Legislative Testimony: “Right to Try” Bill would Nullify in Practice Some FDA Restrictions on Terminal Patients

Following is testimony I offered before the Alaska Senate Health and Social Services Committee in support of “Right to Try” legislation. SB113 would bypass the FDA expanded access program and allow terminally ill 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.

My name is Mike Maharrey and I’m the national communications director for the Tenth Amendment Center.

We’ve been involved with Right to Try almost from the beginning. From the moment we heard about the initiative from the folks at the Goldwater Institute, we knew this was an issue we could support without reservation.

It’s not very often that I would call a piece of legislation a “no-brainer,” but that’s exactly what Right to Try is. Allowing a person to die because of bureaucratic red tape is simply unacceptable. And it doesn’t have to happen. Passage of SB113 will take the decision making process regarding a patient’s treatment options out of the hands of detached officials thousands of miles away and put it where it belongs – with them, their doctors and their families.

According to the president’s Council of Advisers on Science and Technology, the time from the discovery of a drug to its approval has nearly doubled from eight years in the 1960s to roughly 14 today – sometimes longer. Under the expanded access provision of the Federal Food, Drug, and Cosmetic Act patients with serious or immediately life-threatening diseases can access experimental drugs after receiving permission from the FDA. But applying for this exemption requires reams of paperwork, and the agency only approves a handful of applications each year.

As a state Senator, you have within your power to cut through this red tape and create a mechanism that will offer Alaskans a streamlined alternative that could literally mean the difference between life and death.

Like I said – it’s a no-brainer.

This is exactly why our founding-fathers created a system based on Federalism – so that we don’t have to rely on top-down, one-sized-fits-all decision making far removed from the people it affects. We all intuitively understand the dangers of monopoly when it comes to economics. Those same dangers exist in monopoly government. It’s not that the FDA intentionally tries to keep medicine away from sick people. It’s just that this federal agency is overwhelmed and driven by its own institutional pressures. Right to Try is a perfect example of states using their rightful authority to exercise control over local issues. As James Madison wrote in Federalist #45, the realm of state government includes “those objects which, in the ordinary course of affairs, concern the lives, liberties and properties of the people.”

Access to treatments and medications for the desperately ill certainly falls within that category.

As state lawmakers, you can’t solve every problem. But you can solve this one. You have the authority and it’s the right thing to do.

With that in mind, I respectfully ask that you vote yes on HB113.

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