our cities and towns.

Today, we’re taking a big step toward building a safer America. Tomorrow, the next step begins.