Industry Calls for Clarification on Labeling Guidance

Nearly a dozen organizations are calling for clarification on a draft FDA plan to label injectable therapies that are meant to be used multiple times by a single patient as products for “single patient–use.”

Intended to help cut down on the number of patient-to-patient blood-borne infections, the Oct. 21 draft guidance says current package terms fail to make clear that multiple use containers — including insulin pens — should only be used on one patient.

To that end, the FDA revised its definitions for “single-dose” and “multiple-dose” and added the new single patient–use term to eliminate confusion about each type of container’s intended use.

While many commenters agree that a different package descriptor is needed for injectable drug containers, they also question the agency’s determination of what constitutes “single dose” or “single patient–use.” Many write that clinicians and patients might easily misinterpret the FDA’s word choices. 

“[W]e are concerned about the use of single dose to describe all packages which are designed to be used once and discarded,” says Robert B. Clarke, VP of regulatory affairs for Novo Nordisk. If a container or carton is labeled “single dose,” a patient might mistakenly believe that the contents of that container represents a full dose, “leading to a significant risk of under-dosing.”

Michael R. Cohen, president of the Institute for Safe Medical Practices, says he supports the creation of a single patient–use container to describe a package intended for an individual patient. However, he opposes using “single dose,” saying such language is “considered ambiguous by some practitioners and may lead to unintentional overdoses.”

Christopher J. Topoleski, director of federal legislative affairs for the American Society of Health System Pharmacists, warns against replacing the term “single-use” with “single patient–use,” as the latter term also applies to a “single-dose container.”

While applauding the agency’s efforts, Victoria A. Dohnal, manager of science and regulatory affairs at BIO, says the document needs to be reworked.

Dohnal suggests that the FDA include in the guidance a “label example for each package type term (single-dose container, multiple-dose container and single patient-use container) and space permitting, the appropriate discard statement for each.”

Many of the commentators write that the FDA should consider getting input from other agencies, such as the CDC, “to explore other terms or visual cues, such as symbols or pictograms, to communicate the appropriate use of the container,” writes Topoleski.