SB 1031 - HB 1157
FISCAL NOTE
Fiscal Review Committee
Tennessee General Assembly
February 21, 2025
Fiscal Analyst: Chris Higgins | Email: chris.higgins@capitol.tn.gov | Phone: 615-741-2564
SB 1031 - HB 1157
SUMMARY OF BILL: Enacts the Restore Trust in Public Health Messaging Act.
Prohibits the Department of Health (DOH), the Commissioner of DOH (Commissioner), an
employee or agent of the DOH, an employee or agent of a local health department, and the state
executive branch from directly or indirectly promoting, distributing, or endorsing information
regarding a Food and Drug Administration (FDA)-regulated product in a manner that conflicts with
or does not accurately reflect the FDA-approved or FDA-authorized label for such product.
Establishes that if such individual or entity refers a healthcare provider or the general public to
information about FDA-regulated products from sources not covered by the legislation, then the
referral must include a warning that the entity for which the employee or agent is providing such
information is not regulated.
Requires the Commissioner and the state executive branch to establish an internal review process by
July 1, 2025 to ensure compliance with FDA labeling standards in all communications, educational
materials, and public health campaign. Requires the Commissioner and the state executive branch to
submit an annual report to the Comptroller of the Treasury (COT), the Clerk of the Senate, the
Clerk of the House of Representatives, and the Legislative Librarian no later than January 15, 2026,
and on or before January 15 of each subsequent year, that details the efforts of the Commissioner
and the state executive branch to comply with the legislation.
Requires the COT to establish a process on before July 1, 2025 by which individuals may submit
information concerning violations or suspected violations of the legislation. Requires the COT to
investigate complaints concerning alleged or suspected violations of the legislation and complaints
of retaliation against an individual who reported an alleged or suspected violation.
Requires the DOH, the Commissioner, each local health department, the state executive branch, and
each recipient of a federal grant, state grant, or other funds or inducements distributed by the state
to remove from public distribution all existing informational materials, whether in printed or
electronic format, that are not in compliance with the legislation, by January 15, 2026.
Establishes that an employee or agent who violates the legislation is subject to disciplinary action,
which may include termination of employment or agency agreement. Establishes that a violation of
the legislation by an entity that receives state grants or funds, federal grants or funds distributed by
this state, or other forms of financial inducement, is subject to a civil penalty not to exceed three
times the amount of state resources misused in the commission of the violation, or $50,000,
whichever is greater. Such entity in violation is ineligible to receive grants, funds, or other
inducements for a period of up to 10 years, to be determined by the COT, based on the severity of
the violation.
SB 1031 - HB 1157 2
FISCAL IMPACT:
STATE GOVERNMENT
EXPENDITURES General Fund
FY25-26 $500,700
FY26-27 & Subsequent Years $485,700
Total Positions Required: 3
OTHER FISCAL IMPACT
The Department of Health and county health departments will experience an increase in
expenditures as a result of dispensing costlier medications to patients. The amounts of such
increases are dependent on a number of unknown factors, including the results of the department's
compliance review, and cannot be reasonably estimated.
Assumptions:
• The COT cannot accommodate the proposed legislation within existing resources.
• In order to expand the responsibilities of the Division of Investigations, the COT will
require three additional positions (two Senior Investigator positions, one Investigate
Counsel position), beginning in FY25-26.
• The recurring increase in state expenditures is as follows:
• There will be a one-time increase in state expenditures in FY25-26 of $15,000 for supplies
and training.
• The COT investigators will also need to contract with a nurse practitioner to consult on the
proper usage of FDA-approved products.
• It is estimated that the COT will contract for 900 hours of consulting work per year, at an
hourly rate of $75 per hour, resulting in a recurring increase in expenditures of $67,500 (900
x $75) in FY25-26 and subsequent years.
• A total increase in state expenditures of $500,664 ($418,164 + $15,000 + $67,500) in FY25-
26, and $485,664 ($418,164 + $67,500) in FY26-27 and subsequent years.
• The DOH can conduct the required review of compliance with FDA labeling standards and
submit the required report utilizing existing personnel and resources.
• According to information provided by DOH, local health departments currently dispense
drugs for off-label usage as part of the regular practice of medicine, which would no longer
be allowed by the proposed legislation.
Title Salary Benefits # Positions Total
COT-Senior Investigator $105,000 $25,448 2 $260,896
COT-Investigative Counsel $128,004 $29,264 1 $157,268
Total: $418,164
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• Prohibiting the DOH and county health departments from dispensing or prescribing certain
FDA-approved products for off-label usage will result in an increase in state and local
expenditures when more expensive medications are required.
• The total amounts of such increases are dependent on a number of unknown factors,
including the results of DOH's compliance review, and cannot be reasonably estimated.
CERTIFICATION:
The information contained herein is true and correct to the best of my knowledge.
Bojan Savic, Executive Director