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FDA Pledges to Streamline ‘Compassionate Use’ Process in Response to ‘Right To Try’ Laws

February 5, 2015

Washington—Today the Food and Drug Administration announced its intent to streamline the arduous application process for “compassionate use,” a program that allows select patients to use investigational medications before they are available on pharmacy shelves. The process currently requires an application that takes doctors 100 hours to fill out before the FDA can even consider the request. The new form will be shorter, but the rest of the FDA process will remain in place.

Last year, five states passed “Right To Try” laws giving terminally ill patients the right to try investigational medications. Twenty-six more states have introduced similar legislation this year.

Darcy Olsen, president of the Goldwater Institute, the non-partisan organization leading the national campaign for Right To Try laws, issued the following statement in response to the FDA announcement:

The tsunami in the states is working. A bureaucratic agency that has resisted change for decades is finally getting the message: Patients shouldn’t have to beg the government for permission to try to save their own lives.

“Compassionate use” should be the law of the land, not the exception. Regrettably, a “simpler form” is window dressing on an archaic and inhumane system that prevents the vast majority of Americans with terminal illnesses from accessing promising investigational treatments. Patients must still beg the federal government for permission to try to save their own lives—it’s just a shorter form.

Right to Try laws give all patients with terminal illnesses the right to try investigational medicines. Right to Try laws remove barriers that limit medical practitioners from providing care they are trained to give and put access to care for terminally ill patients in the hands of patients and their doctors.

Read more about Right To Try here.




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