Consolidating Or Coordination

Lurie’s post, created by the original PAHPA law, was intended to create a “buck-stops-here” for emergency health preparedness coordination. However, much of the work is still done outside Lurie’s office, not only in other HHS agencies, but in the military, VA and DHS. Asked if she thought the work should be further consolidated, Lurie said she believed HHS was cooperating well with other agencies and further consolidation was not necessary.

“I think we've developed a much closer and more collaborative relationship with DHS on the issues that relate to the determination of threats. And I think we have been able to make much more robust our requirement-setting process so that we actually can work much more collaboratively with the other agencies around setting those requirements and then actually doing the research and development and getting the countermeasures made and licensed,” Lurie said. “Likewise, we've worked much more closely with DoD in the integrated portfolio aspects of this.”

She cited the work HHS and DoD did together in Haiti as a prime example of good cooperation with military response efforts. In Haiti HHS officials worked with military responders to direct resources and to transfer patients from danger zones to refugee camps or temporary health facilities.

“On the countermeasure side of it, we have a portfolio where we and DoD sit together and talk about what to do,” Lurie said. “We formally have liaisons between our two offices, so we can coordinate better. And we work with DoD partners on a number of different issues, including patient movement during a disaster, such as in Haiti.”

Building A Better Flu Vaccine

With flu season coming up, some legislators expressed concern about the vaccine stockpile, notably the supply of adjuvants — chemicals added to the vaccine supply to improve immune response and stretch the vaccine supply. Last year, President Obama set a goal that the U.S. would have two approved adjuvants to assist with the seasonal flu vaccine effort. Currently, none are approved.

“We have invested and continue to invest in the development in adjuvant vaccines,” Lurie said. “Adjuvants may well be one of the answers to a more effective influenza vaccine going forward. My understanding right now is that FDA is poised to act on applications for adjuvant vaccines when they receive them. I think, for seasonal flu vaccine, that is the situation. We’ve been really redoing how we’ve done some of the [FDA regulatory] governance, so there should be fewer delays and fewer surprises when we get to that point.”

There is also the possibility, if a drug is still in the development pipeline, of deploying it under an emergency use authorization. However, that brought up a concern among legislators that relying on emergency use could result in delays in getting drugs to a population.

“As PAHP comes up for renewal, we’re going to have to look and see if we need to redefine emergency use authority and the threshold for that,” noted Sen. Richard Burr (R-N.C.). If we don’t, we could find ourselves in a situation where we have a real threat and an inability to respond in a timely fashion, much like how we saw in H1N1. There were delays in getting the emergency use authorization, and kids died because we couldn’t authorize that fast enough. No one was to blame. It was just about the speed that we could get things done.”

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