The U.S. Pharmacopeial Convention may well be the body to pull together a badly needed national drug pedigree program. USP has a unique relationship with the FDA, whereby the former sets the standards enforceable by the agency, and dozens of FDA volunteers sit on USP committees.
Additionally, both FDA and the other USP committee members--from industry, academia and healthcare--"leave their [industry/academia/healthcare] hats at the door," in the focus of their work for the nonprofit, says Anthony DeStefano, VP for general chapters, in a phone interview.
"That has worked well for us for decades," he says. "USP is not a consensus body, like ASTM (the American Society for Testing and Materials), for example; deliberately not." That's not to say that consensus bodies are biased, he adds, "but we go a step beyond."
In addition, USP oversight would mean that pedigree standards will "reside in a place where people would look for them," according to DeStefano. They will also be subject to updates on a regular basis. "A group of experts is thinking about it; keeping it fresh in real time," DeStefano says.
Here's another benefit: All of USP's work is open. Anyone can participate, and everyone can be aware of what's happening at any time--even those that have already started pedigree initiatives or elements that pertain, like GS1, GHX, Rx-360 and even HP, for example.
That's why USP has tied its pedigree program development effort to a workshop that will be held in Rockville, MD, May 22-23. The organization is inviting all interested parties to participate in the event, regardless of whether they are a traditional part of USP circles.
Hope to see you there.
George Miller - (email)
Editor's Note: The story originally stated the workshop would be held in March.