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 manufact