Text: H.R.5480 — 116th Congress (2019-2020)All Information (Except Text)

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Introduced in House (12/18/2019)


116th CONGRESS
1st Session
H. R. 5480


To ensure that ALS patients have access to treatment within clinical trials.


IN THE HOUSE OF REPRESENTATIVES

December 18, 2019

Mr. Fortenberry introduced the following bill; which was referred to the Committee on Energy and Commerce


A BILL

To ensure that ALS patients have access to treatment within clinical trials.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. Short title.

This Act may be cited as the “ALS Placebo No More Act”.

SEC. 2. Authority for HHS and agencies to develop resources and policies to provide access to promising treatments for patients with ALS.

The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) shall collaborate on any current amyotrophic lateral sclerosis (ALS) trial to ensure that all patients in treatment and placebo arms are provided access to the drug.

The FDA shall move expeditiously to implement its guidance on ALS clinical trials to assure that all trials going forward shall require treatment arms for all patients.

The Federal Government shall develop incentives to expand access to investigational therapies for life-threatening conditions with fewer than two treatments.


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