Patients facing life-threatening illnesses now have more treatment options open to them in Illinois and Oregon thanks to new laws tearing down federal roadblocks that went into effect on New Year’s Day.

These new “Right to Try” laws effectively nullify in practice some Food and Drug Administration (FDA) rules that stop terminally ill patients from utilizing certain treatments, allowing them to access experimental medications and procedures not yet approved by the federal regulatory agency.

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 only after receiving express FDA approval.

These new state laws 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 effectively nullifies it in practice.

Despite directly challenging federal authority, state Right to Try legislation stirs up very little opposition. Bills sailed through their respective legislatures in both Oregon and Illinois. Americans from across the political spectrum intuitively understand that  FDA regulations that let a desperately sick patient die rather than try count among some of the most inhumane policies of the federal government.

In Oregon, the House Interim Committee on Health Care introduced House Bill 2300 (HB2300) last year. The legislation passed unanimously in the House on Apr. 7 by a 59-0 vote. An amended version of the bill then passed unanimously in the Senate on July 1 by a 29-0 vote. The House approved the Senate version of the bill a day later.

In Illinois, Rep. Greg Harris (R-13) and 21 bipartisan co-sponsors introduced House Bill 1335 (HB1335). It passed the House by a 114-1 margin, and then cleared the Senate on May 19 by a unanimous 55-0 vote.

“Americans shouldn’t have to ask the government for permission to try to save their own lives,” Goldwater Institute president Darcy Olsen said. “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.”

Right to Try bills have real impact on real people. The FDA vividly illustrates how the federal government harms countless individuals with its one-size-fits-all policies and soulless bureaucratic processes. State action can break apart the federal monopoly in a way that benefits vulnerable individuals.

These Right to Try laws represent an important step toward health freedom. Twenty-Four states have enacted this legislation, and several more states will take up the issue during the 2016 legislative session.

Although these laws only address one small aspect of FDA regulation, they provide us with a clear model demonstrating how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself. The strategy works because it focuses on ending specific federal policies large numbers of Americans from across the political spectrum oppose.


For other states: Take the steps to get a similar bill passed in your state at THIS LINK.

Mike Maharrey

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