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"Right-to-Try" Legislation Defeated in House Amid Doubts About Its Necessity

Allison Inserro
A revamped “right-to-try” bill was defeated in the House of Representatives 259-140 Tuesday night. Advocates had said the bill would give desperate, dying patients a last chance at experimental treatments. Earlier, The American Journal of Managed Care® sought reaction from Marjorie A. Speers, PhD, executive director of the WCG Foundation, a public charity which works to ensure experimental medicines to very ill patients under the FDA's current expanded access and compassionate use programs.
At the same time, Speers noted, “This bill removes FDA but it seems to me…by trying to keep some of the restrictions, limitations on these uses, it’s an implicit acknowledgement that the current FDA’s expanded access program works.”

In states that do have right-to-try laws, they are not being used much for several reasons, she said. “Patients, physicians, and product manufacturers, they don’t want to go outside of the clinical trials process. They don’t want to go outside the regulations that seem to be working."

“This bill really doesn’t fix a problem, because the problem it’s intended to fix doesn’t exist,” Speers said, noting that the FDA streamlined the application for expedited access in 2016 and overall has been more responsive.

Another value of the FDA reviewing this process, she said, is that when an application is filed, an IND number is given and a letter sent to the physician. Sometimes, she said, that FDA letter will include suggestions, perhaps having to do with monitoring, doses, or administration. It is information helpful to the physician, the IRB, and also the patient, thus improving patient care. None of that is included in the House bill being considered today, she said.

“This formal review process can be invaluable to patients,” she said.

Patient groups remained unconvinced about the bill as well—75 of them sent a letter Monday to House Speaker Paul Ryan, R-Wisconsin, and Minority Leader Nancy Pelosi, D-California, saying the changes do not go far enough.

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