>> absolutely and tore enzi. i understand you have questions for the record, pending the goa recommendations. they came in in august and we are working hard to respond to them. wasn't it make sure we get the technical fact right before we send them to you. we believe when we respond you will see we have continued to make serious challenge with congress and what gao pointed out. >> fda promulgates current good manufacturing practices or gmps to tell them how to manufacture drugs. given the risk of globalization, why hasn't the fda updated your know your suppliers nnps? >> there are some updates undercurrent law. we will try to do so if congress does not update the law. but updating the requirements through regulation is a lengthy uncertain expensive process for the taxpayers. potentially litigious with an unclear outcome. so the gao i think said that it is urgent for these issues to be resolved. i this i if congress believes the issues are also urgent then congress can help to resolve them quickly through legislat

>> absolutely and tore enzi. i understand you have questions for the record, pending the goa recommendations. they came in in august and we are working hard to respond to them. wasn't it make sure we get the technical fact right before we send them to you. we believe when we respond you will see we have continued to make serious challenge with congress and what gao pointed out. >> fda promulgates current good manufacturing practices or gmps to tell them how to manufacture drugs. given the risk of globalization, why hasn't the fda updated your know your suppliers nnps? >> there are some updates undercurrent law. we will try to do so if congress does not update the law. but updating the requirements through regulation is a lengthy uncertain expensive process for the taxpayers. potentially litigious with an unclear outcome. so the gao i think said that it is urgent for these issues to be resolved. i this i if congress believes the issues are also urgent then congress can help to resolve them quickly through legislat

enzi: mr. president, i ask unanimous consent that the senate proceed to a period of morning business with senators permitted to speak for up to ten minutes each, with an exception for myself and the other senator from wyoming, doing a tribute to malcolm wallop who passed away yesterday, that we might have such time as is needed. the presiding officer: without objection. mr. enzi: thank you, mr. president. i ask unanimous consent that the senate proceed to consideration of s. res 268 which was submitted earlier today. the presiding officer: the clerk will report. the clerk: s. res 268 relative to the death of the honorable malcolm wallop, former senator for the state of wyoming. the presiding officer: without objection, the senate will proceed to the measure. mr. enzi: i ask unanimous consent that the resolution be agreed to, the preamble be agreed to and the motion to reconsider be laid on the table. the presiding officer: without objection. mr. enzi: thank you, mr. president. it was with a mix

senator enzi. >> thank you, mr. chairman. mr. van trieste, your testimony suggestion that poorly declined reforms could exacerbate drug shortage problems. could you elaborate? >> as we talked earlier about if we increase regulation, certain players who are in the business today may decide to get out of the business. and they might make key -- might be the only supplier of a key ingredient for a critical medicine to treat patients. any legislation that we do i think we have to give the secretary some latitude to prevent those suppliers from existing the market and give them enforcement discretion on where to apply the regulations. we don't want to see people exit the market which are sole suppliers. >> dr. crosse what's what's wrong with the supply system and what does the f.d.a. need to do to fix them? >> there are several problems. they had a long history of poor information technology systems and they are in the process now of trying to upgrade those systems across the board, across the entire agency. that's taking several year

alexander: thank you, senator enzi. thank you for the leadership and the constructive way you and senator harkin are working together. i should emphasize i said in my remarks the respect we have for secretary duncan. he has done a great job of staying in touch with us without regard to political party and the president and he have stuck their necks out on some issues that aren't entirely popular with their democratic constituency. we respect that as well. as i said, our effort is to take these ideas and recognize we're in the ninth year of a bill that was supposed to be fixed after five years and get it done before the end of the year. one example of what we could do, the senator from illinois would talk about, he has been the leader on expanding opportunities for parents and communities to use charter schools. the house of representatives acted on that bill yesterday, senator kirk. mr. kirk: as part of this effort, i think we need to reform no child left behind. we need to focus on making sure we preserve disclosure. a

>> thank you, senator enzi. yeah, currently there's two components to i think to answering that question. the first being the parity that foreign establishments should be inspected at the same level intensity and frequency as domestic facilities. there's a substantial cost for inspections to drug companies. and i might use the example of companies setting in philadelphia or new jersey, may have fda visiting each month or the other month. and it takes resources, time, personnel to accommodate these inspections. the contrast is foreign inspections when companies, facilities are visited on a three, four, five-year basis. there's additional costs to the american industry and, more importantly, to the public health by having equivalence in terms of inspections, the fda has the opportunity to evaluate these foreign facilities, determine if there are any gmp or quality problems, supply chain issues and have those addressed in a timely basis. so bringing comperterability and inspection requirements, we believe, is very

that's why i've cosponsored legislation introduced by senator mike enzi closing this loophole. senator enzi's bill, s. 1376, changes the health care law's subsidy-eligibility calculation to include all nontaxable social security income. the congressional budget office and the joint committee on taxation estimate that if we enacted senator enzi's bill, we will save the federal government and the american people about $13 billion. the senate should immediately take up s. 1376 and pass it. this is $13 billion we can save right now today. let's show the american people that when we see our country spending money that it shouldn't, that we will take a stand collectively as a senate and stop it. now, these examples -- these two examples inevitably beg the question, what next? clearly, the self-described -- quote -- "most transparent administration in history" -- close quote -- has a lot of explaining to do i just don't believe that my friends on the other side of the aisle, who wrote this very flawed health care law -- and they did it behind closed doors -- he just don't think that t

enzi have already called to improve the oversight of the pharmaceutical supply chain. i would hope the committee would follow suit but i would like to have you give a statement of what authority need to adequately carry that out. i don't believe in sending you a letter asking you to do something for which you have no authority. would you submit for the record because my time is up what it is that has to be done to give the authority to address those problems? >> i would be happy to. >> i think you for your courtesy and i ask unanimous consent that the responses be inserted in the record. >> without objection, so ordered. we recognize the gentleman from louisiana, dr. cassidy for five minutes for questions. >> callow. thank you. >> you do have the ability from overseas obviously come and so those issues raised regarding the adequacy of quality control of you help with the def heparin from china causing many deaths, correct? one of the issues raised here in the previous hearing is that the inspectors as part of the union contract are not come can refuse to go overseas an

you heard about the commercials from senator enzi. a group of young people had gathered around to support his very unlikely bid to serve wyoming in the united states senate. the national press called it the children's crusade. many of those young people came to washington with him, and my wife bobbi brown was among those who began her own public service career as part of his first-term staff. it is an indication of the affection and the loyalty felt by those who were part of his team that more than 60 people gathered together with malcolm in wyoming in 2006 for a 30-year reunion. he served three terms this the senate and his work here was very broad in scope. his presence was lasting, and it touched on the mercurial issues of the late 70's and 80's from energy policy to the environment, from national security to tax reform. one of our own colleagues, senator carl levin said of malcolm, quote, "while we disagreed again probably as often as we agreed, that didn't stand in the way of my admiration for the quality, the characteristic that

i've worked closely with senator enzi, who has been a cochampion in this regard, on this legislation to address all concerns. since it cleared the help, education and labor committee with full bipartisan and unanimous support, i thought we succeeded in addressing those concerns. i have not been approached or heard a single objection from any republican as to why they might hold this bill, and i have been open in my willingness to work with the other side in addressing their concerns with the bill's policy. having not heard a single objection to the merits of this legislation, which, by the way, the exact replica is being offered by the republican majority in the house, i have to assume that this is for reasons other than policy. we've had a week to have the opportunity to bring this forward. it has caused incredible uncertainty and unnecessary worry for the parents of children with autism as they wait anxiously to learn if the government is going to continue to reauthorize the very essence of the program that has helped their children be able to fulfill their god-given potential to t

enzi have already called to improve the oversight of the pharmaceutical supply chain. would hope the committee would follow suit but i would like to have you give a statement of what authority need to adequately carry that out. i don't believe in sending you a letter asking you to do something for which you have no authority. would you submit for the record because my time is up what it is that has to be done to give the authority to address those problems? >> i would be happy to. >> i think you for your courtesy and i ask unanimous consent that the responses be inserted in the record. >> without objection, so ordered. we recognize the gentleman from louisiana, dr. cassidy for five minutes for questions. >> callow. thank you. >> you do have the ability from overseas obviously come and so those issues raised regarding the adequacy of quality control of you help with the def heparin from china causing many deaths, correct? one of the issues raised here in the previous hearing is that the inspectors as part of the union contract are not come can refuse to go overseas and

while there is no single solution that will immediately solve the problem of drug shortages, derek enzi can do to help address this issue. first, bipartisan legislation in both houses of congress would enable fda to require the drug manufacturers report confidentially to the agency when they variants and interaction in the production of their product. there's early warning system of the fda work with other manufacturers to ramp up production when another company experiences a problem. moreover, the bills call upon fg to work with manufacturers to develop continuity of supply plan, which could help to identify backup sources, pharmaceutical ingredients and produce redundancies and inventory to serve as reserve supplies. summit argued that this legislation won't have any impact, we won't disagree. your party heard this morning from the fda that in 2010, 38 drug shortages were avoided in the last year 99 drug shortages were avoided when the agency was giving it to notice. further opponents of this approach argue that it will lead to hoarding. we know that hoarding already occurs. how do so

enzi: thank you, mr. president. yesterday marked ten years since the horrendous attack of americans on american soil, but it led to a lot of patriotism and a lot of flags being displayed all over the country. over the weekend, i noticed that my 3-year-old granddaughter and my 4-year-old granddaughter, when they saw a flag hanging anywhere, said "god bless america." throughout the history of the united states, each generation has had at least one iconic moment, one moment in time that served to galvanize the nation and call each and every american to take on a cause much greater than themselves. ultimately, the results they were able to achieve served to define who they were as a generation and what they were capable of, both as individuals and as a nation. for my father, that moment was the bombing of pearl romero-barcelo. as we watched with growing concern, a terrible evil had taken the whole world to the brink of war. now we found we no longer had a choice as to whether or not we would get involved. we were forced

enzi have already called to improve the oversight of the pharmaceutical supply chain. i would hope the committee would follow suit but i would like to have you give a statement of what authority need to adequately carry that out. i don't believe in sending you a letter asking you to do something for which you have no authority. would you submit for the record because my time is up what it is that has to be done to give the authority to address those problems? >> i would be happy to. >> i think you for your courtesy and i ask unanimous consent that the responses be inserted in the record. >> without objection, so ordered. we recognize the gentleman from louisiana, dr. cassidy for five minutes for questions. >> callow. thank you. >> there's enough money to inspect every two years there. it's happening only every other nine. ask can we direct resources to send that person over to maybe alleviate some of these by expanding importation, the point was that the unions would not allow this to occur, that they had the right to refuse the overseas assignment. is that true? and t

enzi, have already called on food and drug to improve its oversight of the pharmaceutical supply chain would hope this committee would follow suit, but i would like to have you give us a statement of what authorities you need to adequately carry that out. i don't believe that sending you a letter asking you to do something for which you have no authority works. would you submit, please, for the record -- because my time is up -- what it is has to be done to give you the authority to address those problems. >> i'd be happy to, congressman. thank you. >> thank you. mr. chairman, i thank you for your courtesy, ask unanimous consent that the responses be inserted in the record. >> thank the gentleman, recognize representative cassidy for five minutes. >> there's issues raised regarding adequacy of quality control if you will. we think of heparin from china causing many deaths, right? one of the issues that was raised here in a reeves hearing was that the -- in a previous hearing was that the inspectors as part of their union contract are not -- can refuse to go overseas. and so i think mr.

enzi: mr.president, i would ask that the quorum call be suspended. the presiding officer: without objection. mr. enzi: mr. president, it's with a great deal of sadness that i have to tell you that senator malcolm wallop, the 18th senator for the state of wyoming, passed away this afternoon. he's been ill for sometime, but has had a very active life and made a great deal of difference in this body. we were very fortunate to have malcolm wallop represent us in the senate for 18 years, and for all of his three terms he was a powerful and effective presence in the congress that ensured people of wyoming that they were heard and that their concerns were being addressed. although there are many accomplishments that i could mention -- and tomorrow i will probably mention quite a few more -- i want to mention two of them today. because they were very significant efforts. the first was the establishment of the republican steering committee. he and two other senators considered themselves to be the conse