07/10/2018 | Press release | Distributed by Public on 07/12/2018 08:23
The Pink Sheet has quoted Akin Gump health partner Howard Sklamberg and associate Sudhana Bajracharya from a recent client alert discussing the Food and Drug Administration (FDA)'s new quality metrics pilot programs. The article notes that in the alert, Sklamberg and Bajracharya urge companies to think carefully before volunteering for the programs that were announced last month.
Sklamberg and Bajracharya said there are benefits to interacting with FDA officials outside of the application and inspection context. Most notably, pharmaceutical companies can showcase their quality metrics programs, get informal feedback and generate goodwill. On the other hand, there are some risks, including the fact that FDA assessment remains highly subjective.
What this means, Sklamberg and Bajracharya said, is that there is always the possibility that FDA might take a surprisingly dim view of the quality culture of a firm that volunteers for the programs.