Senate Committee Tackles Right to Try Issue for Terminally Ill Patients

February 29, 2016

In advance of a hearing last week, a Senate committee pressed the FDA to provide information on its expanded access program for drugs.

In a letter to FDA Acting Commissioner Stephen Ostroff,  Senate Committee on Homeland Security and Governmental Affairs Chairman Sen. Ron Johnson (R-Wis.) and Ranking Member Sen. Thomas Carper (D-Del.) note that a February 2015 draft guidance that would allow physicians to prescribe investigational treatments to terminally ill patients has yet to be implemented.

The centerpiece of the process is a new Form 3926 that requires responses to eight questions that provide information about patients, their condition and prior treatments, and the name and treatment plan of the investigational drug.