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Regulatory Response and Advocacy

APHL promotes the work of public health laboratories by advocating for a sustainable laboratory network and voicing the impact of federal policies and regulations. We tell the public health laboratory story—why the work is important, what would happen if it stopped and what could be accomplished with additional funding. 

Questions?

Contact the Public Policy and Regulatory Affairs team: [email protected]

BUDGET AND ACTIVITY RECOMMENDATIONS

Our Advocacy Priorities

Federal Policy Recommendations

Hill Day fact sheets are legislative handouts describing priority issues and budget requests. They are shared with federal legislators and their staff to advocate for a strong public health laboratory system, which includes funding for cooperative agreements, critical infrastructure and test advancements. 

Elevating Key Messages Through Partnerships

We work with public health partners on issues affecting public health laboratories and the laboratory system. Key messages are collaboratively developed and shared through communications, Hill Day events and meetings. Our partnership with organizations like those listed below helps refine, standardize and elevate our core messages, creating greater impact on our audiences.

Alliance for a Stronger FDA

The Alliance for a Stronger FDA is an organization of over 150 members that educates Congress, the media, and the public on the FDA mission. They also advocate for adequate funding so FDA can achieve their priorities.

CDC Coalition

The CDC Coalition is organized by the American Public Health Association (APHA). It works to strengthen our nation’s public health infrastructure by advocating for adequate funding so CDC can fulfill its disease prevention mission.

Coalition for Health Funding

The Coalition for Health Funding advocates for investments in all federal agencies because achieving the goal of helping people live healthier, longer lives requires many interdependent programs. 

Coalition to Stop Flu

The Coalition to Stop Flu advocates for federal policies and funding to prevent deaths from seasonal and pandemic influenza.

Data: Elemental to Public Health Campaign Partners

The Data: Elemental to Public Health Campaign Partners advocate for investments to improve the public health data infrastructure. These are the systems and workforce needed to securely exchange data between health care and public health systems to confront any emerging health threat. 

Friends of the National Institutes of Health National Institute of Environmental Health Sciences

The National Institutes of Health Institute of Environmental Health Sciences (NIH NIEHS) conducts research to understand how the environment influences health. The Friends of the NIH NIEHS is a coalition of environmentally and public health-focused organizations that support and advocate for this important work.

Medical and Public Health Laboratory Workforce Coalition

The Medical and Public Health Laboratory Workforce Coalition provides targeted outreach to strengthen the laboratory workforce and assure continued high-quality patient care. The Coalition addresses gaps in personnel recruitment and retainment, accredited training programs, and career progression opportunities.

Newborn Screening Coalition

The Newborn Screening Coalition advocates for the investments and policies needed to ensure every baby has the opportunity for a healthy start.

On Your Behalf

Our Advocacy In Action

Preserving Expert Guidance on Federal Activities

APHL stays informed of the latest federal funding, agency staffing and advisory committee changes that impact public health laboratories. We update our members and use their feedback to guide when to respond with formal communications. The following are recent letters to Congress and White House leadership.

  • Lette​rs​​ to House appropriations and Senate​ leader​​ship​ on providing funding to the​​ CDC to establish pediatric reference interval levels (August 2025)
  • Letter to congressional appropriations staff on funding Health and Human Services at a level that meets vital needs (July 2025)
  • Comments in response to the Department of Education Notice of Proposed Rulemaking Reimagining and Improving Student Education (March 2026)
  • Letter to Secretary Kennedy on reinstating CDC staff at the Division of STD Prevention (DSTDP) and the Division of Viral Hepatitis (DVH) (April 2025)
  • Letter to Secretary Kennedy on reinstating staff at the CDC Division of Blood Disorders and Public Health Genomics (DBDPHG) (April 2025)
  • Letter to Secretary Kennedy on reinstating the Clinical Laboratory Improvement Advisory Committee (CLIAC) (June 2025)​
  • Letter to Sec​retary Kennedy on scheduling a meeting of the President’s Advisory Council on Combating Antibiotic Resistant Bacteria (PACCARB) (June 2025)
  • Letter to Secretary Kennedy on reinstating the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) (May 2025)

Federal Support for Public Health Laboratory Operations

APHL also responds to federal changes that influence public health laboratory operations and their ability to achieve their mission, such as reduced cooperative agreement funding. The following are recent communications describing what public health laboratories need to meet their goals and the work that will stop without federal support.

On Your Behalf

Our Response to Laboratory Developed Test Oversight

In May 2024 the US Food and Drug Administration (FDA) published a Laboratory Developed Test (LDT) final rule that changed the definition of in vitro diagnostic devices (IVDs) to include LDTs manufactured by a laboratory, making LDTs subject to FDA oversight. Multiple laboratory-focused organizations spoke out against this change and the FDA was sued. In September 2025, the FDA reverted to the original IVD definition, meaning that public health laboratory LDTs are once again not subject to FDA oversight.

The Food, Drug and Cosmetic Act (FD&C) gives the FDA authority to regulate medical devices, including IVDs used to test human specimens. LDTs are a type of IVD and there have been many legislative attempts to regulate them. None of the proposed legislation has become law, so in May 2024 the FDA published the LDT final rule and changed the definition of IVD to include LDTs manufactured by a laboratory. This made LDTs subject to FDA oversight.

Multiple laboratory-focused organizations immediately spoke out against this change and the FDA was sued. On March 31, 2025 a judge in the US District Court for the Eastern District of Texas vacated and set aside the rule, which means the LDT final rule is no longer in effect. The judge agreed with the plaintiffs that LDTs are laboratory test services subject to regulation by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The judge reviewed the FD&C Act and interpreted medical devices to mean tangible goods (like manufactured test kits) and not services ordered by physicians (LDTs) and therefore the FDA lacks regulatory authority. Then on September1 9, 2025 the FDA issue a notice that the definition of IVDs was reverted to how it was prior to May 2024 to be compliant with the court ruling. Public health laboratory LDTs are once again not subject to FDA oversight.

Speaking Out on Behalf of Members

APHL has communicated our members’ interest in quality laboratory testing and processes that do not restrict their ability to adapt to meet public health needs to FDA, Congress and federal agencies frequently over the years. We will continue advocating on your behalf should interest in LDT oversight resume.

LDT Resources

APHL and its members are committed to ensuring that the testing performed in public health laboratories is of the highest quality and meets all federal regulatory requirements. Below are resources to support laboratories in the development and implementation of new tests.