The PharmaTech Talk blog recently had an interesting post on the FDA's plans to have greater collaboration with USP. FDA Commissioner, Margaret Hamburg, made these comments at the most recent USP Convention.
"First, Reference Standard Candidate Assessments will test standard candidate materials that are controlled substances.
Second, to combat economic adulteration, FDA and USP will exchange information on hand-held device applications designed to screen drugs for adulteration or contamination and will explore ways to integrate the requirements of those new technologies into USP’s documentary standards.
And third, FDA will assist in the development and modernization of USP monographs providing enhanced tests and assays to better assess and characterize drug ingredients and products."
This looks like a good approach to me. I like the agency's new priority toward collaboration with outside experts. This willingness to collaborate actively with USP seems similar to the FDA's earlier announcement this year that it would seek more active discussions with experts within the NIH to help speed drug application reviews. This seems like a common sense approach to combine expertise from two sources to get a more wholistic picture and better result.
With the drug adulteration issues that have arisen in China, and elsewhere, in past couple of years, it makes sense to tap and share expertise to use resources better and to institute best practices wherever possible. I like the USP collaboration's emphasis in looking at hand held technology to better detect contamination or adulteration. Certainly, there is always room to look at imporving the science and analytical techniques spelled out in the monographs - there is more rapid evolution in testing and a greater need to stay current to meet the global regulatory challenges. Especially, with the vast increase in volumes, shipments and nations involved in the supply chain.
This move is consistent with what our customers have spoken to us about in regard to improving testing around raw materials used in biopharmaceutical processing. Effectively the 3 FDA areas of emphasis with USP, will help to improve raw material characterization, and will do so in way that is relevant to the end users intended applications. This will also be in alignment with the regulatory process. This can only help move us toward a more secure global supply chain with more harmonized criteria for assessing quality. This should lead to safer and better raw materials with consequent better final drugs coming out of these processes.
I applaud this idea. I'd like to see it move rapidly toward collaboration and implementation. There may also be an opportunity here to tap into private company expertise and subject matter experts. This could build upon the planned FDA-USP collaboration and go even further to incorporate testing standards, technologies and methods that are especially relevant to the industries and supply chains being regulated.
Posted by Bruce Lehr April 30th 2010.