FDA promises new compassionate use form will save physicians time

Physicians will have to fill out a new form to request access to investigational drugs for patients with terminal illnesses, which the Food and Drug Administration said will be easier to complete, taking 45 minutes.

The goal is to simplify the application process after complaints that the amount of paperwork required for the existing form, labeled Form FDA 1571, may deter patients and doctors from making a compassionate use request. FDA Commissioner Robert Califf, MD, said the new form, known as Form FDA 3926, is much shorter and unique to compassionate use requests.

“As a physician, I understand the importance of being able to access investigational treatments for a patient when there are no other options to treat their serious disease or condition,” Califf said in a statement. “Access to investigational treatments requires the active cooperation of the FDA, industry and health care professionals in order to be successful. But we know that navigating that process can be challenging and time consuming, and we are committed to reducing the procedural burdens on physicians and patients whenever possible.”

Access to experimental drugs has become a popular legislative topic in states in recent years, with 28 states passing so-called “right-to-try” laws, along with efforts from Congress to pass a federal version or prevent the FDA from restricting access to experimental treatments in those states.

Along with the new form, the FDA has released two guidance documents on compassionate use, one explaining what forms are used for individual patient submissions and outlining the appropriate circumstances for making the requests, and the other explaining how patients can be charged for investigational drugs after their requests are approved.