And looked, i believe, more closely and probingly at effectiveness and again concluded that the program came up short. But those two questions, what is the Legal Foundation and what is the effectiveness despite all of that structure i believe they never really got in 10 years of this program adequate attention. I want to take the prerogative of the chair to observe in response to senator whitehouses point that none of the oversight was adversarial in nature. Which is why i propose the constitutional advocates. Courts always do better when they hear both sides, the process is well served when there is contention as there was within this board. Might just point out that the dissent by ms. Brand says in commenting on whether the board should consider the legal question as you very thoughtfully observed and im quoting, this legal question will be resolved by the courts not by this board, which does not have the benefit of traditional adversarial legal briefing and is not particularly well suited to conducting de novo review of longstanding statutory interpretations. At least part of that observation can be said of the fisa court and of the legal review and perhaps factual review thats been conducted in this program. The oversight may have been numerically abundant, but as you observed, senator whitehouse, potentially lacking in quality. Im going to have to go to the vote. Senator whitehouse moves more quickly. Well go ahead and ill let the chairman conclude the hearing. I would just note in reply that the great adverse relationship that the Founding Fathers built into the constitution was the adverse relationship between the legislative and the executive branches, which they characterized as one of jealousy and rivalry that was to be harnessed for the good of the public. I would hate to think that just because there wasnt a lawyer in the courtroom with a general ublic interest purpose, that there was not adversarialness in all of this. There should have been and the structure of our government creates that adversarialness, and if that has not been adverse enough, then thats our fault, but its not the fault of the lack of additional lawyer in the courtroom at the fisa court. I dont think lawyers are necessary for adversarial contention, but i think your point is well taken. Im going to close the hearing. Leave the record open for one week. And again thank the panel for being here, for your very thoughtful and insightful and very helpful testimony. Again thank our entire Intelligence Community that day in and day out work to grapple with these very difficult and challenging questions. Thank you. The hearing is closed. [captioning performed by national captioning institute] [captions Copyright National cable satellite corp. 2014] note we will hear more from david medina was in this hearing. This will be airing at 10 00 a. M. And 6 00 p. M. Here on cspan. In the meantime, heres a preview. We operated in an area where there is a lot of classified information. We are able to push back and urged declassification that is important for the American People to understand a program. You might have pushed for declassification . We might. Program wethe entire absolutely will consider going to the Intelligence Committee and say we need to declassify the so we can have a fuller, National Debate here in Greater Transparency in the loss of theres no secret law with the American People cannot determine whether a program has been authorized. We are urging the government to report more on the information election activities and to authorize private companies to let their companies customers know more about the customer requests. Some of these have reached an theseent now about how apply. Have ecb countries attitudes and the balance between National Security and privacy changing . I think the first reaction was how to meet beef up our efforts to protect against future terrorist attacks. I think we have struck more of a balance between National Security and privacy and Civil Liberties. Theres an interesting poll done right after the boston bombing. A substantial percentage of people said they would not give up their Civil Liberties for greater security. This. Act tour we are not in advocacy organization. We are ignoring the consequences to National Security. We have to strike the balance and they have only protect the country and benefit . The president has said the same thing. If we give up one, we have lost a lot. A. M. E at 10 00 reuters reporting on some of the german chancellor Angela Merkel is doing to adjust concerns about the nsa spying abroad she looks to create a Communication Network within europe that would prevent emails and other data from passing through Search Engines like google or facebook. Proposal is in response to reports at the nsa has collected data and phone calls on people in germany and other foreign countries, including the wiretapping of her own cell phone. She plans to discuss her idea with francois hollande. President will on president whole president hollande will be shown later this evening at the white house state dinner. Ask cspan, we bring Public Affair advance from washington directly to you, putting you in the room at congressional hearings, white house events, briefings and conferences, and offering complete gavel to gavel coverage of the house as a public service. By the cabled Television Industry 35 years ago and funded by your local cable or satellite provider. Watch as an hd and follow us on twitter. Inergy and commerce subcommittee on Health Talking about the judge drug shortage problem. When is our officials from the fda and the Government Accountability office. It was hell for little more than an hour. The chair will recognize himself or an Opening Statement. In recent years we have seen a genetic increase of the number of drug shortages in the united states. Particularly with generics. While the number of new shortages dipped into 2012 and 2013, the total number of ongoing shortages has continued to increase. This is unacceptable. Numerous drugs have remained on f. D. A. Shortage list for some time. What is the agency doing to help address these situations . Recent news reports have highlighted shortages of oncology products, nutrition products, and even common yet critically important saline solutions. Such shortages lead to delays in treatment, rationing of care, and higher cost. They can also pose greater risk to patients in the norm of medication errors, and as providers are forced to seek alternative treatments. Drug shortages are a very challenging problem, and it is clear that there is no simple solution. We recognize the complicated nature of this issue, as well as the severity. Last congress the subcommittee took action by including a section on drug shortages in the food and Drug Administrations safety and innovation act, which was signed into law on july 9, 2012. Title 10 of fdasia sought to give new authorities and responsibilities to the food and Drug Administration and having drug manufacturers notify f. D. A. Of a discontinuance of production. Among other provisions under fdasia the secretary of health and Human Services is required to, one, maintain a publicly available uptodate drug shortage list. Two, establish a task force to implement a Strategic Plan to mitigate drug shortages. Three, submit annual reports to congress including relating actions taken by the agency. Fdasias also required g. A. O. To examine the cause of drug shortages and formulate recommendations on how to prevent or alleviate drugs on such shortages. Last october, f. D. A. Issued its Strategic Plan for preventing and mitigating drug shortages. Further, we now have f. D. A. s first annual report on drug shortages, though it only covers the first three quarters of 2013. And today g. A. O. Released its final report pursuant to fdasia. While drug shortages continue to plague our health care system, statistics do indicate progress on some fronts. I would like to welcome our witnesses, marcia crosse, Health Care Director at g. A. O. , and douglas throckmorton, director of programs at f. D. A. I would like to thank g. A. O. For their comprehensive report and the time they have spent with my staff on this issue. I yield the remainder of my time to vice chair dr. Burgess. Thank you, mr. Chairman. When doctors dont have the essential tools, they are restricted in what they can do for their patients. Members of this committee have taken the lead and made major strides in working to reduce drug shortages by passing the food and Drug Administration safety and innovation act of 2012. In addition, i have worked very closely with chairman upton and chairman pitts on several of the provisions contained therein, and things have gotten better, but the problems are not completely gone. As recently as last week, food and Drug Administration listed sodium chloride injection bags as a drug shortage. Sodium chloride is not a particularly esoteric or exotic molecule, for having that much trouble with salt it only makes you wonder what other more difficult molecules we may encounter there. The food and Drug Administration has a role in addressing drug shortages, but it is a complex issue. In 2010 over 240 drugs were in short supply, and over 400 generics were back ordered. Many generics have a line so tight when the production is corrupted the company cannot afford to continue its manufacturer. This inevitably leads to more than 3,000 backlogs of generic applications. Physicians are still faced with having to tell patients they cant receive the care they need not because there is no treatment but because a product is simply not available. I thank the chairman for holding this hearing so we can learn more about the progress that is being made on the nations drug shortage problem. I am pleased the General Accounting Office report is being released. I look forward to hearing from them on their findings. The law is aimed to ensure that providers have the tools they need to alleviate suffering. The suffering of every patient and certainly im anxious to hear the testimony today. Yield back to the chairman. The chair thanks the gentleman. Now yields five minutes for Opening Statement to mr. Pallone. Thank you, chairman pitts. Im glad we are having the hearing today on this critical issue of drug shortages. Over the past several years we saw an alarming trend of increases in drug short ands, and we knee the devastating effects this can have on patients, potentially prolonging disease or causing permanent disability or even death. This is an issue i and many of my colleagues on the committee have long been concerned about. Congress took action to provide the food and Drug Administration with tools to help address this problem through provisions in the food and Drug Administration safety and innovation act, or fdasia, which passed on a strong bipartisan basis in the summer of 2012. In fdasia we asked the Government Accountability office to review several factors related to drug shortages. Update work done previously, and they released that report today and im glad dr. Crosse is here to discuss it further. I want to take a moment to highlight some of the other aspects that address the drug shortage problem. In its 2011 report on drug shortages, the g. A. O. Recommended, and we heard from heard this from stakeholders, too, an early notification requirement for potential shortages so that f. D. A. Can work with manufacturers sooner to take steps to prevent or mitigate shortages. We included such a requirement in fdasia and its encouraging that the number of new drug shortages declined in 2012 compared to the previous two years, and that partial data from 2013 indicates that the trend is continuing. The f. D. A. Has cited this and other fdasia drug shortage provisions as contributing to their ability to prevent by their calculation 140 drug shortages in the first three quarters of 2013. We also heard from stakeholders the need for review times for generic drug applications and reduce the significant backlog of pending applications and the generic user Fee Agreement that was passed as part of fdasia was important in getting f. D. A. The resources it needs to make that happen. We have learned that it can be important to have multiple manufacturers, especially for the most medically important drug, to help alleviate drug shortages. As we heard from f. D. A. A few months ago, the agency has been aggressively hiring f. T. E. s first generic drug program, meeting hiring goals as part of its efforts to tackle the backlog and speed up review times. These are some of the steps that have tan taken to address drug shortages which is a complex problem. As im sure well hear today from our witnesses, drug shortages remain high and remain a problem. Many of the shortages are still sterile injectable drug, and i am aware they face unique challenges because they are technically difficult to manufacturer. Each drug is often manufactured by one or small number of Companies Making it difficult for other companies to be able to fill the need if any one Company Develops manufacturing problems. Its clear while we have made progress in some areas, our work is not over. I thank our witnesses from f. D. A. And g. A. O. For being here today to continue our discussion on the topic of drug shortages. I look forward to learning more about what we can do to further prevent them. Thank you very much. Thank you, mr. Chairman. I yield back. Thank you, mr. Chairman. I want to welcome our witnesses, i thank youall for being here. I thank the chairman and vice chairman of the committee for their attention to this issue. As youall know, 2011, 2012 we held hearings, we have worked to through this process and what the factors are that are causing the drug shortages, and we know that they have increased in recent years, and im one of those, i believe, lets get to the root cause. And to the root problems so that we are solving this. I continue to talk with those Health Professionals in the community and tennessee and get their input on this. We did take a bipartisan action, as the chairman and Ranking Member have mentioned, and that was to address through fdasia the shortages and fdasia did provide f. D. A. With authority they needed. It put new requirements on the manufacturers to help prevent and mitigate the shortages shall or supposedly on paper thats what they are to do. This is a wonderful opportunity for us to look at the g. A. O. Report, to question you, to hear from you, and to continue to try to look at this systemically, holistically, and get to the root causes of solving this problem. Mr. Chairman, i yield back to you for further yielding. The chair thanks the gentlelady. That concludes the members Opening Statements. On the panel today we have two witnesses, dr. Marcia crosse, director health care u. S. Government accountability office. And dr. Doug throckmorton, Deputy Director for regulatory programs. Center for drug evaluation research, u. S. Food and Drug Administration. Thank you for coming. Your written testimony will be made part of the record. Youll have five minutes to summarize your Opening Statement. And at this time the chair recognize dr. Crosse for five minutes for her summary. Chairman pitts, Ranking Member pallone, and members of the subcommittee, im pleased to be here today to discuss our work on drug shortages. As you know prescription drugs are a critical part of medical care, but over the last decade theres been an increase in the number of drugs that are in shortage. This has included drugs to stabilize trauma victims, to control pain during surgery, to treat Heart Disease and cancer, and to provide nutritional support to premature infants. Today g. A. O. Released our report on drug shortages, a study you mandated in the f. D. A. s safety and innovation act and im happy to discuss our key findings. We found that the number of drug shortages remains high, and that providers experienced challenges responding to shortages without adversely affecting patient care. Beginning in 2007, the number of new drug shortages increased each year until 2012, when the number of new shortages declined, and that downward trend appears to have continued through 2013 based on the partial year data we analyzed. While the number of new shortages has declined, the total number of shortages, including both new shortages and ongoing shortages that began in a prior year, has continued to increase because many shortages are prolonged with some spanning multiple years. The majority are injectable drugs, particularly generics. Shortages of medically necessary drugs can have a range of negative effects. A drug shortage may require providers to delay or ration care, create difficulties finding alternative drugs, increase the risk of medication errors, lead to higher costs, reduce time for patient care, and result in the hoarding or stockpiling of drugs and shortage. For example, providers may have to ration care by prioritizing the patients who have a greater need for the drug. The immediate cause of a drug shortage can generally be traced to a manufacturer halting or slowing production to address quality problems, triggering a supply disruption. Other manufacturers have a limited ability to respond to supply disruptions due to constrained manufacturing capacity. We also identify potential underlying causes specific to the economics of the generic sterile injectable drug market. Such as that low Profit Margins have limited Infrastructure Investments or led some manufacturers to exit the market. Although there are few studies of underlying causes, among the issues that have been examined are that purchasers focus primarily on price rather than quality, reducing incentives for manufacturers to invest in maintenance or quality improvements. That Group Purchasing organizations negotiate reduced drug prices on behalf of hospitals and other providers, lowering Profit Margins for manufacturers that win contracts, and leaving losing manufacturers to exit the market. And a 2005 change in Medicare Part d drug reimbursement policy for outpatient providers decreased both demand and prices for generic drugs. The stakeholders we met with, which included manufacturers and Group Purchasing organizations, had mixed views on these potential underlying causes with no general agreement on the role such factors may play. In examining f. D. A. Activities, we found the agency has prevent more potential shortages and improved its ability to respond to shortages in the last two years. The new requirement that manufacturers must notify f. D. A. In advance of a potential shortage has allowed f. D. A. To take steps to prevent and mitigate shortages sooner. For example, it has expedited application reviews and inspections, exercised Enforcement Discretion, and helped manufacturers respond to quality problems. These steps are important to respond to some of the immediate causes of shortages. However, some of the underlying causes we identified are beyond the agencys authority, as f. D. A. Does not have control over private Companies Business decisions. For example the agency is unable to require manufacturers to start producing or continue producing drugs, or to build redundant manufacturing capacity, regardless of the severity of a shortage. Nonetheless, f. D. A. Can take steps to maximize the agencys use of the information it has to address drug shortages. We identified shortcomings in its management and use of the agencys drug shortage data. In our report we made recommendations to f. D. A. To improve its database and coven duct routine analyses and the agency has agreed with these recommendations. In summary, while f. D. A. Has made progress in preventing potential drug shortages and responding to actual shortages, the number of shortages remains high and many persist for months and even years. The large number of potential shortages reported to the agency suggest the market is still atrisk of supply disruptions. As a result, patients and providers will continue to struggle as essential and lifesaving medications remain in short supply. Mr. Chairman, this completes my prepared statement and i would be happy to respond to any questions you or other members of the subcommittee may have. Thank you. The chair now recognizes dr. Throckmorton for five minutes to summarize his Opening Statement. Mr. Chairman and members of the subcommittee, im douglas throckmorten, Deputy Director for evaluation and research. Thank you for the opportunity to speak to you today about what the f. D. A. Is doing to address drug shortages. Drug shortages as others have said are usually preceded by a disruption in manufacturing of a product. Some product disruptions are manufacturer controls such as decisions to permanently discontinue production of a drug thats no longer profitable. Other factors are outside the manufacturers control such as natural disasters or the unavailability of materials needed for manufacturing. A particular problem when materials are only available from one supplier. Most often, however, shortages are the result of quality failures within manufacturing facilities. Such as failing to follow proper procedures that allow bacteria to grow in a product. Quality failures can result from maintaining a manufacturing line. For example, poorly maintained old equipment has led to the introduction of iron particulates in injectable products. Prevent this requires the manufacturing to commit to Quality Manufacturing. Turning to drug shortages in the u. S. Today, while work remains, progress has been made in the prevention and resolution of drug shortages in the united states. The agency is well positioned to work with manufacturers to find ways to prevent or reduce a shortages impact on patients, provided we are aware there is the potential for a shortage. Timely notification by manufacturers has helped. And has enabled f. D. A. And manufacturers to prevent 170 shortages in 2013. We are also seeing fewer new shortages. The number of shortages rose the number of new drug shortages have fallen to a low of 44 in thrown. There do, however, continue to be shortages that persist for longer periods. Here, while progress is being made, is tracking and working to resolve a number of shortages earlier. This is established by working with f. D. A. And working with manufacturers who are willing and able to increase shortages, expediting f. D. A. Inspections, both from manufacturers who are currently producing as well as those who are and products not meeting established standards to allow them to remain available safely. While f. D. A. Standards for safety, efficacy do not change in shortage situations, they balance the need of patients, especially with patients with limited treatment options. F. D. A. Makes sure that drugs are considered before issuing warning letters. In appropriate cases, regulatory flexibility is an important actual in ensuring access to needed drugs. As a part of f. D. A. s work on drug shortages in 2013, the f. D. A. Released its Strategic Plan as called for. The goals of the plan is to improve the agencys response to drug shortages and have longer term to addressing shortages. First, to address existing shortages, f. D. A. Is focusing in three areas. First, were improving communications within the f. D. A. To ensure that our decisions are efficient and appropriate. Second, we are improving our databases related to drug shortages, dedicating a system to improve drug shortages and allow us to have prevention and drug shortages, including the work we do to produce the annual report to congress. Third, f. D. A. Continues to work to improve timely and accurate drug shortages to patients and caregivers. Recognizing it begins with the spry disruption related to product quality. It encourages and sustaining improvements in manufacturing quality. For over a decade, f. D. A. Has been working with academics and experts to have technologies linked to manufacturing quality. In conclusion, progress has been made in efforts to prevent and mitigate important drug shortages aided by Early Communications about shortages. Shortages do continue to occur. F. D. A. Will continue to work to address them. Importantly, f. D. A. Will continue to work with others to support the pharmaceutical industry in their longterm efforts to modernize drug manufacturing to prevent shortages. By working together, we can prevent drug shortages from occurring, address them when they do occur and im happy to answer any questions that you have. The chair thanks the gentleman. That concludes the Opening Statements of the panel. Well now begin questioning and ill recognize myself for that purpose for five minutes. Dr. Throck morton, while the report be submitted no later than december 31, 2013, f. D. A. s first annual shortages report was submitted to the committee on february 5. And with data from only the first three quarters of 2013. You notice in your testimony that 170 new shortages were prevented in 2013. This is up from 140 in the report f. D. A. Submitted to the congress. I assume that means that f. D. A. Claims to have prevented 30 shortages in the fort quarter of the year, is that correct . We do have our full year Data Available now and well be happy to share that with you, mr. Chairman. Lets use that smaller sample size for sake of discussion. It will be helpful to have more detailed examples of how f. D. A. Prevented these shortages. What specific actions did the agency take . Which drug products would currently be in shortage if not i can get you some specific information but i can give you some general examples if that would be helpful. One issue is something called regulatory flexibility. These are places where we either expedited additional actions that would otherwise have taken a bit longer or done additional work on it. Last year we had 76 instances of regulatory flexibility that we exercised, effecting a total of 68 products. Theres a another way to try to speed the development of products or assure that products that would potentially go into shortage remain available. So several of the offices receive applications from sponsors for new factories, for new lines within a factory. Last year my office of generic drugs expedited 118 applications involving a total of 62 accelerated new drug applications. So an important number of products where we worked hard to make certain they were more quickly reviewed than normal. Our office of new drug quality, which is another office looking at supplemental applications to approve drugs, approve innovator drugs. Looked at 52 supplemental applications. My office of biologic products, in terms of therapeutics, they expedited seven review applications last year. So in total those things reflect the kind of commitment my center has towards looking at these things, devoting our resources to do it. Ok. You mentioned the office of generic expedited 118 applications, including 62 abbreviated applications. In order to prevent a shortage, how many of those applications were actually approved . You know, i need to get back to you with that information. Obviously were applying those new standards. Our usual standards. But 118 speaks to the effort we undertook. On average, how long did f. D. A. Take . Thats a good question. Ill get back to you. I want to know what expedited review means in this situation. Does it referencing a product in shortage go to the top of the que . Is there a special team in terms of moving the product faster . This would be a longer conversation. As im assure you are aware, weve reorganized the office of generic drugs where were elevating its importance in terms of the center for drugs. As part of that action, we are looking to be as efficient as we possibly can. I need to look back and look at the kinds of changes that office has made about their review staff. Dr. Crosse, did you have any review for a shortage proconduct product to receive expedited review status within o. G. D. . We did talk with f. D. A. About this. We are continuing our work on shortages where well look at an indepth review of the drug shortages that have been expedited and how it relates to the number of applications sitting in the queue. One issue, even when you expedite an application, if it is approved, that doesnt mean that the manufacture is ready to begin production that day and there is some concern that approving one anda may displace another drug within that manufactures facility if youre trying to move very quickly to move something to the top of the line without the sort of normal planning time. So that is something we heard about but we are looking forward further to try to get some statistics for you on how frequently f. D. A. Is moving on these applications and what proportion of the application is getting moved on. And id also be interested in how f. D. A. Works with the manufacturer to address their targets to assess when Production Capacity and output has addressed the shortage. My time has expired. The chair recognizes the gentleman, mr. Pallone, for five minutes. Id like to know how helpful youre finding the drug shortage provisions and what things you think congress should do to address drug shortages and id like to hear about f. D. A. s Strategic Plan for preventing drug shortages. I was pleased to see it was released last october in terms of your obligations. So essentially three questions. Update us in regard to drug shortages and the agencys plan to address them and now are in that fda has experience with it, are there parts of the law that does not work as intended as well as they should . Are there other areas we should be thinking about to help address the shortages . Thank you. First, let me say the provision that expanded the notification that manufacturers have been providing for us has been enormously helpful. Its hard for me to overstate that. We are learning about shortages earlier than we had previously and its giving us the opportunity to talk with manufacturers in ways that we hadnt had an opportunity before and weve been able to prevent shortages as a result. So unquestionably that aspect has been useful from the f. D. A. s perspective. We continue to make use of this. As you know, were continuing to write rulemaking and things related to it. That is fundamentally a valuable aspect of the work were doing thats very useful. The other aspects i think have been useful for us as well. The requirement to produce an annual report i think is valuable because it does give us an opportunity on an annual basis to look back and assess whether there are things we need to continue to work on or where progress has been made. Thats a piece that we were able to provide to you recently. For three quarters of the data, we obviously need to update you with the full data because we think that will give the fuller picture of the f. D. A. That activities the f. D. A. Has conducted. And so fundamentally it has been valuable to us from a shortage prevention strategy. Now you asked us whether additional things were identified in the Strategic Plan that also needed to be done. The short answer is yes. So there are many things we can do internally, there are things we can do to make sure that f. D. A. Improves our responses to the drug shortages issue. And that relates, many of them, to process. So i chair the task force. Thats been steering our response to drug shortages since the passage. That task force is made up of individuals from across the agency. So not simply my center but also the center for bilogics, the inspectional branch of the f. D. A. All of us are coming together to talk about the things we need to do, the things we need to communicate about better to be able to basically do the job more efficiently and more appropriately. We also recognize we need to improve our communications. The communications we place on the website are looked at hundreds of thousands of times by individuals looking for information about shortages. We heard loud and clear when we talked to our stakeholders that needed to be improved so that the information was easier to find, so that topical information was easier to identify. That the normal shortage, for saline shortage, for instance, was at the top of the queue, and we are trying to improve those communications. Separately, however, there are things that are as dr. Crosse said, outside of our scope, outside of the things that f. D. A. Is able to undertake. There are things that the manufacturers, we believe, have a role to explore. There are other things that other stakeholders could explore as well that have great potential, i believe, in addressing the underlying causes of shortages. Ill be happy to talk about those if you are interested. Let me ask you one more question. One of the recommendations is that f. D. A. Conduct routine analysis of the drug shortage database to identify trends and that seems like a reasonable assumption. Perhaps not a formalized process. Do you know what accomplishes will be . And recommendations for shortages. I have 15 seconds. Fundamentally, we agree with the recommendations that the g. A. O. Has made. We understand that the quality of the decisionmaking that we can have with regards to shortage depends on the quality of the data so were putting in place a new data drug shortage data system thats going to make the data more robust. Make it more standardized. I recognize the gentlelady from tennessee, mrs. Blackburn, for five minutes. Thank you, mr. Chairman. And, again, thank each of you for being here with us. I want to i got just a couple of questions. I know that the f. D. A. Report said, you know, the number of reported new shortages has declined in 2012 and for the first third quarters of 2013. But then g. A. O. Says the total number of active shortages continues to be high. So do you each agree with that . The number of new shortages has decreased and we think that the early notification has been helpful in that regard but a number of shortages have persisted across time. Ok. I think we present there information that information in our report. Dr. Thockmorton, do you think the shortages it be too high . Absolutely. Just want to be sure everyone is in complete agreement on that. What im hearing from the providers in tennessee, they agree with the g. A. O. Report. Dr. Throckmorton, they look at yours and its kind of a head scratcher because they are not seeing the kind of improvement that your report would lead people to believe is there. And we continue to hear about the shortages with the generic, sterile, injectible drug, the i. V. Fluids, the medications for anesthesia, some of the cancer therapies. So these are problems and you might be making some progress but it is not coming fast enough. And so lets talk about f. D. A. Implementing the system and preventing getting to the point they can prevent new shortages and decrease the backlog of the current shortages. So ms. Crosse, give me the couple of things that we need to be holding them responsible for doing. What is going to speed this up . Because we cant do this where were saying 10 years from now we are going to have in place. We continue to look at some of the underlying causes. I think we need to look a little more closely at those generic drug applications that are sitting at f. D. A. And the extent to which f. D. A. Has been able to expedite the applications. Which could be something that would help. But there are still a number of if i could engage you right there for just a moment. Dr. Throckmorton you said you expedited 118. Generic, yes. If you were setting a goal for him, how many should they be expediting every year, 200 . I dont know and i think there is a concern if you expedite too many then youre creating a clog at the top. Ok. Its difficult. Even within the priorities maybe approved but then they cant put it straight into manufacturing. Right. So there needs to be conversation with the manufacturers of how quickly they need to come online. So addressing them at the back end at the point of approval. Would predictability in in process with the review system because as i talked to some that are working the generic space, the biotherapeutic space, the unpredictability at the f. D. A. Seems to be a problem. Dr. Crosse, would that help . Thats not something we heard from the manufacturers, particularly. I think, you know, certainly thats always an issue in any review process, the applications, but its not something they particularly pointed to here. Because of the unpredictibility of when a shortage might occur. Dr. Throckmorton. I want to try to draw a distinction between the number of ongoing shortages that extend for longer periods of time. Thats one group of shortage that i think we know less of than we need to. The number of new shortages and the number of new shortages prevented. So when i answered your question there are too many shortages, their shortages have impact on impacts in the u. S. We would have to do away with not having too many shortages. We have to acknowledge there has been work thats been important that has been able to have new shortages adding onto that pile, if you will. We have been able to prevent shortages that matter. An important task we need to undertake is understand those longer duration shortages. Those shortages that mean no product is in the marketplace at all. There is no manufacture willing and interested in manufacturing my time has expired. I thank you for that additional explanation. Mr. Chairman, as i yield back to you, i do want to take a moment and wish happy birthday to congressman guthrie. Yield back. The chair thanks the gentlelady. [inaudible] wishes mr. Guthrie happy birthday. The chair recognizes the Ranking Member of the full committee, mr. Dingell. Im pleased the committee is turning again to the important topic of drug shortages. There are many causes for this. The availability of raw materials, complexibility of manufacturing, certain treatments, certain increases in demand. We also have a significant problem in Adequate Funding for f. D. A. And adequate number of personnel to properly address the business of that agency. While we have made some progress in that area, such as the passage of f. D. A. s safety and innovation act, which improved communication in reporting drug shortages, we all agree, more work is needed to be done. I hope the witnesses will say yes or no. The last time we held a hearing on drug shortages, the situation is dire. Is it a fact that the drug shortages quadrupled from 2005 to 2011 . Yes. Doctor, is it correct there shortagesw drug compared to 117 shortages during the year 2012, yes or no . Yes. Now, doctor, is it correct that f. D. A. s successfully prevented 170 drug shortages in 2013 . Working with manufacturers, yes. Now, dr. Crosse, although g. A. O. Used slightly different metrics, did your agency also find a decrease in new drug shortages during 2012, yes or no . Yes. Dr. Throckmorton, did the new authorities provided to the agency in f. D. A. S. I. A. Help f. D. A. Reduce drug shortages, yes or no . Yes. Will you give us information when shortages occur . Yes. Id also like to know would more personnel and more money assist f. D. A. In terms of addressing these questions . Were devoting resources we need to to this problem. And so, doctor, would you submit a short monograph on that to this committee . Yes. Dr. Throckmorton, does f. D. A. Need additional moneys to combat existing and future shortages . Would you submit the resources needed by the agency . Yes. Dr. Cross, g. A. O. s report on drug shortages makes two recommendations to f. D. A. Specifically you recommend that the agency uses drug shortage database in a more proactive manner to identify trends and patterns to help prevent shortages before they occur, is that correct . Yes. Now dr. Throckmorton, does f. D. A. Agree with this recommendation . Yes. Would you please both submit a detailed response for the record regarding how f. D. A. Could use this database more proactively and whether you need more resources to implement the recommendation . Yes. Yes. Now, i am pleased with the progress made in preventing drug shortages since the passage of f. D. A. S. I. A. We need to take a step back and look at the big picture. Fundamentally, drugs are in shortage because we simply arent making enough of them. As you know, current shortages are of generic, sterile, injectable drugs. Dr. Throckmorton, does f. D. A. Believe there is sufficient incentives to enter this market today or are more needed . Important question i cant answer without a fuller discussion and with more would you submit a proper analysis in response to this . Yes. Now, i think its time to start thinking outside the box of how we can continue to make progress on preventing these drug shortages and combating existing shortages. We need innovative ideas to help solve the problem as well as cooperation from all stakeholders. I look forward to working with my colleagues on the committee, the f. D. A. And all stakeholders on this critical issue of moving forward. Mr. Chairman, i thank you and i yield back the balance of my time. The chair thanks the gentleman. Now yields five minutes to the vice chairman of the committee, mr. Burgess, for question. Thank you, mr. Chairman. Dr. Throckmorton, we had the executive order from october of 2011 and then of course food and drug reauthorization in july of 2012. But for the casual observer to this problem of drug shortages, can you kind of just give us a thumbnail of whats being done to deal with the existing drug shortages . We have a number of things. First off, i would say existing drug shortages, especially those that have lasted for a prolonged period of time are hard. Theyre hard to resolve because the factors that have led to them have meant manufacturers have left that space entirely. So resolving those are going to require finding tools to encourage a new manufacture to decide to add a product to a manufacturing line, make a decision thats a product they can make a profit at, decide to design that line and get approvals. So those longterm shortages are things we need to explore further. Hold that thought for a second. Have the manufacturers been responsive . Manufacturers understand this issue. We have been in close discussion with many of them. Theyve identified this group, these longer term shortages we need to continue with. Dr. Crosse talked about Enforcement Discretion and you talked about exercise of regulatory flexibility. Can you give us some practical examples of where that exercise of regulatory flexibility, for example, the anesthestic drug the anesthetic drug, has there been help . Lets talk about the Nutritional Supplements that were in critical shortage recently that are use in newborn infants where its really life or death for them to get access to these medicines, those products were in limited availability because the manufacturers are having a hard time producing enough sufficient material. F. D. A. Expedited any review, all of our activities to make certain whatever the manufacture was able to provide we were able to make certain was able to serve the infants, the newborns as quickly as possible. We had examples where particulates were found were on surface required cessation of the manufacture. Because of their critical nature, we worked with the manufacturers. We worked to find filters that can be placed in line when that is administered to the patient, allowing them to continue to be used even though there is this product defect. We determined there has to be made available to the patients. We worked the manufacturers to make that happen. So that has been successful. Talk about propofol. Lack of a safe anesthetic is a big deal. With propofol, there the issue is a large faction of it comes from outside the u. S. Well over 90 is imported into the country and there have been some concerns about importation as because of some use in unapproved uses. The f. D. A. s interest, focus we had is to make sure they are using it on label, indicated in outpatient settings for anesthesia. Our work has been to work with the sponsor to make sure the patients received when it is indicated for them. Five million dosages, its an important product we are paying close attention to. The Recovery Time is so abbreviated with that as opposed to the other compounds. In the past when there was a shortage a few years ago and what we learned in that shortage was when physicians moved from that to other products they were less familiar with, you know, mistakes occurred because they were not as familiar with the dosage and how to monitor patients and things like that. So making certain that product is available is something thats very important for the u. S. Just very briefly, i heard difficulties getting proper amounts of tamiflu during this last flu season and the cost of tamiflu had really exponentially increased. Can you speak to that at all . I hadnt heard that the cost of tamiflu spiked. There were other increases in pricing, but thats not something that the f. D. A. Has the Statutory Authority over. While there were some shortages with tamiflu, we feel like they produced the amounts of tamiflu when necessary. I have questions but ill submit it. I yield to the gentlelady from the virgin islands, dr. Christensen. I want to thank you for this hearing today. While i am very happy to hear that the drug shortages are reducing, as everyone said, they still remain too high, and we know that rural areas, communities of color, territories like my district, are where well feel it the most when there is a drug shortage. I have a question that digs a little deeper of my colleague from tennessee, the vice chairs question, i think. Asking both ill start with dr. Throckmorton, but ask dr. Crosse for comment. One of the explanations i have heard for shortage was that f. D. A. Was forcing manufacturers to come up with the stateoftheart manufacturing practices, even though the old tried and true were completely adequate to ensure safety and effectiveness. The argument went that to meet the new standards, manufacturers had to shut down. I heard something thats almost the opposite the argument that f. D. A. Had been telling some companies for years that their facilities were in decline and needed to be upgraded to avoid problems in the future even though they were meeting inspection standards and eventually those warnings unfortunately came through. So dr. Throckmorton, can you comment on these two different perspectives . You mentioned in your testimony that f. D. A. Is trying to encourage industry to adopt new technologies but at the same time f. D. A. Is not raising the bar, not raising the bar in standards for existing appropriate technologies. That seems a very nuanced point. Can you just elaborate for me . Certainly. There is Quality Manufacturing that we would expect from making a tablet form, whatever. The set of standards they have in place that would quide the manufacture of product so theyre safe and Quality Manufacturing. Those things are working. And were not changing those standards at all. What we also see is there are more efficient ways to be manufacturing products, especially products that are complicated, products that are biologics, products where you want to use the stateoftheart manufacturing process where we have been working over a decade to try to help those guide drug manufacturing and make recommendations in the form of guidance and ways that manufacturers can look at to do better than the current. So were not looking to change the current acceptable processes, were looking to find a way to move towards a more efficient, a more continuous kind of manufacturing that we think offers a lot of potential for preventing shortages. Thank you. Dr. Crosse, would you like to add anything . We heard, too, the same concerns from industry and from f. D. A. The same response. F. D. A. Has moved increasingly and now under fdasia is moving to a riskbased inspection decisionmaking process to which manufacturers they should be inspecting with which frequency. The drugs that are in shortage are the sterile injectables and are inherently risky in their manufacturer and you would expect them to be a higher level of inspection of those facilities. Just because of the risk of the product. We as part of the ongoing work i mentioned before, we are going to be looking at the pattern of inspections that f. D. A. Has had across the number of years of these facilities to see if were seeing any change because it was a concern raised to us by manufacturers but the standards, as regulations have not changed. Thank you. I have a number of other questions that ill submit for the record but i have a short one. Dr. Crosse, this g. A. O. Report doesnt focus on medically important drugs. Can you tell us the trends provided in the new report are likely to product from those medically important drugs, is that something you can focus on in the future . We are very it tracks very closely. We did use a different data source. We used information from the university of utah drug Information System because they have had a database for much longer. We were able to look at trends across time. F. D. A. Didnt have a database until 2011. We wanted something that went back to 2011. 2007. The vast majority of the data that utah posed of medically necessary drugs, there is close alignment there. There are differences in the way the two f. D. A. And utah count the drugs. So the numbers may look different even though youre talking about the same drug shortage. My time is up. Thank you, mr. Chairman. The chair thanks the gentlelady. Now recognize the gentleman from illinois, mr. Shimkus, five minutes for questions. Mr. Chairman, thank you for being here. Obviously a followup to the g. A. O. Report. A few comments before i begin. Were never going to have enough money to do whatever we want to do and more people and more money assumes that will make things better but this really its important for me to always remember the whole budget pie. When 65 is mandatory spending, 35 is discretionary spending. If we dont get control over mandatory spending, spending stays the same, discretionary keeps shrinking which will affect all agencies. The military and the like. So in this budget debate, as people say, and we hear the discretionary part of the budget, we are illadvised not to always talk about the problems of mandatory spending. Id also say that f. D. A. Is one of the few agencies that got additional money through these budgetary fights than a lot of other agencies. So with that, sidney, can you put up this because a lot of the questions i think are pertaining to this thats in the g. A. O. Report. And i have it on thats why ive been playing around with my ipad. Whether its Marsha Blackburn or john dingell, i think theyve all been referring to this chart. The dark blue is ongoing shortages which began in prior years. Now i guess the first question i have so like in the 2000s, you have 40, some of those must fall off. Is that true, dr. Crosse . Thats true. Cumulative. Its not cumulative of all of them. Some drug shortages are resolved so they drop out. Those not resolved at the end of the year roll over into our data for the next year. And forgive me if i didnt read the report as closely as i should. Have from 2007, even until it was projected on the final the final bar chart which isnt finished with the fiscal year, are there pending drugs that follow that whole time period . Im not aware of any that follow the entire time period. We do have some that extended for five years. A very small number. Most drug shortages are resolved within one year or to two years, but there is a small number of shortages that have continued across multiple years. So the lighter blue portion, dr. Throckmorton, youre saying success has been made in the new shortages, right . We see that on that chart. Dr. Crosse, you have concluded there has been progress made as we see from that pending chart, correct . And thats both in the testimony . Thats correct. So thats kind of my summation. This chart is very illustrated in the report and kind of highlighted what most people talked about. I guess a couple years ago when weve been having this debate, i always wondered why the market itself doesnt respond to alleviate the shortages based upon a price signal. Now, dr. Burgess kind of mentioned, which dr. Throckmorton, you may dismiss there was a tamiflu signal sent. I dont know that. You said you didnt know that. Why, in my minute left, is there something structurally about how we either the government in its coding or its spending through medicare and medicaid or the insurance applications of purchasing drugs, is there something that distorts the market signals for shortages . Im not sure. Maybe thats something, mr. Chairman, to followup in another question in the future. Dr. Throckmorton, what do you think . I think as others have commented, the economics got to play in the decisionmaking that the manufacturers are making here. We know less about that. Speaking for myself, then we might like to. Those are important a lot of these shortages are low margin generic drugs, too, so if they are very low margin, theyre making a penny on whatever the application is and thats hard to get a price signal on a return on a major if you only have one plan operating full speed, producing all of this product. Someone said the profit on a dose is in the tens of cents. Excellent. Thank you very much. Mr. Chairman, i yield back. The chair thanks the gentleman. Now recognize the gentleman from kentucky, mr. Guthrie, for five minutes. I appreciate what the gentleman from illinois was asking. I had a High School Reunion with my friends in auburn, alabama. He was talking about the short age of drugs. He said it wasnt the expensive stuff. He couldnt do his service properly because of that. Classic price controls and economics. When theres not an ability to move the price for some reason, then you say it will be shortage and quality. Thats what you mentioned, shortage of ability and quality and there doesnt seem to be a price signal. We are not talking about hundreds of thousands or thousands of dollars. We are talking about sometimes cents and sometimes dollars. Dr. Crosse, im sorry, in your testimony you said that f. D. A. Told you that requirements that manufacturers notify the f. D. A. In advance has helped the situation, that theyre able to take some steps. While f. D. A. Is planning to establish a new Information System to track data, there are significant concerns specifically they are not conducting routine analysis of existing data, drug shortages in the database to identify or respond proactively. Can you elaborate on that point . We did have concerns about what we call eternal controls controls, to which f. D. A. Was not ensuring the accuracy in their database and they are doing broader analysis of looking at the ongoing shortages, as owe opposed to using it as a tool. To trakck status of an individual shortage. What we werent seeing was those kind of larger analyses, looking at trends. As time goes on and they have more fully developed data, we believe its important for them to engage in that and they agreed thats something they plan to start doing now they have a little more data for a little longer period of time. That that is something they can do. We talked to your earlier point about the economics. That is something we are trying to look at. There have been issues raised to us but no agreement on the source of whats holding down those prices. Well, thanks. So also, i noticed in 2011 that inspections were at their peak, f. D. A. Inspections were at their peak and shortages were at their peak. Has g. A. O. Looked at the correlation between inspections and shortages . We havent. Well go and see if there was a change across time in inspections. As i noted before, these are highrisk products. Most of these are the Sterile Injectable Drugs and where you expect f. D. A. To go to those facilities than to someplace thats making a tablet thats been in operation for a long time with a good safety record. Ok. Thanks. Drug shortages often require practitioners use alternative treatments that may not be as effective. Does f. D. A. Have alternative treatments for practitioners and patients . We have typically left that for other groups. Particularly the pharmacists with the website that dr. Crosse has been using for her data. Do identify alternative uses. Were able to identify those with other occasions. People look for other alternative therapies that may or may not be on label. We tend to use take advantage of other peoples expertise to have them do that for us. Thank you for that. Dr. Crosse, can g. A. O. Provide more detailed f. D. A. s regulatory actions to prevent or mitigate drug shortages based on your discussions . Bottom line, are f. D. A. s actions being exercised consistently . We can provide you with additional detail on what actions theyve taken. Ok. Mr. Chairman, i yield back. The chair thanks the gentleman. I yield to mr. Griffin for five minutes for questions. Thank you for being here. Sterile injectables lid to some shortages led to some Health Care Providers feeling dependent on the supposedly sterile compounded drugs that led to the fungal meningitis outbreak in 2012 that killed 62 americans, thrug two in my area. 64 americans, including two in my area. Illegal manufacturers that called themselves compounding pharmacies like necc, and thankfully congress put the f. D. A. On notice to deal with the drug shortages. Much like the drug quality and security act with compounding and illegal manufacturing. Fda officials have signaled to better predict quality issues at manufacturing facilities. Dr. Throckmorton, can you comment on these improvements . Mostly to say that we understand the importance of getting that right. So identifying what those metrics are and then having a discussion about how they would be used is very important. So our part of our ongoing efforts, efforts this coming year and beyond, speak with manufacturing experts that can talk about the kinds of measures that a plant uses to follow their own manufacturing quality. Understand those things better and then talk about how a purchaser might make use of those kinds of information. I thank you for that. One of the concerns i had, it appears in that fungal meningitis outbreak that the lawyers at f. D. A. Were not using all the powers that were available to them to oversee and while we dont want too much oversight that stops manufacturers that are doing the right things from producing their product, i hope the lawyers are being more aggressive if they see something thats out of line. While we want to have a good supply, we want to have a safe supply as well. Would you agree with that . And do you think the lawyers are being more aggressive post the outbreak of fungal meningitis . Id agree with that there needs to be a safe supply. Dr. Crosse, the agency can employ more predictive analysis to its preventive activities, how did the agency respond to this critique . F. D. A. Agreed with our recommendations and my understanding they are beginning to do it immediately. Also, the g. A. O. Report found that the f. D. A. Lacked procedures and training materials related to management and use of its existing drug shortage database. What impact has this had on the database to prevent or mitigate shortages . We think they need to have these kind of standard procedures in place to ensure the accuracy of the data and the understanding on the part of their staf