FDA Notes Manufacturer Participation in Right to Try Act May Be Limited

It’s been four years since the Trump administration’s Right to Try Act was signed into law, but the benefits have yet to be quantified. The US law allows patients with serious illness and limited treatment options to apply to take experimental therapeutics or those not indicated for their disease. Although the Food and Drug Administration is in charge of the law’s implementation, the agency is not part of the application approval process and does not receive all the information from manufacturers it needs to assess outcomes.

According to Zachary Brennan, “The benefits of this rule consist of societal and public health outcomes that may accrue from the disclosure of the use of investigational drugs and any known serious adverse events provided in these annual summary reports. There is no data that would allow us to predict the magnitude of generated benefits, and thus we are unable to quantify the expected benefits of this rule.”

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(Source: Endpoints News, September 13^th, 2022)