United States 114th Congress Status: Died 1 R cosponsors

HR 2415 — To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program.

Last action — Referred to the Subcommittee on Health.

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

This bill died with 114th 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This bill is no longer active — its legislative session has ended, so there is no live prognosis.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

To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program. This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a streamlined data review program under which the holder of an approved application for a drug or biological product may submit a summary of clinical data to support approval of the drug for the treatment of cancer or another indication subject to the program. For a drug to be eligible for the streamlined data review program there must be a database regarding the safety of the drug and the full data sets used to develop the data summaries must be submitted, unless the FDA determines that the full data sets are not required. The FDA must annually publish: (1) the number of applications reviewed under the streamlined data review program, (2) the average time for completion of review under the streamlined data review program compared to review of other applications for new indications, and (3) the number of applications reviewed under the streamlined data review program for which the FDA made use of full data sets.

Bill Text

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

Read HR 2415 on the official United States source →

Action History

  1. Referred to the Subcommittee on Health.

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

  3. 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

healthcare health-insurance
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Frequently asked questions

What does HR 2415 do?
To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program. This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a streamlined data review program under which the holder of an approved application for a drug or biological product may submit a summary of clinical data to support approval of the drug for the treatment of cancer or another indication subject to the program. For a drug to be eligible for the streamlined data review program there must be a database regarding the safety of the drug and the full data sets used to develop the data summaries must be submitted, unless the FDA determines that the full data sets are not required. The FDA must annually publish: (1) the number of applications reviewed under the streamlined data review program, (2) the average time for completion of review under the streamlined data review program compared to review of other applications for new indications, and (3) the number of applications reviewed under the streamlined data review program for which the FDA made use of full data sets.
Who sponsors HR 2415?
HR 2415 is sponsored by Michael Burgess (R).
What is the current status of HR 2415?
This bill died with 114th 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 2415?
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