Press Release


Embargoed Until Contact

March 05, 2015

Sue Ducat
Director of Communications
(301) 841-9962
sducat@projecthope.org

   

Right-To-Try Laws

 

A new policy brief from Health Affairs and the Robert Wood Johnson Foundation looks at so-called Right-to-Try laws. For patients with serious, potentially life-threatening diseases, current federal regulations offer two routes to gain access to experimental drugs not yet approved by the Federal Drug Administration (FDA): participation in a clinical research trial, or, if not possible, applying to the FDA for use of a drug under the expanded access (also known as compassionate use) program. While the FDA has approved nearly all of these applications, the process is widely thought to be overly cumbersome. Since last year, five states have enacted their own Right-to-Try laws, with the aim of giving critically ill patients the treatments they seek. This health policy brief provides background on the federal regulations of expanded access and the recent involvement by many states. 

 

Topics covered in this brief include:

 

      • What's the background and the laws? The brief outlines the US process for experimental drug testing-from the initial Investigational New Drug (IND) application to the different phases of clinical trials. A year ago, the Goldwater Institute, a libertarian think tank, released a policy paper critiquing the FDA's expanded access program, which began in 1987, and proposing model legislation for state governments to adopt. Five states--Colorado, Louisiana, Michigan, Arizona, and Missouri--have passed Right-to-Try laws, and another fifteen have legislation pending. 

      • What's the debate? As the brief explains, criticism of the states' Right-to-Try laws center on two primary concerns: that patients will be exposed to significant harms with no guarantees of benefits; and that broader individual access to experimental therapies could serve to undermine the ongoing clinical research that might eventually support full FDA approval of these drugs. 

      • What's next? Right-to-Try laws have proved to be politically popular. There are likely to be more state laws passed in the current legislative sessions. In late 2014 Congress introduced legislation to evaluate the current process and make recommendations for its improvement. 
 
 
About Health Affairs
 

Health Affairs is the leading journal at the intersection of health, health care, and policy. Published by Project HOPE, the peer-reviewed journal appears each month in print, with additional Web First papers published periodically and health policy briefs published twice monthly at www.healthaffairs.org. Read daily perspectives on Health Affairs Blog. Download weekly Narrative Matters podcasts on iTunes.