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Friday, May 22, 2015

Expansion of ‘Right to Try’ legislation raises ethical, safety concerns

By HemOnc Today
Originally published April 25, 2015

Early access to experimental drugs has historically been reserved for patients enrolled on clinical trials.

In 2009, the FDA revamped its 1980’s expanded access program, which allows terminally ill patients ineligible for clinical trials and for whom no alternative, approved therapies exist to ask pharmaceutical companies for access to an investigational drug in their pipeline. More than 1,500 patients received an experimental treatment through the FDA’s program in 2014.

Now, some legislatures are going a step further by adopting so-called “Right to Try” legislation, intended to give terminally ill patients comparable access to investigational drugs but removing the FDA from the process.

Since 2014, thirteen states have passed Right to Try laws, and legislators in 20 more states have plans to introduce similar legislation this year.

The entire article is here.