This bill (S. 204) would allow patients with life-threatening diseases or conditions who are not participating in clinical trials to seek access to experimental and investigational drugs directly from a drug manufacturer, without approval by the Food and Drug Administration. It would require that in order for the patient to be eligible, the patient must first try all approved treatment options and be unable to participate in a clinical trial. Only drugs that have completed phase 1 clinical trials, that have not been approved or licensed for any use, and that are currently under an active FDA application or are undergoing clinical trials would be eligible for use under the bill’s provisions.
The House passed S. 204 on May 22, 2018 by a vote of 250 to 169 (Roll Call 214). We have assigned pluses to the yeas because the federal government, under the Constitution, has not been given authority over what medical procedures U.S. citizens choose to engage in. If a person wants to try an “unapproved” treatment, he should be able to do so with no interference from the government. In fact, since the Constitution gives the federal government no authority whatsoever over any aspect of healthcare, the FDA should not even exist. Any law that lessens government overreach into the personal medical decisions of citizens is a step in the right direction.
