Biography
Biography: David Vulcano
Abstract
Over the past several years there has been a resurgence of efforts to gain access to investigational products outside of clinical trials. Previously failed attempts a decade or so ago at the federal judicial level has turned advocates’ strategy to pushing states to pass variants of so-called “Right To Try” laws in an effort to circumvent the FDA’s Expanded Access policies. Over the past several years, a majority of states have now done so. While ethicists debate the battle of the good vs. the good of this kind of access, and lawyers debate the state’s rights to have these kind of laws, the FDA and the advocates debate their respective track records. Nevertheless, the issue has gotten the attention of the federal legislators through passed acts (evidenced by certain section in the 21st Century Cures Act) as well as putting forth proposed legislation for a national Right To Try Act. With the current congress and the executive branch leaning towards the advocates’ position, it is likely that we will see continued movement. This session provides a comparison of the varying state “Right To Try” laws and summaries of the most recently passed and proposed federal laws related to this topic.