ASHP, Partners Defend Clinicians' Ability to Provide Evidence-Based Off-Label Care

ASHP and more than a dozen medical professional societies and patient advocacy organizations filed amicus briefs urging courts to reject the U.S. Department of Justice’s (DOJ) argument that off-label use of a medication amounts to introducing a misbranded drug into the supply chain in violation of the Federal Food, Drug, and Cosmetic Act.

The federal government's argument could expose hospitals, pharmacists, and other healthcare providers to liability for routinely dispensing or administering medications approved by the Food and Drug Administration (FDA) for medically appropriate off-label uses.

The briefs explain that off-label prescribing is often the standard of care across numerous specialties, and is particularly critical for patient populations that are frequently excluded from clinical trials, such as children, pregnant patients, older adults, and individuals with rare diseases. The government's position could jeopardize access to evidence-based treatments for patients who have few or no FDA-labeled therapeutic options. Further, the briefs note the DOJ’s arguments conflict with Medicare’s own coverage policies for medically accepted off-label uses.

“ASHP has clear policy supporting safe off-label use of medications,” said Tom Kraus, ASHP chief advocacy officer and vice president of government relations. “Arbitrary limitations on off-label use will seriously jeopardize care for patients across specialties and regardless of demographics.”

While DOJ's arguments stem from an investigation of gender-affirming care at hospitals, they have broad implications for any and all off-label use of medications.

ASHP will continue working with coalition partners to defend pharmacists' ability to provide evidence-based patient care.