The Wisconsin Medical Society on Wednesday urged a state legislative committee to amend proposed legislation that would create a process for patients to access experimental drugs outside the U.S. Food and Drug Administration’s (FDA) research and approval process. Called “Right to Try,” Senate Bill 84/Assembly Bill 69 would allow patients to access experimental drugs that have passed a Phase 1 clinical trial, but have not necessarily progressed further. The bills received a public hearing before the State Senate Committee on Health and Human Services.
The Society’s testimony highlighted recent action taken on Right to Try legislation in the U.S. Senate, where a substitute amendment altered the federal version from a “carve out” from the FDA process to instead establishing an additional path within the FDA’s purview. The federal amendment—which passed unanimously on August 3—would require that a patient have “exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug” before becoming eligible to participate in the Right to Try procedure.
This important provision helps protect the incentive for patients to participate in a clinical trial, which offers the best scientific procedure for developing the most effective, safest drugs. The federal bill also requires that the FDA collect data related to a patient’s use of an experimental drug, and that the FDA issue an annual report on usage, outcomes and other important information. These provisions are absent in the state’s version of Right to Try; therefore, the Society urged the committee to amend the state bill to mirror the elements now contained in the federal counterpart.
The Society has offered to work with legislative authors on reasonable amendments to the bill to ensure patient protections and maximized chances for scientific advancement. Contact Mark Grapentine, JD, in the Society’s Government Relations Department for more information.
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