But the FDA wants to know outcomes for patients taking unapproved drugs

CHICAGO — The FDA says it is making it easier for doctors to access unapproved therapies for cancer patients, but Richard Padzur, MD, is emphatic: the pilot program, called Project Facilitate, only covers drugs in the oncology space.

The FDA decided to unveil the new initiative in an early morning press conference here at the American Society of Clinical Oncology. And although Project Facilitate offers a physician-only portal to identify companies and drugs that are available for expanded access, the agency is partnering with the Reagan-Udall EA Navigator to offer patients a tool to find information on drug makers policies on EA as well as help in “navigating” ClinicalTrials.gov. The advantage to patients is that “we have all the information in one place. There is no need for endless searches,” said Ellen Sigal, PhD of Reagan-Udall.

Padzur said the FDA is requiring patients who participate to report outcomes — all outcomes, including adverse events. “We do need to get this information,” he said. Asked by BreakingMED if the FDA would make that information publicly available or if it would share it with researchers, Padzur said that the information “will be made public, but how that will be done or how the information will be used has not yet been determined.”

Project Facilitate will work like this: the patient’s physician will contact the pharmaceutical company to ask for its agreement that it will provide the product. The company has the right to permit or refuse the request, Padzur said, but the FDA is urging drug makers to participate. The number to call — and Padzur said it is a “live” number — is 1-240-402-0004. And the email address is OncProjectFacilitate@fda.hhs.gov.


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