JULY 1, 2015 – Patients faced with life-threatening illnesses have more treatment options open to them in Tennessee and Florida thanks to laws that go into effect today.
These new laws, called Right to Try, effectivel nullify in practice some Food and Drug Administration (FDA) rules that block terminally ill patients from utilizing certain treatments, allowing them to access experimental medications and procedures not yet approved by the federal regulatory agency.
FDA red tape slows access to unapproved treatments, and sometimes blocks it altogether. The Federal Food, Drug, and Cosmetic Act prohibits general access to experimental drugs. However, under the expanded access provision, patients with serious or immediately life-threatening diseases may try experimental drugs and treatments after receiving express FDA approval. These state Right to Try Acts bypass the FDA expanded access program and allow patients to obtain experimental drugs from manufacturers without jumping through the bureaucratic hoops necessary to get federal permission.
Despite directly challenging federal authority, state Right to Try laws stir up very little opposition. Both the Florida and Tennessee acts sailed through their respective legislatures. People intuitively understand understand that FDA regulations that would let a desperately sick patient die rather than try has got to be one 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.”
Rep. Ray Pilon (R-Sarasota), along with nine co-sponsors, introduced the Florida Right to Try Act in January.The bill unanimously passed the House and cleared the Senate 39-1.
In Tennessee Rep. Jon Lundberg (R-Bristol) sponsored The Phil Timp-Amanda Wilcox Right to Try Act, along with 20 cosponsors. The measure sailed through the legislature, unanimously clearing both houses.
Both laws feature provisions that shield health care providers with prohibitions against revoking licenses or issuing sanctions based on their recommendation or issuance of investigational treatments.
These two new Right to Try laws represent an important step toward health freedom. Twenty states have passed similar bills into law, and three more only need a governor’s signature to go into effect.
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.
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