Drug Co-Packaging Proposed Rule Could Hamper Some OTC Marketing

OTC drug packages with separate containers of a product's daytime and nighttime formulations could be mislabeled under US FDA’s proposed rule, as well as co-packaged products with little similarity in use, such as an oral analgesic sold in tandem with a topical pain relief product.

FDA should narrow its proposed definition of “co-packaged” drugs to avoid curtailing OTC firms’ marketing strategy of offering multiple products with similar or different indications in a single package, say industry stakeholders.

A proposed rule published in December 2015 – “Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients...