H.R. 5158: Fair Price Device Act

This bill, titled the Fair Price Device Act, aims to amend the Federal Food, Drug, and Cosmetic Act to facilitate the approval process for combination products that consist of a generic drug and a medical device. Here is a breakdown of its key provisions:

Modifications to Approval Process

The bill proposes changes to the existing regulations regarding the approval of generic drugs that are intended to be used with medical devices. Specifically, it includes the following alterations:

• The term "differences" in the context of required changes due to the use of different devices will be redefined, allowing greater flexibility for manufacturers to make appropriate alterations to their devices without compromising the approval process.
• Additional information must be included in the applications for generic drugs that are designed to work with medical devices. This information should support the argument that the new drug is expected to deliver the same safety and effectiveness as the currently approved listed drug when used with its device.
• The bill emphasizes the need for comparative analyses of both the new drug and the listed drug, including any differences in the user experience and interactions with the device.

Information Requirements

New requirements for information to be included in applications are outlined as follows:

• Comparative and non-comparative information regarding how the new drug performs when used with the medical device.
• Details about the compatibility of the new drug with the existing device, including how the delivery of the new drug might differ.
• Summary data from human factors studies that demonstrate usability and effectiveness when the new drug interacts with the medical device.

Regulatory Oversight

The bill grants the Secretary of Health and Human Services the authority to determine the specific information that must be included in applications. This ensures that the approval process stays aligned with the latest safety and effectiveness standards.

Purpose of the Changes

The primary purpose of these amendments is to provide a clearer path for generic drugs that integrate with medical devices. By modifying the requirements for submissions and enhancing information transparency, the bill aims to streamline the approval process while ensuring patient safety and product efficacy.

Relevant Companies

• PFE (Pfizer Inc.): As a major pharmaceutical company, Pfizer produces both drugs and medical devices, which may lead to significant impacts on its product development and approval timelines.
• BDX (Becton, Dickinson and Company): This company specializes in medical devices and could be directly affected by changes in the approval process of combination products involving their devices and generic drugs.
• AAPL (Apple Inc.): While not a traditional player in pharmaceuticals, Apple's healthcare-related devices may also interact with drug applications, potentially aligning with the regulatory changes proposed.