FDA Has Issued Documents Aimed at Guiding the Selection of Proprietary Names for Drugs

The US Food and Drug Administration (FDA) has issued a pair of draft guidance documents aimed at guiding the selection of proprietary names for prescription and non-prescription drugs.

The best practices set forth in the guidances are designed “to help minimize proprietary name-related medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations,” according to the guidances.

The best practices documents apply only to human drugs; the non-prescription drug naming guidance runs to 17 pages, whereas the guidance dedicated to prescription drug naming is 42 pages long and includes appendices outlining research methodology considerations for conducting misbranding review and name simulation studies. The prescription drug guidance also includes high- and low-similarity name pair lists and a checklist for moderately similar name pairs.

The prescription medication naming guidance lays out FDA’s thinking about how to prescreen proposed proprietary names for attributes that contribute to medication errors. These include avoiding obvious similarities in spelling or pronunciation, as well as avoiding listing inert of inactive ingredients as co-equal with active ingredients and avoiding the omission of active ingredient(s) when two or more are present.

Both guidance documents also recommend against incorporating the sponsor’s name in a proprietary name, since it increases the likelihood of confusion between different medications that may be quite similar.

The non-prescription naming guidance gives specific recommendations for how to handle any name changes for drug products that are being switched from prescription to non-prescription use.

The guidances also detail how FDA uses its POCA software to “evaluated the orthographic and phonetic similarity of a proposed proprietary name to other names.” POCA evaluations may be conducted by the sponsor, but regardless of whether a submission includes a POCA evaluation, FDA will still conduct its own.

In part, the agency conducts an independent POCA review since pending products’ proprietary names may be confidential and not accessible to another sponsor. The POCA score of 55% for orthographic and phonetic searches is FDA’s cutoff for acceptable similarity.

Moderately similar name pairs need further evaluation, according to the guidances. Name attributes, such as the first several letters of a drug name, can contribute to name confusion. Similarly, product attributes can also come into play: “Moderately similar name pairs of products that have overlapping or similar strengths or doses represent an area of concern to FDA,” wrote the agency.

Source