HLS 24RS-1030 ENGROSSED
2024 Regular Session
HOUSE BILL NO. 815
BY REPRESENTATIVE BILLINGS
HEALTH/LDH: Provides relative to certain federally-regulated information
1 AN ACT
2To enact Subpart E of Part IV of Chapter 5-D of Title 40 of the Louisiana Revised Statutes
3 of 1950, to be comprised of R.S. 40:1176.1, relative to certain federally-regulated
4 information; to require compliance with federal rules and regulations; to assign
5 certain duties to the Louisiana Department of Health; to impose penalties; to require
6 compliance from the Louisiana Department of Health; to provide for applicability;
7 and to provide for related matters.
8Be it enacted by the Legislature of Louisiana:
9 Section 1. Subpart E of Part IV of Chapter 5-D of Title 40 of the Louisiana Revised
10Statutes of 1950, comprised of R.S. 40:1176.1, is hereby enacted to read as follows:
11SUBPART E. RIGHT TO FEDERALLY-REGULATED AND APPROVED MEDI CAL
12 AND PHARMACEUTI CAL INFORMATION
13 ยง1176.1. Right to federally-regulated drug and treatment information; prohibition
14 of noncompliant materials; penalties
15 A. The Louisiana Department of Health shall ensure that all descriptive
16 advertising and promotional materials relating to drugs, pharmaceuticals, medical
17 devices, or vaccines created or displayed by the department follow the respective
18 federal laws and adhere to the United States Food and Drug Administration rules
19 regarding commercial advertising.
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CODING: Words in struck through type are deletions from existing law; words underscored
are additions. HLS 24RS-1030 ENGROSSED
HB NO. 815
1 B.(1) The manufacturer of any drug, pharmaceutical, medical device, or
2 vaccine whose advertisements or related promotional materials are displayed or
3 distributed by the Louisiana Department of Health but are determined by the
4 department to be noncompliant with the provisions set forth in Subsection A of this
5 Section shall receive notice from the Louisiana Department of Health within thirty
6 days of the publication or broadcast of the noncompliant advertisement or material
7 or within thirty days of the determination of noncompliance.
8 (2) The manufacturer shall remedy its noncompliance within thirty days of
9 receiving notice.
10 (3) If, after notice has been received, the thirty-day-period has lapsed, and
11 the drug, pharmaceutical, medical device, or vaccine-related advertisement or
12 promotional material still does not comply with the provisions of this Section, it shall
13 be subject to immediate removal from display or distribution by the Louisiana
14 Department of Health.
15 C.(1) The Louisiana Department of Health shall produce only drug,
16 pharmaceutical, medical device, or vaccine-related advertisements and promotional
17 materials that comply with the provisions of this Section and the regulations set forth
18 by the United States Food and Drug Administration.
19 (2) The Louisiana Department of Health shall promulgate rules as necessary
20 to implement the provisions of this Section.
21 D. This Section shall not apply to entities regulated in accordance with the
22 Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
DIGEST
The digest printed below was prepared by House Legislative Services. It constitutes no part
of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute
part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)]
HB 815 Engrossed 2024 Regular Session Billings
Abstract: Requires the La. Dept. of Health (LDH) to ensure that all descriptive advertising
and promotional material relating to drugs, pharmaceuticals, medical devices, or
vaccinations follow certain federal laws and rules.
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CODING: Words in struck through type are deletions from existing law; words underscored
are additions. HLS 24RS-1030 ENGROSSED
HB NO. 815
Proposed law requires LDH to ensure that all descriptive advertising and promotional
material relating to drugs, pharmaceuticals, medical devices, or vaccinations follow certain
federal laws and rules.
Proposed law provides that the federal rules and regulations relative to commercial
advertisement shall apply.
Proposed law provides that notice of noncompliance shall be given to the manufacturer of
the drug, pharmaceutical, medical device, or vaccine-related advertisement or promotional
material within 30 days of such noncompliant advertisements or promotional material or
within thirty days of the determination of noncompliance.
Proposed law requires the manufacturer to remedy its noncompliance within 30 days of
receiving notice.
Proposed law provides that if, after notice has been received and the 30-day period has
lapsed, the drug, pharmaceutical, medical device, or vaccine-related advertisement or
promotional material shall be subject to immediate removal from display or distribution by
LDH if it continues to be noncompliant.
Proposed law requires LDH to produce only advertisements and promotional materials that
comply with the provisions of proposed law and federal regulations.
(Adds R.S. 40:1176.1)
Summary of Amendments Adopted by House
The Committee Amendments Proposed by House Committee on Health and Welfare to
the original bill:
1. Change references from "medical treatment" to "medical device".
2. Change references from "publication or broadcast" to "display or distribution by
LDH".
3. Remove proposed law provision that requires LDH to utilize existing staff to
implement proposed law.
4. Require all descriptive advertising and promotional material relating to drugs,
pharmaceuticals, medical devices, or vaccinations to comply with the Federal
Food, Drug, and Cosmetic Act.
5. Provide that notice of noncompliance shall be given to the manufacturer of the
drug, pharmaceutical, medical device, or vaccine-related advertisement or
promotional material within 30 days of the noncompliant advertisements or
promotional material or within 30 days of the determination of noncompliance.
6. Make technical corrections.
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CODING: Words in struck through type are deletions from existing law; words underscored
are additions.