(July 29, 2015) – Patients facing life-threatening illnesses will have more treatment options open to them in Alabama, North Dakota and Minnesota on Saturday thanks to new laws that tear down federal roadblocks going into effect this week.

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 after receiving express FDA approval.

These new state laws bypass the FDA expanded access program and allows 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 laws stir up very little opposition. Right to Try bills sailed through their respective legislatures in Alabama, North Dakota and Minnesota. 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.

“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.”

Alabama Sen. Cam Ward (R-Alabaster) sponsored Senate Bill 357 (SB357) along with five cosponsors. The Gabe’s Right to Try Act unanimously passed both the Alabama House and Senate.

Gabe Griffin inspired the legislation. The 10-year-old boy suffers from Duchenne Muscular Dystrophy, a rare, debilitating condition with a 100 percent mortality rate to date. Gabe’s parents say they hope the new law will give their son a new lease on life.

“At 10 years old, Gabe walks, hugs, breathes, and feeds himself like any other typical child that age, but that will be taken away in the next few years if we don’t find a cure,” Gabe’s father, Scott Griffin, said during a WTVY interview. “Without a cure, Gabe is expected by doctors to be in a wheelchair by the time he is 12 years old and lose his life around the age of 20. Traci and I are willing to accept all risks to save our son and we will do anything to keep from having to put him in a wheelchair in a couple of years.”

Sen. Tim Mathern (D), along with five cosponsors, introduced the North Dakota Right to Try Act (SB2259). It cleared the state Senate 32-15, and breezed unanimously through House with a 91-0 vote.

A Minnesota right to try bill also sailed through the legislative process, passing the state Senate 60-4 and gaining overwhelming House approval 123-0. Rep. Nick Zerwas served as one of the bill sponsors. On the House floor, he shared a story about his own experience with experimental medical procedures. As a 15-year-old, Zerwas learned he would not be getting a needed heart transplant. Doctors told he only had a few months to live, but suggested an experimental heart surgery.

“That was my right to try,” he said. “I fully believe life is worth fighting for, and government has no role in getting in the way.”

Clearly, 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-two states have passed similar legislation into law, and bills in Illinois and Oregon only need their respective governors’ signatures.

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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