PhRMA Proposes “Early Review” System for Reserving Proprietary Names to FDA

The Food and Drug Administration (FDA) recently invited public comment on plans to allow pharmaceutical companies to reserve proprietary names as early as the end of Phase II trials. According to Regulatory Focus, FDA has posted the Pharmaceutical Research and Manufacturers of America’s (PhRMA) proposal to its public docket, offering the public a glimpse at what could become the basis for the future drug name reservation system. The document can be found here. We previously wrote about FDA guidance and proprietary drug naming here. Background Regulatory Focus previously provided a succinct explanation of this drug naming issue. As described in the article, the “proprietary” or “brand” name of a medication, makes it easily identifiable. However, because brand names are generally shorter than the established non-proprietary name for a drug, the potential for confusion can exist. A May 2013 article in the New England Journal of Medicine noted that many drugs approved in the last few years have started with the letters ”X” and “Z,” potentially confusing patients. FDA regulators try to reduce the potential for confusion by approving final trade names submitted by companies, assessing them for similarity to other names. Additionally, under a May 2014 FDA draft guidance, companies are supposed to subject any proposed name to real-world simulation studies, scenario-based testing, and an analysis of the name using a Phonetic and Orthographic Compute...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs