Making the CDC Modern

Overview

IFP is a non-partisan research organization dedicated to accelerating scientific, technological, and industrial progress. Biosecurity is a key issue area for us. Our recommendations highlight opportunities to increase the CDC’s responsiveness to future naturally occurring, accidental, or engineered outbreaks. 

Fostering innovation and collaboration

Response to Question 3: Congress should encourage the CDC to increase agility by incorporating off-the-shelf commercial solutions, especially in its early warning systems. 

Context

• The failure of the CDC SARS-CoV-2 PCR test at the beginning of the COVID-19 pandemic highlights the need for robust private-public partnerships between the CDC and industry stakeholders. 
• The CDC has almost 400 early warning systems. Rather than leverage and modify existing system infrastructure during COVID-19, the agency added around 5 additional systems. Incorporating commercial next-generation detection technology into their system architecture would ensure more agile systems capable of responding to the changing biothreat landscape. While the CDC has partnered with innovative companies like Biobot Analytics to develop the National Wastewater Surveillance System, adopting more commercial solutions will increase responsiveness going forward. 

Recommendations 

• Congress should support the development of different types of economic incentives to allow the CDC to incorporate competitive next-generation health technology and capabilities into its prevention and response. 
  • For instance, Congress could authorize the CDC to establish a body similar to the Loan Office Program at the Department of Energy. Through this program, the CDC could publish specific target product profiles for priority areas, for which companies could apply for loan guarantees. The potential utility of such loans is broad. For example, as wastewater early warning systems expand, the CDC could issue a target product profile for next-generation multiplexed platforms and sequencers that could better identify a range of known and unknown biothreats in wastewater systems. The CDC could then partner with companies to pilot and deploy these tools. 

Building external partnerships

Response to Question 5: Congress should encourage the CDC to strengthen its external partnerships to support its prevention and response mission.

Context

• Interagency: Public health emergencies over the past few years have highlighted the need for the roles and responsibilities of the CDC, Federal Emergency Management Agency (FEMA), and the Administration for Strategic Preparedness and Response (ASPR) to be clarified in outbreak detection and response.
• Private Sector: The CDC needs to work closely with industry partners so that it can incorporate cutting-edge commercial solutions to address the emerging range of biothreats. 

Recommendations

• Interagency: Congress should conduct oversight, in the form of a public hearing or briefing, to ensure CDC, FEMA, and ASPR are coordinating effectively. Specifically, it should ensure that responsibilities during public health emergencies are clearly articulated and executed.
• Private Sector: Congress should encourage the CDC to adopt new strategies of industry engagement to ensure that next generation health technologies and capabilities are being incorporated into federal disease prevention and response. 
  • Similar to BARDA Industry Day, CDC could hold events across biotechnology hubs for employees to engage with industry stakeholders. These events would provide opportunities for both the CDC and industry to present their current work and priorities. 
  • CDC could also establish a platform similar to the Biomedical Advanced Research and Development Authority’s (BARDA) TechWatch, a process BARDA uses to engage industry on promising new technologies. CDC could use a similar platform to specify target product profiles for next-generation health technology it is most interested in, and allow industry stakeholders to submit requests for meetings pertaining to one or more of the target product profiles. CDC should invite broad USG participation from entities like the Food and Drug Administration or BARDA in the resulting industry presentations. CDC should also provide clear follow-up after these industry presentations to help partners easily identify next steps. 

Making data work for everyone

Response to Question 1: Congress should require the CDC to develop an integrated and layered early warning data system. Consultation with state, local, tribal, and territorial (SLTT) partners will be essential to ensure data interoperability and usability so local health decision-makers have access to timely situational awareness.

Context

• Currently, states report some of their data to the CDC, but receive no public real-time analysis in return. This asymmetrical sharing of information is in part caused by internal CDC incentives, which are geared more towards publishing definitive analyses than to providing real-time situational awareness that informs decision-makers and clinical practitioners.
  • Current syndromic surveillance approaches monitor for the rapid onset of serious symptoms. This type of early warning system misses mildly symptomatic or asymptomatic threats, and does not identify the pathogen responsible for an outbreak. The CDC must incorporate molecular pathogen-agnostic early warning layers to detect both known and unknown pathogens, regardless of symptomatic presentation. Multiplexed platforms should also be used to test for multiple pathogens at once. 
• The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) required HHS to create a nationwide electronic early warning system. In 2017, the GAO made a series of recommendations for HHS to adopt this capability. Five years later, none of these recommendations have been addressed. 
• The CDC must implement a centralized real-time public health situational awareness capability, taking on the role as a federal-level collector of early warning data.

Recommendations

• Congress should require the CDC to make real-time early warning data publicly available, along with analysis of disease trends to inform policy and clinical practice. 
  • Just as the Missile Defense Agency (MDA) integrates data from multiple sources, such as space, border, sea, and forward operating bases, the CDC needs to centralize the nation’s biothreat data, improving the national ability to respond to rapidly evolving public health emergencies. 
• One option is to expand the Morbidity and Mortality Weekly Reports by incorporating molecular data streams from sources such as health clinics, air travel, and wastewater treatment facilities.
• Congress should ensure that CDC’s early warning system is pathogen-agnostic. This means it should detect, identify, and characterize all biological threats, regardless of whether they are accidental, engineered, or naturally occurring.
  • A robust early warning system incorporating molecular signals (such as wastewater data) would ensure that a localized outbreak in San Francisco doesn’t require future containment measures in Alabama.
    • Similar to the MDA use and operation of sophisticated technologies, the CDC must leverage advanced technologies, such as multiplexed platforms and metagenomic sequencing, to ensure that all biological threats can be addressed. 
  • Broad stakeholder engagement is key to successful implementation. Congress should call on the CDC to work closely with SLTT partners and industry in developing a robust surveillance system and ensure data usability. 
• Congress should require the CDC to frequently share relevant data with the Federal Bureau of Investigation (FBI) and the intelligence community at large to strengthen bio-attribution capabilities and combat deliberate misuse. 

Systematizing early-warning

Response to Question 6: Congress should ensure that requirements for a centralized early-warning system that is integrated across the different disease/pathogen-specific CDC teams.

Context

• Congress should require the CDC to invest in both pathogen-specific and pathogen-agnostic data collection systems. Pathogen-agnostic systems are needed to identify all circulating threats, while pathogen-specific systems can provide helpful follow-up. Pathogen-agnostic data collection can routinely monitor human threats (especially mildly symptomatic or latent infections), and monitor plant and animal threats in coordination with USDA.
• Pathogen- or disease-specific systems can help identify epidemiological trends across different populations, as well as in events with only a few symptomatically infected individuals. For example, two imported cases of a hemorrhagic fever would likely be flagged by a medical practitioner before there was sufficient domestic spread to be credibly flagged by wastewater monitoring. However, for infections for which most cases display milder symptoms, like the recent mpox and polio outbreaks, wastewater provided a more accurate measure of burden, as many mildly affected individuals did not seek medical services.

Recommendations

• Congress should require the CDC build one centralized federal early warning system that is integrated across the different disease/pathogen-specific CDC teams.
• This early warning system should have a mechanism that allows the CDC Center for Forecasting and Analytics (CFA) to easily access disease- and pathogen-specific CDC experts as they review early warning data, to ensure integration across the agency.
• Congress should also ensure CFA maintains a small and agile team able to attract high-skilled talent through contracting; rotations of data science experts from industry; and exemption from the GSA pay scale.

Improving upon what works well

Response to Question 11: Congress, with input from the CDC, should reaffirm and clarify CDC’s role in preventing, detecting, and responding to infectious disease outbreaks.

Context

• Currently, CDC’s institutionally incentivizes publishable, definitive analysis over publicly accessible, real-time situational awareness to inform policy-makers and clinical practice. 
  • For example, the seasonal flu of 2017-2018 had a high rate of severe disease and death, yet the CDC delayed providing public guidance until it had done a definitive analysis. CDC eventually determined that the season’s flu vaccine was only 25% effective against the predominant strain of influenza, A H3N2. Had institutional incentives (which promote accuracy over speed) been more aligned with the realities of the developing flu season, the CDC might have taken earlier action to inform healthcare services about anticipated burden, and educated the public about actionable behavioral changes that could have saved lives. 
• Additionally, the roles and responsibilities of the CDC, FEMA, and ASPR in outbreak detection and response should be reaffirmed to help clarify CDC’s detection and response mission. 

Recommendations 

• Congress should clarify the mission of CDC, drawing on its history as an operational agency. While parts of the CDC can focus on publication productivity, the agency itself must be at the forefront of public health practice, which includes early adoption. The CDC’s own structural review highlighted the need to refocus on operational readiness. 
• Congress should hold a closed briefing with the CDC to learn from the agency how it intends to incentivize public health responsiveness (through hiring, performance reviews, promotions, and other measures). 
• Congress should encourage more agency-wide strategies and policies in order to address existing silos that impede coordinated timely response and support functions. This should also include articulating roles and responsibilities (including reporting practices) within CDC. 
• Congress should encourage CDC, FEMA, and ASPR to conduct joint exercises to ensure clear operational roles and responsibilities during disease outbreaks and other public health emergencies. Exercises should adhere to the guidelines and goals of the Public Health Emergency Preparedness Cooperative Agreement Program, the National Response Framework and the National Incident Management System, and should incorporate federal, SLTTs, and private sector stakeholders. 

Mechanisms to modernize

Response to Question 6: Congress should encourage the CDC to create a national policy on field biosafety. 

Context 

• The Office of the Director of National Intelligence flagged the lack of field biosafety standards as cause for concern, especially given increased field sampling and advanced research, in its 2023 Annual Threat Assessment. These concerns may apply to the sampling of humans or animals in field settings. Policymakers have recently become concerned, for instance, about the potential spillover risks from bat field research and sampling if best biosafety practices are not adhered to.
• Field biosafety for research teams is typically overseen at the institutional level (e.g. by university Institutional Animal Care and Use Committees, or Institutional Review Boards). Processes used in the field for animal sampling are often designed by investigators based on best field practices published to date, as there are no federal or internationally-agreed upon field biosafety standards. Oversight of the design and implementation of the processes is by default relegated to institutions and project funders, and is executed absent a comprehensive standard, federal or otherwise, against which to oversee the field activity.

Recommendation

• Congress should convene field research funders and biosafety experts from the interagency, including NIH, CDC, DOD, USAID, USDA, and other agencies that fund and oversee field pathogen sampling to discuss the need for biosafety best practices for such work and determine an agency lead for the establishment of a field biosafety standard. 
  • Congress should require the CDC, with collaboration from the NIH, to create a national field biosafety manual, similar to the Biosafety in Microbiological and Biomedical Laboratories (BMBL), in order to provide comprehensive federal guidance to field researchers.