Posted by Michael Wonder on 04 Jun 2019
FDA to make it easier for doctors to get unapproved cancer drugs for patients
3 June 2019 - Agency will work closely with physicians seeking treatments through its “expanded access” program.
The FDA plans to provide “concierge service” to doctors seeking access to unapproved drugs for cancer patients who have no other treatment options, the agency announced Monday.
The goal is to remove any “perceived hurdles” for physicians who want to use the agency’s “expanded access” program, said Richard Pazdur, director of the agency’s Oncology Center for Excellence.
The pilot program will include Project Facilitate, a new call center run by the agency’s oncology staff to provide a single point of contact for doctors submitting requests to the program. Although the agency has streamlined its expanded-access program in recent years, the process still may seem confusing to doctors who have little experience with it, Pazdur said.
