Patient-Compliant Packaging Hits a Regulatory Snag

FDA denies use of ‘calendarizing’ features when added to an ANDA


In an apparent by-the-book regulatory decision, FDA’s Office of Generic Drugs has denied an application by an unspecified generics manufacturer to add calendar features to blister-card packaging in a drug-approval filing. That prompted discussions with the Labeling and Program Support department in FDA and the Healthcare Compliance Packaging Council (Alexandria, VA), a trade group that promotes use of unit-dose packaging and patient-compliance enhancements of pharma packaging. But the ruling stands unless a regulatory change is legislated.

According to HCPC, FDA ruled that unless the calendar feature was part of the original NDA application (and approved), it couldn’t be added to the follow-on generic ANDA. Some packaging changes can be performed as “minor changes” to an existing approval (as reported by the brand owner annually); this one apparently cannot.

Non-approval of a feature like adding date reminders to a blister card probably won’t keep a generic drug off the market, but does kick the legs out from one of the longstanding (and well documented) beliefs of HCPC and packaging designers: that using blister cards instead of a bottle of pills, and adding reminder features to the card, improve overall patient adherence. Patients can easily see if they have already taken Tuesday’s pill, for example, because the cavity for that dose is empty.

Proponents of compliance packaging will either have to get more brand owners to use the technology, convince generic manufacturers to expand their drug applications, or get a change legislated in Congress. PC