Under FDA’s expanded access program, FDA approves almost all requests it receives to provide patients access to investigational products (not yet approved for any indication) outside of a clinical trial (also called “compassionate use”). However, some complain that FDA’s current system is too burdensome and difficult to navigate. Although FDA is streamlining its process, states are looking at and passing Right-to-Try bills modeled on template legislation drafted by the Goldwater Institute.
Currently, 24 states have enacted Right-to-Try laws, and in another 24 states and the District of Columbia, Right-to-Try bills have either been introduced or passed. While individual state bills contain varied provisions, most define eligible patients as having a terminal illness and provide protections for physicians, providers, and manufacturers that make an investigational drug available. Although designed to help patients, the lack of FDA and Institutional Review Board (IRB) oversight through the Right-to-Try pathway reduces patient protections compared to FDA’s expanded access program. In addition, given that these Right-to-Try laws do not require manufacturers to provide access to their investigational products, it is unclear how Right-to-Try will be more successful than FDA’s expanded access program at enabling patients to access drugs from manufacturers.
The following map illustrates the states that have introduced Right-to-Try bills or enacted Right-to-Try laws. For more information on preapproval access/compassionate use, please see Avalere webinars here and here.
If you have questions about Right-to-Try laws, please contact Brenda Huneycutt at BHuneycutt@avalere.com.