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Experimental Drug Access Programs Risky for Drugmakers

June 8, 2018, 8:25 PM

Experimental drug access programs could delay drug approvals by diverting drugmakers’ attention from clinical trials and possibly scaring off trial participants, according to a bioethicist and drugmaker executives.

That’s just one of the risks drugmakers must consider before offering early access programs, the officials and bioethicist said at the Biotechnology Innovation Organization’s annual conference. The need to establish clear policies and stick to them is more important than ever after President Donald Trump signed into law a new right-to-try bill he repeatedly championed. The FDA’s separate expanded access, or compassionate use, program also remains as an alternative way patients can...

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