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2011 Public Health Emergency Medical Countermeasures Enterprise Stakeholders Workshop

January 10, 2011
Washington, DC

Thank you for that warm welcome. It’s good to be here.

Before I begin, I want to say a few words about the tragic shooting this weekend in Arizona.

There is no place in our country for these senseless acts of violence and no words that can fully express the sadness we feel. Like all Americans, my thoughts and prayers are with Representative Giffords, the other victims, and their families.

Saturday’s attack was especially tragic because it occurred at an event where people had gathered for a conversation about how to build a better community for themselves and their neighbors.

The kind of attack that tries to shut down those conversations affects us all, and it has been heartening to see all Americans put aside their differences and condemn what happened together.

Today, I know we all join the rest of America in praying for a full recovery for the victims who are still with us and for peace and comfort for the families of those who are not.

The events of this weekend were a reminder that we live in a dangerous world and how important it is that we be ready to respond to any threat at any time.

At HHS, we have a great team working towards that goal, starting with Dr. Lurie. Over the last two years, she and her team have played a key role in almost all of our Department’s public health activities. And those efforts have benefited enormously from her vision, leadership and experience.

Dr. Lurie is part of a terrific leadership group that also includes Dr. Francis Collins and Dr. Anthony Fauci at NIH, Dr. Margaret Hamburg at FDA, Dr. Tom Frieden and Dr. Anne Schuchat at the CDC, Dr. Robin Robinson with BARDA, and Dr. Bruce Gellin at the National Vaccine Program.

The list goes on. There are countless dedicated men and women across the Department of Health and Human Services, and many are here today, who work tirelessly to make sure the American people are prepared and protected in the event of any public health crisis.

But we know we cannot do it alone. To keep Americans safe, we need everyone to step up – the federal government, state and local governments, private industry, first responders, health care providers, academia, community leaders and ultimately, the public.

That’s why today’s workshop is so important. It is an opportunity not only to share lessons learned but also to look ahead, plan and prepare together. So I want to begin by thanking all of you for your individual participation today and for your commitment to keeping the American people safe tomorrow.

I was sworn in as Secretary just as we were recognizing the first wave of the H1N1 flu pandemic, a crisis that put every aspect of our public health system to the test. Less than an hour after I became Secretary, I was taken to the White House Situation Room to be briefed.

The Department of Health and Human Services didn’t waste any time. Building on the groundwork laid at workshops like this in past years, we mobilized the world’s top scientists and worked closely with outside groups and other federal agencies.

Thanks to coordinated steps among all the HHS agencies, we established a strong, sophisticated, and transparent apparatus to quickly evaluate the new vaccine’s safety, with very reassuring results – a confirmation of the strong safety record we’ve consistently seen for flu vaccines including the H1N1 vaccine.

And thanks to the hard work of thousands of people at the global, national, state and local levels, we developed and distributed the vaccine in record time – avoiding the worst predictions for flu season.

Everyone here today and so many others worked incredibly hard over many, many years so that when we actually faced a crisis, the systems were in place and we were ready and prepared to respond.

Now, last year’s efforts are shaping this year’s response. The flu season has officially begun with high rates of disease already evident in southeastern states and New York City.

This year it’s a mix of strains, but they are all well-matched to the vaccine.

And even though vaccine uptake is better than it has historically been, we are still not where we need to be. It’s not too late. We all need to continue to encourage everyone 6 months or older to get vaccinated.

Of course, H1N1 also taught us important lessons about our broader medical countermeasures enterprise.

The next public health crisis could come in the form of a dirty bomb set off in a subway car or a naturally-occurring superbug that can resist all treatments.

But whatever it is, we know that our ability to respond will depend on successful public-private communication and collaboration.

It will depend on an informed and engaged public. It will depend on our ability to work effectively across the government and to execute a national strategy on the local level. And it may well depend on our ability to make a countermeasure against something we have never seen before, much faster than we have in the past.

That’s why we are here.

Fortunately, we have a new road map to help show us the way forward.

As you know, this summer our department unveiled its comprehensive analysis of the nation’s medical countermeasure enterprise. This first-of-its kind review confirmed that the pipeline we rely on to provide those critical countermeasures – diagnostics, vaccines, antivirals, antibiotics – is full of leaks, choke points, and dead ends.

And it provided key recommendations to help us start building a 21st-century medical countermeasure enterprise that is modern, flexible, and equipped to respond quickly and effectively to any threats that arise.

In the coming years, the Department of Health and Human Services will direct nearly $2 billion in preparedness funds toward that end, with the goal of establishing a solid base of discovery and evaluation and an agile infrastructure for manufacturing and distribution.

I know Dr. Hamburg will describe some of the specific steps we’ll take going forward including the agency’s new Regulatory Science Initiative, a strategic framework to modernize how we evaluate and regulate product development.

And you will hear from others about some of the other ways we are working together to do things in a fundamentally different way.

You will also hear from Andy Weber at the Department of Defense about how our interagency partners are adapting to the need for a more integrated national approach to preparedness and response.

I am sure many of these goals and priorities sound familiar. They came out of extensive dialogue with many of you here today and stakeholders across the country.

When President Obama first asked our Department to conduct this review, we knew our first step would be to speak directly with the experts and leaders confronting our public health challenges every day in labs, boardrooms, and city halls.

The Institute of Medicine hosted a 2-day Forum on Public Health Preparedness and Drug Development. The National Association of County and City Health Officials brought together a similar summit with its members and partners.

We conducted in depth interviews with opinion leaders and representatives of pharmaceutical and biotechnology industries as well as their investors. And we drew feedback from the President’s Council of Advisors on Science and Technology and the National Biodefense Science Board.

Since rolling out the review and its recommendations this summer, the dialogue has not stopped. We are in frequent contact with state officials and first responders about their changing needs especially in tough budget times.

We have hosted roundtables in Denver, Philadelphia, and Orlando with end-users like first responders and health care providers. More are planned for 2011. And the Institute of Medicine has created a new Committee on Pre-positioned Medical Countermeasures for the Public.

I am also excited to hear the individual ideas and strategies that come out of the group discussions you have later today.

This approach aligns with a broader National Health Security Strategy which the administration released in 2009 to coordinate all our work to prepare for and protect against all catastrophic health events, both naturally-occurring and man-made.

The Strategy emphasizes the importance of public and private sectors working together, striving to share a common vision and use finite resources to protect the American public.

Let me repeat: government cannot do this alone. We are counting on your experience and expertise to help make these goals a reality. We are counting on your partnership.

It is in this spirit that the Department’s Biomedical Advanced Research and Development Authority (BARDA) is working to establish one or more new Centers of Innovation for Advanced Development and Manufacturing.

Despite our tireless efforts during the H1N1 influenza pandemic and success at avoiding the worst predictions, we still did not have the capacity or flexibility to produce enough vaccine in a timely manner.

These new centers would serve as key platforms where flexible manufacturing can take place.

They will have the potential to offer a dependable and robust domestic source of vaccines and other countermeasures for pandemic influenza, unknown pathogen outbreaks, and other evolving public health priorities.

And they will be established as public-private partnerships to serve as a resource so that small biotech companies with big ideas can get the regulatory, technical, and manufacturing know-how they need to demonstrate their product’s potential and bring it to market.

We also understand that small businesses, our principal partner in developing many of these medical countermeasures, may not have access to the capital and business expertise they need to get potentially important ideas off the ground.

That’s why we’re exploring the concept of a Strategic Investor whose mission would be to find and nurture those organizations that have the greatest chance of making good on the public's early investment.

At the same time and in the same spirit, we are also creating what we call the Concept Acceleration Program at the NIH, to ensure that discoveries with great potential do not die on the vine.

Special teams will help guide concepts through early stage development with partner agencies, academic researchers, biotechnology and pharmaceutical companies.

I am confident that programs like these will begin to pay dividends quickly. As investors and scientists get the resources they need to take an idea to the next level, they will attract additional support and bring renewed attention to promising projects.

But this also represents a powerful investment in our future. It’s what Jonas Salk meant when he said our greatest responsibility is “to be good ancestors.”

If we want to be prepared for the threats we will face as a nation, ten, 20, even 50 years from now, we must begin preparing and investing today.

That philosophy also runs through the new health care law, the Affordable Care Act. Although it is not often referred to this way, the bill is one of the strongest public health bills our nation has ever seen.

It makes a historic commitment to our health care workforce and infrastructure, building the kind of foundation that is essential to any response to crises that might occur, next week, next year, or next decade.

In the last nine months, nearly $3 billion has been granted under the Affordable Care Act to community health centers to make health care more accessible to underserved communities.

And the new law has invested $250 million that, combined with funding in the Recovery Act, will contribute to the training, development and placement of 16,000 new primary care providers by 2015.

The Affordable Care Act also continues the important investment in scientific research creating jobs and helping us stay competitive as a nation.

The Treasury Department has announced recipients of the $1 billion therapeutic discovery grant and tax credit program, helping small businesses that are developing new and cost-saving therapies for patients suffering from serious diseases.

In the months and years ahead we will continue to move forward, implementing the new law effectively, improving it where we can, and with your help, making sure more American people get access to the care and protection they need.

I want to thank you again for joining us today, and for being part of this important effort.

Our public health defenses are only as strong as their weakest link.

Only by working together as full partners can we strengthen our entire, end-to-end response -- from detecting threats early to dispensing medical countermeasures to the public -- from the scientist in the lab to the nurse in a clinic.

Thank you.