This week President Bush signed the Pandemic and All-Hazards Preparedness Act (S. 3678). It has generally gotten favorable reviews from public health professionals concerned with preparedness, including the Clinicians Biosecurity Network and The Trust for America’s Health. We’ve taken a look, too, and find much to like, but whether this will indeed be useful will depend on how it’s implemented. We have a few observations of our own, as well.

The law has four Titles, each dealing with a separate but related topic. Title I. pertains to ” National Preparedness and Response, Leadership, Organization, and Planning.” This is an important development because it consolidates federal public health and medical emergency preparedness and response activities within the Department of Health and Human Services (DHHS). For most public health and medical emergencies, the appropriate place to plan and manage them is with public health professionals. Prior to this there was much confusion whether the overall direction would rest within Homeland Security or HHS. This issue seems to have been settled by the stunning display of incompetence by Homeland Security. Who in their right mind would put them in charge of a pandemic? Apparently Congress got the message. The Assistant Secretary who will be in charge is a Presidential appointment but subject to confirmation. Under the Republican Congress of the last 6 years, this would have meant little, with cronyism and political considerations trumping expertise. Under a Democratic Congress we can hope for some responsible oversight. Hope, like pandemics, springs eternal. An interesting requirement is that planning must take account of “at risk individuals,” defined in the legislation to be “children, pregnant women, senior citizens and other individuals who have special needs in the event of a public health emergency, as determined by the Secretary.” The new Disaster Czar ill prepare and submit to Congress a strategy for national security every four years, starting in 2009.

Title II. allows the DHHS to institute a cooperative agreements program (essenially, a grant) with states, local public health and tribal entities. This is a good idea, but much will depend on how much money is allocated, what kinds of flexibility there will be and what the transaction costs are. There is a requirement for a 5 – 10% non-Federal match from the states or elsewhere. This is a pretty good deal, but it is still real money that most state health departments don’t have. Independent audits will be required. Thus what the “strings” are will be all important. If this money can’t be used for more general public health needs, we are likely to see continued erosion of public health infrastructure as personnel are reassigned to allowed activities at the same time state budgets are cut for others. There is also mention of “evidence based benchmarks” to measure progress. States will be required to have pandemic influenza plans and failure to meet the criteria for these plans will result in withholding of the grant funds. What are the criteria? We are supposed to know in 3 months, the deadline for the new Assistant Secretary (yet to be named) to develop and disseminate to each state the criteria for an effective state plan for responding to a pandemic. We’ll have to see how well this requirement takes account of the differences in scale, complexity and individual features of 50 states, numerous local health departments and many tribal authorities. Grants to support state and local public health are desperately needed, but so far federal efforts have been worse than a waste of money. They have seriously distorted public health priorities. I’m anxious that this will be more of the same. We’ll have to see. Title II. also requires the Secretary to establish a “near real-time electronic public health situational awareness capability.” I presume this means a surveillance system. Good luck. This is an extremely difficult problem. But we need one. So we’ll keep our fingers crossed.

An intriguing segment authorizes the secretary to “provide grants to states for tuition loan repayment to individuals who agree to serve for at least 2 years in state, local, or tribal health departments. The loan repayment program will support degree programs appropriate for serving in state, local, and tribal health departments.” (Clinicians Biosecurity Network). This is an extremely important initiative and could be a real boon to state and local public health. I hope this one gets priority and that money is appropriated to pay for it. I won’t hold my breath but I will try to be optimistic.

Title III. formerly transfers some functions previously at Homeland Security to DHHS, strengthens some existing activities and authorizes an increase in CDC’s Epidemic Intelligence Services by 20 more slots. It also requires the Secretary to make grants to hospitals and healthcare facilities to improve surge capacity and enhance community and hospital preparedness. That would be good, wouldn’t it. How they are going to do it is another matter. This doesn’t impress me very much. It’s handwaving.

Title IV. establishes Biomedical Advanced Research and Development Authority (BARDA). This title “integrates biodefense and emerging infectious disease requirements with…advanced research and development, strategic initiatives for innovation, and the procurement of [countermeasure and pandemic] products.” Lots of talk here about facilitating development of new medicines and vaccines, integrating the efforts of government, pharma, academia, promoting innovation, etc., etc. There will be a “Biodefense Medical Countermeasure Development Fund” to get stuff from the bench to the bedside, etc., etc. Even more than at other places in this legislation, the details of how this will be implemented are all important. There is a troubling provision here to exempt BARDA from certain Freedom of Information Act (FOIA) disclosure requirements when the Secretary deems it will endanger national security, or, as the law says it more generally, if the information “reveals significant and not otherwise publicly known vulnerabilities of existing medical or public health defenses.” This seems like a loophole to drive the truck that conceals adverse events to vaccines or drugs or other kinds of information that is dangerous or inconvenient for pharmaceutical companies or the government.

There are some good things here. It is still just enabling legislation and has no money attached to it and lots of blank spaces that need to be filled in. Getting the public health responses out of Homeland Security and into DHHS is a good move. For the rest, we’ll just have to wait and see. This administration has a poor track record.

If you want to read the law for yourself you can find it here (click on Text of Legislation, top of second column).