krieger and dr. koh within the fda. just as it relates to resolving and mitigating these challenges. i can speak to a couple different references. one come a discussion earlier in testimony around court nation of importation of product to alleviate critical troop shortages. there was a specific instance in which we worked with the fda to bring a new product called leucovorin that's used in combination with chemotherapy to enhance the effect is said that treatment does so as to mitigate side effects. we brought it in and had a significant resources to work collaboratively with that and were able to help mitigate that problem. the solution that we are looking at recognizing as the multi-stakeholder issue. i do need to comment as it exists today, there is tremendous cooperation within the truck shortage crippen manufacturing community. as referenced earlier, there is no formal process. it's an informal process and i can speak on behalf of teva and other manufacturers in the state that we too will collaborate with the fds t

then -- >> same company. >> dr. koh, you mentioned glass and metal in injectables, i think, you were discovering which sent sort of shivers up everybody's spinement i've also heard -- spine. i've also heard, though w the new technologies the scientists are able to see deeper into the drugs than we've ever seen before, and parts per billion or whatever. again, this is your field, not mine. but are we looking deeper and finding things we never knew was there before? and is that really a problem from a health standard? or is it a question but may play a role? >> well, again, those examples, congressman, are very graphic examples of quality issues that we're facing. um, i must say, again, the fda has worked with companies. so in the case of particulate matter, pieces of glass, pieces of metal first to identify the issue, but also there have been advances in developing filtering systems so we can filter those out, make those drugs then safe to inject into patients. so that's another example of regulatory flexibility that has

krieger and dr. koh within the fda.ust as it relates to resolving and mitigating these challenges. i can speak to a couple different references. one come a discussion earlier in testimony around court nation of importation of product to alleviate critical troop shortages. there was a specific instance in which we worked with the fda to bring a new product called leucovorin that's used in combination with chemotherapy to enhance the effect is said that treatment does so as to mitigate side effects. we brought it in and had a significant resources to work collaboratively with that and were able to help mitigate that problem. the solution that we are looking at recognizing as the multi-stakeholder issue. i do need to comment as it exists today, there is tremendous cooperation within the truck shortage crippen manufacturing community. as referenced earlier, there is no formal process. it's an informal process and i can speak on behalf of teva and other manufacturers in the state that we too will collaborate with the fds tes

dr. kohhy have drug shortages and increased so much in the last few years? >> well, again there is no one single reason, but there are changes here that we are seeing in the backdrop of an economic and business climate that is leading to market consolidation, a complicated manufacturing process that is being conducted increasingly and aging facilities. it is leading to qualitative manufacturing issues as we have heard now. sometimes products are discontinued or business reasons. oftentimes the production of any of these agents is a complicated process of all these factors converged to create the issue we are facing right now. >> have other countries experience shortages such as we have? >> unfortunately the united states is not unique in this situation and yes, we are indeed seeing similar situations in other countries around the world. >> and where the shortage occurs in another developing country, how is that situation resolved their? >> we want to learn more from our colleagues there. i do