(July 1, 2016) – Today, laws went into effect in three states that set the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.

Maine, Idaho and Georgia legislatures all passed Right to Try bills this year. The new laws enable terminally ill patients to access to medications and treatments not yet given final approval for use by the FDA.

Maine state Rep. Thomas Longstaff (D-Waterville) introduced House Bill 180 (LD180) last year, and the bill was carried over to the 2016 session, The House gave final approval to the legislation 114-28. The Senate concurred the following day by a 20-11 margin.

The Idaho House of Delegates Health and Welfare Committee introduced House Bill 481 (H481) on Feb. 12. The House passed it by a vote of 66-1 and the Senate by a 34-1 vote.

Georgia state Rep. Mike Dudgeon (R-Johns Creek) introduced House Bill 34 (HB34). The Senate unanimously passed the bill 55-0. on March 11. The House also unanimously approved the measure 173-0.

The Federal Food, Drug, and Cosmetic Act prohibits general access to experimental drugs. However, under the expanded access provision of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb, patients with serious or immediately life-threatening diseases may access experimental drugs after receiving express FDA approval.

The new laws create a process to bypass the FDA expanded access program and allow patients to obtain experimental drugs from manufacturers without first obtaining FDA approval. This procedure directly conflicts with the federal expanded access program and sets the stage to nullify it in practice.

The new laws also feature protections for health care providers with prohibitions against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments, as well as prohibiting lawsuits against physicians who comply with the law. Manufacturers of treatments will enjoy similar protections.

“Americans shouldn’t have to ask the government for permission to try to save their own lives,” said Darcy Olsen, president of the Goldwater Institute. “They should be able to work with their doctors directly to decide what potentially life-saving treatments they are willing to try. This is exactly what Right To Try does.”

Although these type of bills only address one small aspect of FDA regulation, they provide a clear model that demonstrates how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself, which has proven to be very effective.

More that two-dozen states have approved Right to Try legislation. The momentum has built very quickly behind this idea, with most of these states passing these laws within the past year alone. This rapid progress shows that Americans from across the political spectrum intuitively understand that these FDA regulations are harmful and must be mitigated through state-level action.

Mike Maharrey

The 10th Amendment

“The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.”



Featured Articles

On the Constitution, history, the founders, and analysis of current events.

featured articles


Tenther Blog and News

Nullification news, quick takes, history, interviews, podcasts and much more.

tenther blog


State of the Nullification Movement

232 pages. History, constitutionality, and application today.

get the report


Path to Liberty

Our flagship podcast. Michael Boldin on the constitution, history, and strategy for liberty today

path to liberty


Maharrey Minute

The title says it all. Mike Maharrey with a 1 minute take on issues under a 10th Amendment lens. maharrey minute

Tenther Essentials

2-4 minute videos on key Constitutional issues - history, and application today


Join TAC, Support Liberty!

Nothing helps us get the job done more than the financial support of our members, from just $2/month!



The 10th Amendment

History, meaning, and purpose - the "Foundation of the Constitution."

10th Amendment



Get an overview of the principles, background, and application in history - and today.