Objections Raised on Co-Packaged Drugs Guidance
The Personal Care Products Council says that while it supports the FDA intent to harmonize requirements for prescription and OTC products and make them consistent with long-standing agency policy, it has some concerns about the agency’s proposed rule on fixed-combination and co-packaged drugs covering applications for approval and combinations of active ingredients under consideration for inclusion in an over-the-counter monograph. An identical comment letter was submitted by the Consumer Healthcare Products Association.
The letters say that since prescription and OTC drugs have a number of differences, the groups are “concerned that FDA’s proposed definition of and use of the term ‘co-packaged drug’ in this proposed rule could cause significant confusion within industry and among consumers regarding what OTC products are covered by the proposed requirements, given FDA’s proposed definition of co-packaged is substantially different from that used every day by consumers and in commerce.”
The associations say that they don’t agree with FDA’s conclusion that the act of packaging two drug products together inherently means that the two drug products are intended to be used together absent specific labeling language to the contrary. They also say that under the agency’s proposed presumptions that drug products packaged together are intended to be used together, they are concerned that each example term that could be used in labeling to overcome the presumption (such as “value” or “travel”) must be cited in the regulation for the product to be exempt. “While we can generate a list of terms used today, such as family pack, bonus pack, convenience pack, free sample, first aid,” they say, “there could be many other terms used in the future that are also acceptable but not clearly addressed in the preamble.”
The two associations ask FDA to consider using a more specific term or definition to describe the subject of co-packaged drug products that would be subject to the proposed requirement, so that interested parties will not be confused about the term’s scope when it is used in other contexts. They also ask the agency to explicitly state in its regulatory definitions that drug products that are packaged together are only subject to the rule’s requirements if their packaging or labeling affirmatively indicates that the products are intended to be used together.
In its comment letter, Bayer says it agrees with the points made by the Consumer Healthcare Products Association and says that the propose definition of co-packaged drug is overly broad and could lead to consumer confusion.