FDA pilot program aims to boost patient access to unapproved cancer drugs

The FDA is launching a pilot project to make it easier for physicians to get unapproved cancer drugs for their patients, the agency announced June 3.

The program will provide a "concierge service" to physicians. The goal is to remove any perceived hurdles to accessing unapproved medication for patients.

Included in the program is a new call center dubbed Project Facilitate, a single point of contact where FDA oncology staff will help physicians submit requests to allow individual cancer patients to try unapproved drugs.

Although the FDA has streamlined its expanded access program in recent years, the request form still may seem confusing or burdensome to some physicians, according to acting FDA commissioner Ned Sharpless, MD.

"Today's launch of Project Facilitate is part of our continued commitment to expanded access, and we hope that this pilot program will simplify the process for oncologists, and ultimately benefit patients," said Dr. Sharpless.

Read the full news release here.

More articles on pharmacy:
Viewpoint: The $2.1M drug price record won't last long
J&J to cut 61 jobs in New Jersey
Mallinckrodt to spin off generics unit

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

 

Top 40 Articles from the Past 6 Months