A while ago we shared a letter from the Healthcare Compliance Packaging Council to FDA regarding an FDA decision out of the Office of Drug Safety “that prohibits generic drug manufacturers from ‘calendarizing’ unit dose blister cards, strips, and other packaging formats.”
We hadn’t heard anything official from FDA, so I asked the agency for an update. Here is the official response, courtesy of two always helpful press contacts, Crystal Rice and Karen Mahoney:
“The Office of Surveillance and Epidemiology evaluates proposed labels and labeling from a medication error perspective. We are not opposed to patient unit-dose packaging. However, we want to ensure that the unit-dose pack is designed in a way that is not confusing to the patient or caregiver and makes sense for the dosage and administration of the product. In certain instances, manufacturers wish to place the days of the week (calendarize) on the unit-dose packaging. However, calendarizing may not be suitable for all medications. For example, medications that are given on an as-needed basis, or once or twice daily, as opposed to those with fixed doses. Thus, we evaluate every proposal on a case-by-case basis to determine if the package design and proposal for calendarization makes sense for the dosage and administration of the product and does not contribute to confusion that could lead to dosing errors.”
The good news is that FDA is not opposed to unit-dose packaging, which could put to rest fears that FDA is banning all generic drug manufacturers from using calendarized packaging if the brand drug maker doesn’t.
But could the case-by-case process for reviewing package design and calendarization proposals make some generic drug makers reluctant to introduce something new?
The rush to market can be fierce. I hope that innovation won’t get trampled.