Following are key provisions of the proposed economic stimulus of interest to public health entities.

  • Research and Infrastructure
  • Comparative Effectiveness Research
  • Prevention and Wellness
  • Medical Product Development and Procurement

Research and Infrastructure

The stimulus proposes to make new funding available for research activities and infrastructure to support research. Funding would be directed to:

National Science Foundation: $3 billion, including $2 billion for expanding employment opportunities in fundamental science and engineering to meet environmental challenges and to improve global economic competitiveness; $400 million to build major research facilities that perform cutting edge science; $300 million for major research equipment shared by institutions of higher education and other scientists; $200 million to repair and modernize science and engineering research facilities at the nation's institutions of higher education and other science labs; and $100 million to improve instruction in science, math and engineering.

National Institutes of Health Biomedical Research: $1.5 billion for the National Center for Research Resources to renovate or repair university research facilities and provide other support that assists universities in competing for biomedical research grants. Priority for renovation or repair grants is given to applicants who expect to generate demonstrable energy-saving or beneficial environmental effects. $1.5 billion for the Office of the Director to support 21st century science, engineering and biomedical research to bring the nation needed health breakthroughs. Stakeholders should engage on whether these effects derive from the construction itself or from the research.

Department of Energy: $1.9 billion for basic research into the physical sciences including high-energy physics, nuclear physics, and fusion energy sciences and improvements to DOE laboratories and scientific facilities. $400 million is for the Advanced Research Project Agency. The Department of Energy will support high-risk, high-payoff research into energy sources and energy efficiency.

Biomedical Advanced Research and Development, Pandemic Flu, and Cyber Security: $900 million to prepare for a pandemic influenza, support advanced development of medical countermeasures for chemical, biological, radiological, and nuclear threats, and for cyber security protections at the Department of Health and Human Services (HHS), including funding for the facilities involved in vaccine and biologics responses to pandemic flu. Of the $900 million,

  • $430 million for Biomedical Advanced Research and Development Authority (BARDA) procurement and advanced development of medical countermeasures for chemical, biological, radiological and nuclear agents (i.e., products that are in clinical trials but are not yet cleared for marketing by FDA);
  • $420 million for pandemic flu preparation, including development and purchase of vaccine, antivirals, necessary medical supplies, diagnostics and other surveillance tools (including construction of facilities related to vaccines and biologics) for potential eventual deposit in the Strategic National Stockpile.

Stakeholders should rapidly become familiar with the divergent requirements of BARDA, BioShield, the Stockpile, and the Pandemic Flu Plan for funding requirements that vary.

Stakeholders have an opportunity to engage the BARDA office within the Office of the Assistant Secretary for Preparedness and Response (ASPR), as well as other ASPR units on the merits of their products and their eligibility for ASPR funding under this bill and other existing funding.

While the pandemic flu spending plan is currently in place and funding under this bill will presumably be devoted to procurements consistent with the plan, stakeholders with related products may wish to take advantage of the new administration and seek modifications to the current spending plan.

National Institute of Standards and Technology: $300 million for competitive construction grants for research science buildings at colleges, universities, and other research organizations and $100 million to coordinate research efforts of laboratories and national research facilities by setting interoperability standards for manufacturing.

Comparative Effectiveness Research

The stimulus would provide $1.1 billion to the Department of Health and Human Services (HHS) for comparative effectiveness research. Much or all of the funding can either “support” research done by others or can be conducted by the Agency itself (e.g., by NIH). All products, procedures, and services are intended to be subject to comparative effectiveness evaluation.

Whether comparative effectiveness funding can be used for cost-effectiveness studies remains an open question. The reference to “appropriateness of items” is potentially intended to permit such studies. (Similar language is used in section 1013 of the Medicare Modernization Act, and section 1013 is a permitted use of the funds under the stimulus bill.) Stakeholders should consider working with agencies and the Hill to ensure that these studies are only done if appropriate and consistent with patient interests.

The public is expressly given the opportunity to comment on research findings, but need only be consulted to the "extent feasible."

Within 90 days of the bill passing and before providing the funding (in either 2009 or 2010), the Secretary shall provide the Appropriations Committees (but not necessarily the public or others) an operating plan for use of the funds. Stakeholders should seek to influence this plan before it goes out and should strive to get access to the plan after it is finalized.

Funding for comparative effectiveness research would be disbursed across HHS:

  • $300 million to the Agency for Healthcare Research and Quality (AHRQ). AHRQ has substantial experience with this type of research, but is not accustomed to this level of funding.
  • $400 million to the National Institutes of Health (NIH). The NIH money may go to specific Institutes or to the Common Fund but the formula is not dictated (unlike in other provisions of the bill). Stakeholders should consider influencing where the funding is directed to ensure maximum impact.
  • $400 million to be used at the discretion of the Secretary of HHS. This money is expected be used to “encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data.” Organizations with experience in setting up or running registries or ensuring the quality and appropriate conduct of data banks should consider involvement. The implications for open access to research results and open data policies should be explored.
  • The Secretary may delegate his authority to spend the money to other Agencies or to private-sector entities. That money is intended to “accelerate the development and dissemination” of comparative effectiveness research, so the money could be spent on research itself or planning and other activities not directly considered research. "Appropriate entities” can participate in this funding, including organizations not traditionally considered “scientific,” such as consulting, social behavior, or other entities that have demonstrated experience and capacity to achieve the goals of comparative effectiveness research.
  • A new Federal Coordinating Council will assist the Administration with coordinating comparative effectiveness research and will provide stakeholders with another opportunity/obligatory point of contact to ensure appropriate policy. Half of the members of the Council will be drawn from the physician/provider community. Stakeholders should consider membership in the Council or otherwise communicating appropriate priorities and methods to the Council.
  • The Institute of Medicine must make recommendations on national (not local or regional) comparative effectiveness research priorities by June 2009. Stakeholders are expressly urged to engage in developing these priorities.

Prevention and Wellness

The bill proposes a $3 billion fund to fight preventable chronic and infections diseases, including:

  • $954 million for the Centers for Disease Control and Prevention (CDC) discretionary immunization program in public health departments;
  • $1.5 million to the Institute of Medicine (IOM) for a report on prevention and wellness priorities;
  • $150 million for hospital infection prevention;
  • $60 million for injury prevention; and
  • $335 million for domestic HIV/AIDS, viral hepatitis, STDs, and TB prevention.

Many of these funds are intended for services and "programs," including education, planning and strategy development, and stakeholders will need to position themselves with agencies as eligible providers.

Stakeholders should also assess opportunities to further target the spending of those funds, whether through the priority development process at the Institute of Medicine (IOM) or directly with the agencies and Capitol Hill.

In addition, funding under the programs can include product development or procurement, and manufacturers, in particular, should assess whether products such as vaccines, anti-virals, drug-delivery devices like syringes, diagnostics, or infection-reducing products used in surgery might qualify for development or purchase.

Medical Product Development and Procurement

The stimulus proposes that $850 million be directed to the Public Health and Social Services Emergency Fund (PHSSEF), including:

  • $430 million for Biomedical Advanced Research and Development Authority (BARDA) procurement and advanced development of medical countermeasures for chemical, biological, radiological and nuclear agents (i.e., products that are in clinical trials but are not yet cleared for marketing by FDA);
  • $420 million for pandemic flu preparation, including development and purchase of vaccine, antivirals, necessary medical supplies, diagnostics and other surveillance tools (including construction of facilities related to vaccines and biologics) for potential eventual deposit in the Strategic National Stockpile.

Stakeholders should rapidly become familiar with the divergent requirements of BARDA, BioShield, the Stockpile, and the Pandemic Flu Plan, for funding of products, requirements that vary depending on the stage of product development, status of FDA review, status of commercial market, and other requirements.

Stakeholders have an opportunity to engage the BARDA office within the Office of the Assistant Secretary for Preparedness and Response (ASPR), as well as other ASPR units on the merits of their products and their eligibility for ASPR funding under this bill and other existing funding.

While the pandemic flu spending plan is currently in place and funding under this bill will presumably be devoted to procurements consistent with the plan, stakeholders with related products may wish to take advantage of the new administration and seek modifications to the current spending plan.