United States 116th Congress Status: Died 1 R cosponsors

HR 6258 — Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020

Last action — Referred to the House Committee on Energy and Commerce.

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  1. ✓
    Introduced
  2. ✓
    In Committee
  3. Died in session

This bill died with 116th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

Summary

Establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country and there is an unmet need. Specifically, the bill requires the product's sponsor to demonstrate, among other things, that their product has been approved in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there is a public health or unmet medical need for the product. The FDA may only decline approval if the FDA determines that the product is not safe or effective. The FDA must make such a determination not later than 30 days after receiving a request. Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.

Bill Text

We don't have the full text on file for this bill yet.

Read HR 6258 on the official United States source →

Action History

  1. Referred to the House Committee on Energy and Commerce.

  2. Introduced in House

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

Health Congressional oversight Drug safety, medical device, and laboratory regulation
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Frequently asked questions

What does HR 6258 do?
Establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country and there is an unmet need. Specifically, the bill requires the product's sponsor to demonstrate, among other things, that their product has been approved in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there is a public health or unmet medical need for the product. The FDA may only decline approval if the FDA determines that the product is not safe or effective. The FDA must make such a determination not later than 30 days after receiving a request. Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.
Who sponsors HR 6258?
HR 6258 is sponsored by Chip Roy (R).
What is the current status of HR 6258?
This bill died with 116th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 6258?
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Last checked for changes about 16 hours ago · updated continuously

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