ALS Placebo No More Act

I 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘ALS Placebo No More 4 Act’’. 5 SEC. 2. AUTHORITY FOR HHS AND AGENCIES TO DEVELOP 6 RESOURCES AND POLICIES TO PROVIDE AC- 7 CESS TO PROMISING TREATMENTS FOR PA- 8 TIENTS WITH ALS. 9 The Food and Drug Administration (FDA) and the 10 National Institutes of Health (NIH) shall collaborate on 11 VerDate Sep 11 2014 19:57 Jan 06, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5480.IH H5480 lotter on DSKBCFDHB2PROD with BILLS 2 •HR 5480 IH any current amyotrophic lateral sclerosis (ALS) trial to 1 ensure that all patients in treatment and placebo arms are 2 provided access to the drug. 3 The FDA shall move expeditiously to implement its 4 guidance on ALS clinical trials to assure that all trials 5 going forward shall require treatment arms for all pa- 6 tients. 7 The Federal Government shall develop incentives to 8 expand access to investigational therapies for life-threat- 9 ening conditions with fewer than two treatments. 10 Æ VerDate Sep 11 2014 19:57 Jan 06, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\H5480.IH H5480 lotter on DSKBCFDHB2PROD with BILLS