The debate over expanded access is heating up again, folks!

My colleague Matt Herper sat down yesterday with Dr. Richard Pazdur, the director of FDA’s Oncology Center of Excellence, to discuss a new agency initiative that is intended to make it easier for physicians to request access to experimental cancer treatments. Don’t get too excited: It largely builds on the FDA’s existing expanded access pathway, whereby doctors can request the FDA’s go-ahead to give patients unapproved drugs, so long as the drug makers developing those drugs have also agreed to the plan. Under the FDA’s new pilot plan, the agency will launch a call center staffed by the FDA’s oncology experts that will answer doctors’ questions and even help with the requisite paperwork. Changing the expanded access process has been a goal of Pazdur for years, he told Matt. “I think this is a more equitable process,” he added.

And in case you missed it, I have a new story out about one patient’s efforts to speed up the FDA’s expanded access process — a crusade that even led them to enlist a striking coalition of lawmakers to pressure the FDA. The piece examines all the ethical issues that pop up when lawmakers start trying to pressure a government agency on a single patient’s behalf.