House to Revive 'Right-to-Try' Bill Next Week, Passage Expected

Posted 16 March 2018 | By Zachary Brennan 

House to Revive 'Right-to-Try' Bill Next Week, Passage Expected

The US House of Representatives’ Rules committee on Monday will take up the same “Right-to-try” bill that failed earlier this week. The bill is expected to easily move through the House, as it will only need a simple majority to pass.

The bill’s likely passage means there will be an alternative pathway whereby patients with terminal illnesses can ask biopharma companies to access experimental treatments that have progressed past Phase I trials, and outside FDA’s purview. New reporting requirements on how many patients are accessing these investigational drugs outside of trials will also be introduced for biopharma companies.

The bill failed to muster two-thirds of the House’s votes, which was necessary for passage Tuesday evening, though Republican House leaders pledged to move the bill forward.

However, the bill will still have to go back to the Senate, which previously passed a different version of the bill last August.

Critics of both bills, including academics, industry leaders and former FDA Commissioner Rob Califf, have said that Right-to-try legislation is a solution in need of a problem, as FDA approves more than 99% of all expanded access requests, enabling those with terminal illnesses to access investigational treatments that companies allow.

Proponents of the legislation, however, say that those with terminal illnesses should be allowed to ask companies to access experimental drugs, and if allowed, access them without FDA oversight, though the House bill would still require companies to report adverse events to FDA.

House Rules Committee

Categories: Regulatory News

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