H.R. 1632: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025

This bill, titled the "Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025," seeks to amend the Federal Food, Drug, and Cosmetic Act to streamline the marketing approval process for certain drugs, biological products, and medical devices that are already authorized for sale in other countries. Here’s a breakdown of what the bill would do:

Reciprocal Marketing Approval

The bill establishes a system where products that are legally marketed in certain foreign countries (including those on a specific U.S. list and the United Kingdom) can receive reciprocal marketing approval in the United States. This means that:

• If a company wishes to market a product in the U.S. and it is already approved in the referenced countries, the approval process can be expedited.
• The U.S. Secretary of Health and Human Services can grant this approval if the company meets specific requirements, such as demonstrating that the product is safe, effective, and necessary for public health.

Eligibility Criteria for Approval

The Secretary will grant reciprocal marketing approval if the request shows that:

• The product has been authorized for sale in the recognized countries.
• The product would not be approved for marketing in the U.S. without this provision.
• No safety concerns have led to a withdrawal of approval in either the U.S. or the foreign countries.
• The product is not categorized as a banned device in the U.S.
• There is an unmet medical need for the product in the U.S.

Safety and Effectiveness Considerations

The Secretary of Health and Human Services holds the authority to deny reciprocal marketing approval if it is determined that the product is unsafe or ineffective. However, approval can also be conditioned on the need for additional studies after the product is marketed.

Request Process and Timeline

When a company submits a request for reciprocal marketing approval, it must:

• Follow the designated format and include all necessary information.
• Provide translations of marketing authorization documents from the foreign countries.

The Secretary is required to respond to these requests within 30 days.

Labeling and Device Classification

During the approval process, the company and the Secretary will negotiate the product's labels, ensuring they meet U.S. standards. This includes classifying medical devices that receive approval under this act.

Congressional Oversight

If the Secretary denies approval, there is a process for Congress to issue a disapproval resolution that could override the Secretary's decision.

Outreach Efforts

The bill mandates that the Secretary conduct outreach to encourage companies with eligible products to seek reciprocal marketing approval.

Definition of Covered Product

For the purposes of this legislation, a "covered product" includes drugs, biological products, and medical devices that meet the specified criteria for reciprocal marketing approval.

Relevant Companies

None found