for testimony, ms. autor, it sounds like the one significant gap is the fda's limited ability to inspect foreign producers. can what can be done to inspect these facilities more frequently given wur limited resources? now one of the things you mention in your written testimony, that i think you are asking congress for, is the authority for the refusal of product admission into the united states if inspection of the manufacturing facility is delayed, limited or denied. is that one of the critical aspects of this? let's be honest about this. i believe fda needs more personnel. i fda needs more money. but in the climate around here i doubt that will happen. on the one hand we want more safety. we want to level the playing field. so you have offices right now, fda has offices in china and india and places like that. i don't know how well they are staffed. i know the offices are there. but speak to this, about inspections being delayed, about inspections, what good is it it if you have to announce it two, three we

ship to this country, they should, number one, allow inspections and as you pointed out, i think ms. autor pointed out, a lot of these times these are delayed. they are put off, put off, put off for year after year. the other thing is that i'm very much leaning towards this idea of more of a risk assessment. in other words, you know there are companies that have good manufacturing practices. they've been in business for some time, yet we, by law, say they have to be inspected every two years. maybe they don't need to be but maybe we need to use that personnel to go after the plants that haven't been to get actors or new plants that haven't been inspected at all. so these are all of the things that this committee is going to be looking at. we appreciate all of your testimonies and we'd appreciate any further input, advice, consultation that you have with us as we proceed on this. i'm committed to doing this. sometime -- well, sometime next year because we have to reauthorize pedufa and we didn't get into medical device but pedufa and the medical device user fee act. and keep in mind, is the

for testimony, ms. autor, it sounds like the one significant gap is the fda's limited ability to inspect foreign producers. can what can be done to inspect these facilities more frequently given wur limited resources? now one of the things you mention in your written testimony, that i think you are asking congress for, is the authority for the refusal of product admission into the united states if inspection of the manufacturing facility is delayed, limited or denied. is that one of the critical aspects of this? let's be honest about this. i believe fda needs more personnel. i fda needs more money. but in the climate around here i doubt that will happen. on the one hand we want more safety. we want to level the playing field. so you have offices right now, fda has offices in china and india and places like that. i don't know how well they are staffed. i know the offices are there. but speak to this, about inspections being delayed, about inspections, what good is it it if you have to announce it two, three we