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Implementing the Recommendations of the Secretary’s Medical Countermeasure Review

Remarks as Delivered by Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
2011 Public Health Emergency Medical Countermeasures Enterprise Stakeholders Workshop
"Implementing the Recommendations of the Secretary’s Medical Countermeasure Review"
January 10, 2011

Good morning—and thank you for inviting me to speak at this important meeting. As you may know, my experience in biosecurity and public health preparedness began many years before I took the job of FDA Commissioner. So I am deeply committed to these issues—and highly invested in the discussions that will be occurring today, which I hope can foster a new level of collaboration among the public health, scientific, and industry professionals here today.

We are, after all, working toward a common and exceedingly important goal—the safety and well being of the American people. And in that spirit, I hope this meeting will help transform our words and plans into meaningful actions and the results we need.

I know that all of us are horrified and saddened today in the aftermath of the events in Arizona this past weekend. Unfortunately, we live in a world full of violence and hate. It can take many forms but always tragic…and we wish Congresswoman Giffords and the other survivors of this devastating crime all best wishes for a complete and speedy recovery…and mourn those whose lives were so senselessly taken.

Today we are talking about a very different—though not wholly unrelated—set of threats. Those posed by chemical, biological, radiological, and nuclear weapons, which have the potential to overwhelm our public health and medical capabilities—resulting in immense social, political, and economic disruption, on top of the enormous toll on life and health. And we are also concerned about naturally occurring infectious disease threats, as we know that mother nature can be a very effective terrorist.

In short, deliberate and naturally occurring biological threats threaten our nation’s well-being and security. We can still remember the impact—and the fear—that resulted from the anthrax mailings of 2001 and, more recently, the pandemic flu of 2009.

While significant progress has been made in the medical countermeasure area, our nation remains vulnerable to CBRN threats and naturally occurring infectious diseases. And we all recognize that our nation lacks many of the medical countermeasures needed to counter known threats and we lack the capacity to rapidly develop new countermeasures in the face of new threats. This is unacceptable.

But we are now poised to make critical changes. This administration has made it clear that developing the medical countermeasure capabilities we need to rapidly and effectively respond to a deliberate CBRN event—as well as naturally occurring infectious disease outbreaks—is a priority as Andy just outlined. And really, now it is more than a priority. It’s a mandate. As you know, the medical countermeasure review ordered by Secretary Sebelius was the first step in executing changes needed to answer the call.

I am here this morning to speak to you about role of the Food and Drug Administration in the process change that we are launching within the Public Health Emergency Countermeasures Enterprise. You will hear in more detail about other HHS components of this new initiative later in the program.

The Enterprise Review clearly identifies the critical role FDA plays in a successful MCM Enterprise. The Review noted that strong and dynamic FDA engagement is needed to accelerate MCM development towards approval, establish clear regulatory pathways for product innovators based on the most advanced scientific foundations available, and realize the promise of new technologies for flexible, rapidly scalable development, and manufacturing of vaccines and other MCMs.

As I see it, we have a duty to do everything in our power to facilitate and speed the development of these vital medical countermeasures. Our proactive engagement early in the medical countermeasure development process can help hasten the approval of a candidate product. And, it may also identify, as early as possible, products that may be unsuitable or not yet ready for continued development, allowing us to make strategic decisions about where to invest our limited and valuable resources.

Of course, this is a huge responsibility, and one that I take very seriously. But it is also an opportunity to build a comprehensive program that tackles the historic challenges that we face—and a chance to improve the regulatory science required to develop more effective and sophisticated countermeasures.

We learned during the 2009 pandemic that our agency can act nimbly, mobilize efficiently, and collaborate widely in a public health emergency. We learned that we can be extremely effective. But we also learned that to sustain this type of action—and to better prepare for it—we need additional manpower and resources. We need better science. And, most importantly, we learned that we need a clear, systematic approach to working with partners.

As part of the Secretary’s MCM Initiative, we have created a plan that focuses FDA efforts on real and immediate action—action that is, in fact, already underway.

Specifically, the plan has been designed to address key challenges in three different areas. I will briefly outline them for you now—and allow my colleague, Dr. Luciana Borio, to explain them in more detail later in this meeting.

First, we will enhance the regulatory review process for the highest priority medical countermeasures and related technologies. FDA will establish multidisciplinary Action Teams that will tackle the range of regulatory, scientific, and policy issues facing MCM development and approval. The teams will ensure consistent regulatory approaches and efficient implementation of best regulatory review practices.

Importantly, we will work closely and interactively with developers and government partners to define viable regulatory pathways, speeding progress toward product approval by helping to anticipate and resolve bottlenecks, and to identify and address scientific problems that may emerge as early in the development process as possible.

Second, we will advance regulatory science on behalf of MCM development. This is so important, yet it has not been the focus of adequate attention, concern, and funding…until now.

Regulatory science represents the science and tools needed to assess and evaluate a product’s safety, efficacy, quality and performance—and is vitally needed to improve countermeasure development and evaluation pathways. Strengthening regulatory science in meaningful ways must involve both strengthening our own, internal FDA scientific capacity as well as reaching out to build collaborations with industry and academic experts.

Together, we must pose and find answers to a range of really important questions. For example, in the context of emerging biological threats—both deliberate and naturally occurring—there is often limited opportunity for human clinical studies or well-tested or appropriate animal models…non-trivial problems if you need to evaluate diagnostics, drugs, and vaccines for these serious potential health concerns.

By applying regulatory science to these areas of research, we hope to develop new approaches to evaluate product efficacy; more flexible, agile approaches to product development and manufacturing; new methods to improve product stability; and new statistical approaches to assessing efficacy with limited data, among other things.

We are very serious about our MCM work. In order to succeed, we need to become even more strategic and aggressive in our partnerships with industry and academia as well as with other key government agencies, including the Department of Defense. It has been a pleasure to have the opportunity to work with people of the caliber and commitment of Andy Weber.

We want to create an environment that allows all of us to fully harness the best available science on behalf of our biosecurity efforts. And most importantly, we want to pool not just our products and resources, but our brainpower. We want to hear everyone’s ideas and bring them together to find the best possible solutions.

These regulatory science efforts will improve our ability to be both proactive and reactive: they will allow us to identify and help solve the scientific challenges that hinder medical countermeasure development and result in unacceptably long delays in getting the products we need. It will enable us to be more nimble in addressing emerging threats, and, importantly, advancements in regulatory science will also have significant implications for our work outside of medical countermeasure development, as well.

Third and finally, we will optimize our regulatory and legal framework. In both the near and long term, this will prove very valuable. We will work with HHS and other government partners to conduct an examination of the legal framework, as well as regulatory and policy approaches, toward MCM development and availability—and to assess adequacy, or improvements needed, to properly support preparedness and response.

On a separate but equally important note, we are also committed to improving the awareness of FDA’s broader workforce on issues of biosecurity and, specifically, medical countermeasures so they are all equipped to contribute to our efforts. We have launched a Medical Countermeasures Lecture Series, which has so far been extremely well received, in addition to more focused briefings and discussions for our scientists and reviewers…in fact, we may call on some of you in the audience!

What I have been talking about represents dramatic changes. But they are essential and they must happen.

Of course, it won’t be easy. But we are very determined, because of the public health importance of this issue.

However, we are working with constraints.  The resources allocated to countermeasures at FDA are currently restricted to flu activities, and naturally that makes it difficult for us to implement our full vision and plan as aggressively as we would like. Key Congressional leaders recognize the need to make this change, and we are working with them to find ways to remove this restriction.

Despite this constraint, we are moving as fast as we can to build a strong and sustainable program. And as we do so, we will be looking to all of you for counsel and support.

Ultimately, our goal is simple and it is one we all share: we must take all possible action today to ensure the safety, effectiveness, and availability of medical countermeasures tomorrow. We must do our part to speed the development of promising products—and identify those that won’t make the cut as early as possible. And we must incorporate the best, most modern science available into our work.

We are all engaged in efforts that are critical to promoting and protecting the health of the American people. So I urge each of you to use this meeting as an opportunity to summon your sense of possibility and come together in new and unexpected ways. The future of public health in America depends on it, and I applaud you all for your interest and commitment to this common goal.

Thank you.