What's happening
This bill requires drug manufacturers to disclose clinical trial information in advertisements and pay annual fees to support public education on drug safety in New York.
Why it matters
Increases transparency for consumers. By requiring drug manufacturers to publicly post detailed information about clinical trials—including the sponsor, purpose, dates, and results (including adverse effects)—the bill empowers patients and healthcare providers to make more informed choices and scrutinize the evidence behind drug advertisements.
Supports public health oversight. The annual fees from manufacturers fund state initiatives that monitor drug safety and the impact of prescription drugs on New Yorkers, potentially enabling faster identification of harmful drugs or problematic marketing practices.
Promotes public education on drug safety. The bill mandates a state-run education initiative to improve public understanding of clinical trials and drug safety, helping residents better interpret drug advertisements and weigh risks versus benefits.
Creates stronger accountability for drug companies. With daily penalties for non-compliance and a legislative report on the accessibility of disclosed information, the bill establishes ongoing oversight mechanisms to ensure manufacturers meet transparency and disclosure requirements.
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Who cares
Headline styles
Disclose Drug Ad Trials
Plain English, a few words. Used as the page title.
Sponsors
Senator · Senate District 38
No co-sponsors yet.
History
- Referred to health
- Referred to health
Full text
2 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
6103
2019-2020 Regular Sessions
IN SENATE
May 16, 2019
Introduced by Sen. CARLUCCI -- read twice and ordered printed, and when printed to be committed to the Committee on Health
AN ACT to amend the public health law, in relation to advertising by drug manufacturers and the disclosure of clinical trials
The People of the State of New York, represented in Senate and Assembly, do enact as follows:
Section 1. The public health law is amended by adding a new section 277-a to read as follows:
§ 277-a. Prohibitions and required disclosures; prescription drug advertising. 1. Definitions. As used in this section, unless the context otherwise indicates, the following terms shall have the following meanings:
(a) "Clinical trial" means a clinical investigation as defined by the federal Food and Drug Administration that involves any trial to test the safety or efficacy of a drug or biological product with one or more human subjects and that is intended to be submitted to, or held for inspection by, the federal Food and Drug Administration as part of an application for a research or marketing permit.
(b) "Manufacturer of prescription drugs" or "manufacturer" means a manufacturer of prescription drugs or biological products or an affiliate of the manufacturer or a labeler that receives prescription drugs or biological products from a manufacturer or wholesaler and repackages those drugs or biological products for later retail sale and that has a labeler code from the federal Food and Drug Administration under 21 Code of Federal Regulations, 2027.20 (1999).
(c) "Regulated advertisement" means the presentation to the general public of a commercial message regarding a prescription drug or biological product by a manufacturer of prescription drugs that is:
(i) Broadcast on television or radio from a station that is physically located in the state;
(ii) Broadcast over the Internet from a location in the state; or
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD11791-01-9
S. 6103 2
(iii) Printed in magazines or newspapers that are printed, distributed or sold in the state.
2. Regulated advertisement requirement. Beginning October fifteenth, two thousand twenty, a manufacturer may not present or cause to be presented in the state a regulated advertisement, unless such advertisement meets the requirements concerning misbranded drugs and devices and prescription drug advertising of federal law and regulations under 21 United States Code, Sections 331 and 352(n) and 21 Code of Federal Regulations, Part 202 and state rules and regulations.
3. Disclosure of clinical trials of prescription drugs. Beginning October fifteenth, two thousand twenty, a manufacturer or labeler of prescription drugs that is required to report marketing costs for prescription drugs shall post, with regard to such prescription drugs, on the publicly accessible Internet website of the federal National Institutes of Health or its successor agency or another publicly accessible website the following information concerning any clinical trial that the manufacturer conducted or sponsored on or after October fifteenth, two thousand nineteen:
(a) The name of the entity that conducted or is conducting the clinical trial;
(b) A summary of the purpose of the clinical trial;
(c) The dates during which the trial is taking or has taken place; and
(d) Information concerning the results of the clinical trial, including potential or actual adverse effects of the drug.
In order to satisfy the requirements of this subdivision, the publicly accessible website and manner of posting shall be acceptable to the department.
4. Fees. Beginning April first, two thousand twenty-one, each manufacturer of prescription drugs that are provided to persons through a state public health plan as defined in subdivision eleven of section two hundred seventy of this article shall pay a fee of one thousand dollars per calendar year to the department. Fees collected under this subdivision shall be used to cover the cost of overseeing implementation of this section, including but not limited to maintaining links to publicly accessible websites to which manufacturers are posting clinical trial information under subdivision three of this section and other relevant sites, assessing whether and the extent to which New York residents have been harmed by the use of a particular drug and undertaking the public education initiative under subdivision five of this section. Revenues received under this subdivision must be deposited into a general fund to be used for the purposes of this section.
5. Public education initiative. The department shall undertake a public education initiative to inform residents of the state about clinical trials and drug safety information.
6. Penalties. Each day a manufacturer is in violation of this chapter is considered a separate violation. Such manufacturer shall be subject to the penalties prescribed in section twelve of this chapter.
§ 2. Report. By January 15, 2021, the department of health shall report to the Legislature matters on the completeness and ease of public access to information provided by the drug manufacturers and the need for further action or legislation.
§ 3. This act shall take effect on the one hundred eightieth day after it shall have become a law. Effective immediately, the addition, amendment and/or repeal of any rule or regulation necessary for the implementation of this act on its effective date are authorized to be made and completed on or before such effective date.
Reflowed for reading: line numbers and page breaks removed. Cite the official text.
Sponsor's memo
Title of bill
An act to amend the public health law, in relation to advertising by drug manufacturers and the disclosure of clinical trials
Purpose or general idea of bill
Establishes regulations regarding the advertising of pharmaceutical drugs and requires that the Department of Health submit a report to the Legislature.
Summary of specific provisions
Section 1: This bill requires the Department of Health to adopt rules incorporating by reference federal laws and regulations concerning misbranded drugs and devices and prescription drug advertising.
The bill also requires drug manufacturers to provide information concerning clinical trials of prescription drugs advertised in the State, provides immunity for disclosure of that information, directs the department to maintain this information on an Internet website and enables the department to collect a fee from manufacturers to support a clinical trial database.
Section 2: Report. By January 15, 2021, the department of health shall report to the Legislature matters on the completeness and ease of public access to information provided by the drug manufacturers and the need for further action or legislation.
Section 3: Effective Date.
Justification
Direct-to-consumer pharmaceutical advertising (DTCPA) has grown rapidly during the past several decades and is now the most prominent type of health communication that the public encounters. The FDA regulates DTCPA, but critics say that the rules are too relaxed and inadequately enforced. Although only limited data exist, research suggests that DTCPA is both beneficial and detrimental to the public health. The number of arguments that favor or oppose DTCPA is fairly evenly balanced, and viewpoints presented by both sides can he supported with evidence. Although there have been calls to ban or severely curtail consumer drug advertising, remedies to maximize the benefits and minimize the risks of DTCPA are more frequently suggested.
Prior legislative history
New Legislation
Fiscal implications
EFFECTIVE DATE: This act shall take effect on the one hundred eightieth day after it shall have become a law. Effective immediately, the addition, amendment and/or repeal of any rule or regulation necessary for the implementation of this act on its effective date are authorized to be made and completed on or before such effective date.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.