[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5480 Introduced in House (IH)]

<DOC>






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.
                                 <all>