Texas House Bill HB3455

Texas 2025 - 89th Regular

• Filed: 2/27/25

Caption

Relating to manufacturer disclosure requirements and liability for experimental drugs and devices.

Impact

The bill will significantly impact the Health and Safety Code, specifically through the addition of Section 431.118. This section outlines the obligations of manufacturers to furnish consumers with necessary information about their drugs and devices, thereby increasing transparency and accountability in the pharmaceutical and medical device sectors. Additionally, it allows consumers the right to seek damages for issues arising from non-compliance, which in turn might compel manufacturers to adhere strictly to these disclosure requirements.

Summary

House Bill 3455 introduces specific disclosure requirements for manufacturers of experimental drugs and devices. The legislation mandates that any manufacturer must provide clear and coherent information regarding any experimental drugs or devices, including potential adverse health effects. This aims to ensure consumers are adequately informed before deciding to use these products. The bill also establishes legal grounds for consumers to take action against manufacturers whose experimental products cause adverse effects.

Contention

One key point of contention potentially arising from HB3455 is regarding the balance between consumer protection and the responsibilities placed on manufacturers. Manufacturers may view the requirement for extensive disclosures and liability as overly burdensome, which could hinder innovation in the development of new drugs and devices. On the other hand, advocates for the bill argue that consumers deserve comprehensive information to make informed choices, especially when it comes to experimental medical products.

Texas Constitutional Statutes Affected

Health And Safety Code

• Chapter 431. Texas Food, Drug, And Cosmetic Act
  • Section: New Section