franken. senator collins. senator collins: thank you, mr. chairman. dr. woodcock, first let me thank you for your many years of public service and all that you're doing to expedite generic drug applications in order to make prescription drugs more affordable for consumers. i know that you're familiar with the investigation, the aging committee is doing into the sudden, very aggressive price spikes that some companies have implemented on drugs that have been on the market for literally decades. one is 63 years old. 5,000% there's been a increase in its price bye buy a company that invested not one dime -- price by a company that invested not one dime in the

mr. chairman: thank you senator franken. senator whitehouse. sen. whitehouse: following up on senator warren's questions, it strikes me that one of victories we have achieved has been to bring mental health out of the shadows and de-stigmatize it. not completely, not as much as it should be, but there have been some real victories. i want to commend my former delegation member, representative patrick kennedy of rhode island on the parity act, which has helped make that the law of the land as opposed to just a good social change. in addition to the problem of getting insurance coverage, is there not also the underlying problem that our infrastructure for mental health treatment was basically built during a heavily stigmatized period, when very few people came forward? it was designed to address a fraction of the real mental health problem. in rhode island, we have some of the best mental health facilities in the country. our best in show world-class facilities, and yet they are all they are. you get beyond that, and you have difficult situations. oft

franken. >> thank you, mr. chairman. thank you for your service and your work to expedite generic drug applications to make prescription drugs more affordable for consumers. i know that you're familiar with the investigation the aging comm committee is doing to the sudden aggressive price spikes that some companies have implemented on drugs that have been on the market for literally decades. one deraprim is 63 years old. and yet there's been a 5,000% increase in its price by a company that invested not one dime into the research and development that led to this drug. so, i'm concerned that our current regulatory structure doesn't take into account situations where there is essentially a market failure. because the population of patients may be small, there's no generic application, whether it's pending or not, it just hasn't happened. now, i know that the fda currently provides an express lane review for certain generic drug applications including first generics and those that would help solve medical drug shortages. cou

franken. >> thank you, mr. chairman. i'm sorry i wasn't here for your testimony. i had some other meetings. i wasn't able to read your testimony because our office didn't get it until late last night or early this morning. this is a subject that's interested me for decades. you're talking about overprescription of these. one of the causes, senator shay and mingsed this. medical school, this has been something i've heard about for decades and it doesn't seem to get corrected. we've had addiction problems in this country for a long time. this is not new. why don't we have in medical school mandatory instruction to our -- to doctors or to medical students information about what addiction is? because we don't seem to have it. and we should have have it at nursing school, too. but if you have doctors prescribing and these drug monitoring programs, prescription drug monitoring programs should be mandatory. any time you're prescribing an opioid, you should be having to look and see what this history is. we know now what a serious problem is. but anybody here have a stron

senator franken: thank you, mr. chairman. sorry i wasn't here. i was at other meetings and was not able to read your testimony. our office didn't get it until late last night or early this morning. this is a subject that's interested me for decades. you're just talking about prescribing overprescription of these. one of the causes -- and senator shaheen mentioned this and i thought it was incredibly important is medical school. medical school, nursing school. it's been something i have heard about for decades and doesn't seem to get corrected which is that we've had addiction problems in this country for a long time. this is not new. why don't we have in medical instruction to medical doctors or to students, information about what addiction is? because we don't seem to have it. and we should have it at nursing school too. but if you have doctors these drug nd monitoring programs, prescription drug monitoring programs should be mandatory. anytime you're prescribing an opioid, you should be having a look and see what this history is. because we kno

franken. senator collins. senator collins: thank you, mr. chairman. dr. woodcock, first let me thank you for your many years of public service and all that you're doing to expedite generic drug applications in order to make prescription drugs more affordable for consumers. i know that you're familiar with the investigation, the aging committee is doing into the sudden, very aggressive price spikes that some companies have implemented on drugs that have been on the market for literally decades. one is 63 years old. 5,000% there's been a increase in its price bye buy a company that invested not one dime -- price by a company that invested not one dime in the research and development that led to this drug. i'm concerned that our current regulatory structure doesn't take into account situations where there is essentially a market failure, because the population of patients may be small. there's no generic application. whether it's pending or not. it just hasn't happened. now, i know that the f.d.a. currently provides an express lane review for certain generic

mr. chairman. >> thank you, senator warren for the suggestion. senator franken. >> thank you, both the chairman, ranking member, for these series of hearings. dr. eaton come in your testimony you talk about the importance of preventing mental illness. so do, dr. hepburn. dr. eaton highlights programs such as the nurse family partnership program which has been ineffective in identifying high risks, assisting birthing moms after birth. i really do believe convention is important that's why author and help advance the mental health and schools act which will increase access to mental health services in school settings. mr. eaton, what percentage of individuals with mental illness experience onset before the age of 18? >> it depends on which mental disorders you talk to. i think before taking for depressive disorder is probably, a full-fledged disorder is probably 20% but the beginnings of it are available, 50% of the people who will become depressive disorder full-fledged in a lifetime complexity before the age of 35 already expressing symptoms at 15. and so they w

franken, who needed more time. >> it's going to take me about 25 seconds to recall where i was. i will yield my time. >> thank you for this outburst of bipartisanship. senator casey? >> mr. chairman, thank you very much. doctor, great to have you here. thank you for your testimony and your service. i wanted to focus on an area that i know you have spoken to but i'm not sure this specific question was asked about the so-called, we have to be careful with acronyms here, the risk evaluation mitigation strategy, then the other, the elements to assure safe use. the basic question i had was when you testified about some of the challenges that you have in implementing shared risk evaluation system, can you outline for us the challenges you face and then if any, and i'm assuming there are, what you propose as solutions? >> well, when congress in the fda amendments act put in place the rems, when they had to contemplate, and that's a risk evaluation and mitigation system that's supposed to particularly risky drugs, it's supposed to mitigate some of the risks. and we approve drugs with rems if they are particularly risky. when they go generic, the generics also need to have this

franken, who needed more time. >> it's going to take me about 25 seconds to recall where i was. i will yield my time. >> thank you for this outburst of bipartisanship. senator casey? >> mr. chairman, thank you very much. doctor, great to have you here. thank you for your testimony and your service. i wanted to focus on an area that i know you have spoken to but i'm not sure this specific question was asked about the so-called, we have to be careful with acronyms here, the risk evaluation mitigation strategy, then the other, the elements to assure safe use. the basic question i had was when you testified about some of the challenges that you have in implementing shared risk evaluation system, can you outline for us the challenges you face and then if any, and i'm assuming there are, what you propose as solutions? >> well, when congress in the fda amendments act put in place the rems, when they had to contemplate, and that's a risk evaluation and mitigation system that's supposed to particularly risky drugs, it's supposed to mitigate some of the risks. and we approve drugs with rems if they are particularly risky. when they go generic, the generics also need to have this

mr. franken: thank you, mr. president. i want to thank the senior senator from minnesota for her remarks about wilhelmina wright. i join her today in rising not just to -- not just in strong support but enthusiastic support for justice wilhelmina wright's nomination to serve on the united states district court for the district of minnesota. we call her justice wright because she is on the minnesota supreme court. she is an excellent consensus nominee. i'd like to thank chairman grassley and ranking member leahy for working to ensure the judiciary committee reported her nomination out favorably. i'd also like to thank leader mcconnell for scheduling today's -- this afternoon's vote. as of today, justice wright's nomination has been pending for 2779 days, more than nine months, and the seat that she is nominated to fill is considered a judicial -- has been declared a judicial emergency. so i'm pleased that the senate today is moving to confirm justice wright and that minnesotans seeking justice will soon be able to have thei