H.R. 5480 — Introduced in House

I 116th CONGRESS 1st Session H. R. 5480 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. 1. Short title This Act may be cited as the ALS Placebo No More Act. 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.