that we are required to we will not use it unless it passes those tests. >> nag you heard the earlier mentioned your testimony in the context that you and dr. equator i guess acknowledging your testimony you can take two to three years for fda to approve a no facility for epa supplier cannot he say that's not a good

>> the subcommittee will come to order. the chair recognizes himself for five minutes for an opening statement. in a 2005, 61 drug shortages were reported to the fda. by 2010, there were 178 reported drug shortages. 132 of which involved sterile

injectable drugs. so far, this year fda has continued to see an increasing number of shortages, especially those involving older sterile injected drugs. these shortages have involved cancer drugs, anesthetics used for patients undergoing surgery as well as drugs need for emergency medicine and e electrolytes need for patience on of ev feeding. it appears that there are many potential causes for the drug shortages. in some cases shortages have been caused by quality and manufacturing issues. additionally production delays at the manufactured level including limited production lines for certain older drugs and difficulty in receiving of rall materials and components from suppliers to cause drug shortages. many raw material suppliers also experience capacity problems at their facilities causing delays that ripple through the drug

production process. shortages can also result from a company discontinuing a particular drug. certain drugs are susceptible shortages particularly those of our complex to manufacture, such as an injectable drugs or require longer lead times. fda cannot compel a company to manufacture a particular drug and if there is a shortage of that drug it cannot compel others to increase their capacity. further, companies are not required to notify the fda in advance of a potential drug shortage unless the company is discontinuing a sole source. medically necessary drug. in that case a company must inform the fda six months in advance. drug shortages have real effects on a real patient is due to shortages patients have not received the appropriate drugs for their conditions often getting a less effective drug or more costly substitutes as a

result. according to a study done by the premier health care alliance of 228 hospitals, retail pharmacies and other health care facilities nearly 90% of hospitals reported a drug shortage in the last half of last year that may have caused a patient safety issue resulted in a procedural delay or cancellation required a more expensive substitute or resulted in a pharmacist compounding drug. i look forward to hearing from our witnesses today about their experiences with drug shortages and learning what remedies they believe are necessary. i would like to say a special hello to richard, vice president operations pharmacy laboratory and radiology at the lancaster general hospital in my district. it the largest employer in the 16th congressional district and for ten of the past 13 years it has been named among the top 100 hospitals in america by the leading source of of your

business intelligence. the hospital is also helping to revitalize the northwestern part of lancaster city for the partnership with franklin marshall college. again think you to the witnesses and i will yield the balance of my time to congressman shimkus from illinois. >> we want to welcome our folks in the two panels. obviously this is a concern. whenever there is a lag in a commodity good or product, you have to really wonder about the demand and the supply and the available cost because when there is a limited supply and high demand cost should go up so that begs the question of what is constraining the market signals from producing the product to consumers need is that insurance companies, is that government reimbursement rates is that the state medicaid

provision? that's what i will be looking at because the bigger the government is the more manipulative it gets in the market services and the less to provide goods and services to consumers. we appreciate that, look forward to it and i yield back my time, a researcher man. >> we recognize the ranking member of the subcommittee for five minutes. >> thank you, mr. sherman i want to thank you for holding today's hearing on this important issue. i am encouraged by the bipartisan nature and i think the witnesses for joining us. today we will discuss the recent increase in the drug shortages that have been the subject of numerous reports. the girard shortages appear to be on the rise and an alarming rate and threatening the supply of some of our most important medications from life-saving life saving on ecology drugs to antibiotics to and aesthetics to go through even the most minor surgical procedures. these drugs have become an important part of our health care system. no patient want to be told their

chemotherapy most be postponed because the only drug used to treat their cancer is unavailable. likewise, no anesthesiologist to begin their work with the realization they have to use sub-par drugs on a patient because the one they normally rely on is out of stock in definitely so we can't let this become the new norm. we've depended upon the medications on the fda drug shortage list for years and continue to look for them for the health and well-being. it's alarming the drugs that have been around for so long would suddenly be the most difficult to keep hospitals from pharmacies and doctors' offices supplied with. furthermore they tend to be a low-cost generic which are an essential component of health care for most americans as they seek to keep their health care costs low. in this fiscal climate, having a readily accessible supply of generic medications is a profound importance. and to that end, it has been disheartening to learn that the so-called market would to get

the vantage of such a dire situation to engage in price gouging at the expense of those desperate enough to pay. so i'm hoping we can begin today to identify the cause of the shortages and to discuss solutions for replenishing the drug supply. we must address this increase so that americans can continue to receive high-quality treatments at low costs and remain confident to both the pharmaceutical industry and health care providers. unfortunately companies are not currently required to report to the fda when a shortage will be occurring whether because of changes in the investment strategy or manufacturing difficulties. there is currently no policy for notification unless the company is the sole manufacturer. my colleague representative diana degette has introduced bipartisan legislation h.r. 2245, the preserving access to life-saving medications act of 2011, as a first step in addressing this issue. this legislation would require manufacturers to notify the fda

of any actual or perspective drug shortages, and i want to commend representative degette on pioneering this effort and hope that as a result of hearing from the witnesses today, we can identify additional solutions to this growing problem. this hearing will allow us to learn more about why drug shortages are occurring, with the administration and industry are doing to address the problem and what new authorities the fda might need to do to prevent shortages from happening in the future. and i am encouraged that we are exploring this issue in the subcommittee today and look forward to working with you, chairman, as we get to the bottom of this issue and again, thank you for having me here and i yield back. >> the chair recognizes the ranking member of the full committee, mr. waxman for five minutes. >> thank you, chairman pets for recognizing me and for having this hearing.

the recent media and others indicate the drug shortages are now at an unprecedented level. indeed, according to fda the number of drugs and short supply of 2010 was almost triple that of 2005. the shortages affect a broad spectrum of critically important drugs including oncology drugs to treat lynn chollet, leukemia, breast and other cancers and drugs without which surgery's have to be postponed and antibiotics to remedy life-threatening bacterial infections. without these drugs, patients' lives are at risk. drug scarcities generally affect sterile injectable drugs. these drugs are technically difficult to make and each drug is usually manufactured by only one or a handful of producers. if only one company develops manufacturing problems, which is not uncommon, other companies may have little access capacity to help fill the need to read with the aging of the population

and field sourcing of drug manufacturing, the increasing consolidation of drug companies, and the general adoption of a just-in-time approach to the drug production and distribution this problem may be significantly worse unless the media measures including congressional action not taken to address this multiple causes. representative degette has introduced legislation that would be an important first of in this process. h.r. 2245, the preserving access to life-saving medications act of 2011 would require manufacturers to notify the fda of any actual or prospective drug shortages, such events notice would enable the fda to help the volume of mitigate the shortage by those working with the manufacturer and the hospitals and physicians of the problem. weigel this is an important piece of legislation that has broad bipartisan support i don't think anyone believes it alone can solve the drug shortage

problem so i look forward to hearing from the witnesses to lead to better understand the causes of what is already a crisis for many patients, and to find out what we in congress can do to help even the shortages in the future. we already have been working in a bipartisan manner to learn about this very disturbing issue, and i trust it will continue to work together to develop and to enact legislation to help address it and address it quickly. >> thank you mr. sherman. i yield back the time. it's been in the chair thinks the gentleman and that concludes opening statements. ..

>> there's potential to impact our entire health care system, and as we discussed this problem today, we should always remember that our goal is to protect the health of people affectedded most by the -- affected most by the shortages to their pairkts and families. i say a that as a physician who cared for patients more than 30 years. according to drug evaluation and research, the number of shortages 1 rising over the last five years as you already heard, and shortages occur with any drug, generic, sterile, and injectables make a large share. in fact, in 2010, 27% of the shortages involved the older sterile

injectable agents. it includes drugs, nutrition drugs, and others used in emergency rooms. there is no >> they operate alone or together to cause a shortage. these factors include, but no r not limited to industry consolidation, major issues of quality and manufacturing challenges, changes to inventory and distribution practices, difficulty in producing a drug. we are finding solutions to

protect patients. in 1999, the fda formed the drug shortage program to monitor and mitigating potential drug shortages. when the fda becomes aware of the shortages, it works collaboratively with the affected firm to return to the usual market availability without affecting harm to the patient. although the fda does not require it, it does encourage other firms to do so. fda expedites reviews of submissions from manufacturers that include expiration products, increased capacity, use of new raw material source, license new manufacturers, and allow changes in product specifications. the fda committed to working

with drug manufacturers to prevent shortages whenever possible, and, in fact, as a direct result of this report, staff and experts across the agency, last year in 2010, 38 shortages were prevented, and so far for 20 11, this year, i'm pleased to report for the first time that 99 shortages have been prevented. also, at the same time, the fda goes to great lengths to mitigate shortages let r lessening the impact when they occur. one notable recent example involves the well described shortage of the drugs used to treat certain types of acute leukemia. kris call formation in the viles of the drug represent a quality problem that led to a disruption in production and a shortage that received tremendous publicity across the nation

within recent months. in this case, the fda worked with the manufacturers found the viles were warm, the crystals dissolved and the drug could be safely administered to the patient. as a result of this collaboration, the manufacturer was able to ship the viles to health care professionals along with a letter from the fda notifying them to inspect for crystal formation, and if present, warm the viles to dissolve crystals, and this led to ensuring and upholding patient safety. we can report today that this drug's -- this well reported drug shortage has been recently resolved. in limited circumstances, the fda can allow the temporary importation of critical drugs when l shortage is not resolved immediately, however, there's several factors limiting this option. the product may already be in short supply abroad, so importation could exacerbate the shortage.

fda has to ensure drugs from abroad meet fda quality standards. to discuss these and other possible solutions, the fda will be hosting a public meeting next month, september 26th, and this is held to gain additional insight of the causes and impacts of this challenge and possible strategies for solutions. then on friday, september 30th, the fda is conducting a webinar for the public, and this is an opportunity for people to learn more about what the fda is doing to address this challenge, and it will be a venue for citizens to ask questions 20 experts working on this topic every day. although i focused my comments until now on the fda, i should stress that the entire department of health department and human services has been fully engaged on this topic for quite some time. we view this as a pressing public health challenge, and we want to resolve this on behalf of the department and indeed the entire country. this past summer, i convened a

series of meetings with representatives from fda, national cancer institute, the cvv, center fer disease control and prevention, office of assistant secretary, the secretary of planning an evaluation, office of medicaid services, and others. we have joined together as one department to explore more deeply the root causes of this problem and the possible steps to be taken to address them. these have been productive meetings and we pledge to continue them until the problem is solved. we are committed to protecting the public health. earlier this month with senior leaders in the department hosted a meeting with over a dozen representatives from pharmaceutical manufacturers, organizations, hospitals, insurance companies, group participating entities and add vo cosigh organizations, and this meeting gave us firsthand

insight into the challenges, generated a good discussion, and also served as a foundation for our future collaboration. shortly, later on this fall, the fda releases a report with a detailed analysis of the problem with recommendations for the future and potential solutions are being examined. one suggestion is manufacturers to report impending supply disruptions with discontinuation of drugs to improve shortages and improve the drug supply. the sooner the fda learns of a shortage, the more effective they can be and notify the public and uphold patients' safety. we are committed 20 working with all parties, manufacturers, patients, and other stake holders to minimize and solve this problem. in conclusion, the department is

committed to addressing and solving this critical public health challenge. it is our goal to advance this dialogue with all interested parties both internal and external, and we also recognize and depply respect the roles of the members of congress, and we welcome the opportunity to discuss this important topic with you today. thank you very much, and we will be very happy now to take any questions you may have. >> chair thanks the gentleman doctor, why have drug shortages increased so much in the last few years? >> well, again, there's no one single reason, but there are changes here that we are seeing in the backdrop of an economic and business climate that's leading to market consolidation, a complicated manufacturing process that's being conducted increasingly in aging facilities, leading to quality

in manufacturing issues as we have heard now. sometimes products are discontinued for business reasons. it's a complicated process, so all the factors converge to create the issues we are macing right now. >> have other countries experienced shortages such as we have? >> unfortunately, the united states is not unique this this situation, and, yes, we are indeed seeing similar situations in other countries around the world. >> and when a shortage occurs in another developing country, how is that situation resolved there? >> well, we want to learn more from our colleagues there. i don't know if you want to say more about that particular issue? >> we are often contacted by our regulatory colleagues from other countries looking for -- looking to collaborate on finding solutions to particularly worldwide problems. different countries have different ways of producing

drugs -- assuring production of product, but we work as much as panel with others to make sure that shortages are limited and mitigated. >> does europe have a particular method of resolving the situation? >> i believe the method in europe is pretty much similar to ours, particularly since they have multiple countries. they look, seek other sources of supply from other countries. >> and do you know what is causing the drug shortages in these countries in europe? >> many of them are the same sorts of things. they are, you know, many of the products are marketed globally. they are not just in the u.s.. the sources of the drug substance itself are -- most of them are foreign sources, so if there's an interruption of a source in the u.s. at a u.s. plant, they -- if a source in

another country -- a manufacturer in another country has the same source, they will be in the same situation, and everyone will be out looking for alternatives at the same time. >> okay. dr. kweder what steps were taken to prevent or alleviate drug shortages? >> first, we tend to learn in terms of preventing drug shortages. we, when companies let us know that they have -- that they are experiencing a problem, it is usually a problem in prurks. sometimes it's a business decision to discontinue a product. when they inform us in advance, that's the case. we work very closely with them to understand the problem, and assess whether the shortage would be something that would be critical for patients, so, for example, if a company -- if a company is making a product that

20 other companies make, that's not likely to be critical health situation or anything, but for the injectables, that's not the case, so we'll work with the company to help them develop solutions to fix the problem and avoid an interruption in production. that is not always possible. when it's not possible and looks like the company may have to interrupt production, we go to other manufacturers, and we talk to them about their capacity to increase their production. they usually can't turn that around on a dime, but we work with them to facilitate ramping up in order to supply the market with usual sources. if it requires -- we'll work with the original company that's having a problem, we have a number of tools in our kit that

we can use to help them address the problem. you were given an example of the kinds of things we can do in some cases to look at the end product itself. if there's a problem with the end product itself, in this case, it's crystallization of the active drug, and we work with the company. they got right on the case to figure out why those kris crystals were forming, what can be done to mitigate that, inform providers, and since then, the crystal problem has been fixed. >> do you feel you need earlier warning than you currently have? >> we can always use earlier notification. there's circumstances where things happen and they are very, very unexpectedly, but the vast -- the majority of cases of shortages -- we could have been notified, and in the majority of cases we are not notified in advance.

it's getting better. i'll say it's getting better, but we still have a large percentage of actual shortages where we were not aware that it was coming. >> thank you. my time expired. chair recognizes the ranking member for five minutes for questions. >> thank you, mr. foreman. i'd like to ask unanimous consent to enter into the record the testimony of the national coalition for cancer research. i think you have a copy of it. >> without objection, so ordered. >> thank you, mr. chairman. we all agree that drug shortages are the real problem, you know, are a real problem facing the country, and, you know, from what i understand, it's getting worse, but i guess it's hard to figure out, at least for me, what the cause is, and i'd like to ask, you know, some questions bouts the root causes of the problem. the fda has said in 2010 last

year, over half the shortages were due to manufacturing and quality issues, and i understand, i think you mentioned many or a majority of those are sterile injectable drugs. why would these drugs be prone to manufacturing and product quality issues in particular? >> well, many of these products are the result of a long production process, and those production processes are now occurring in fewer manufacturing sites because of industry consolidation. there's also aging of the facilities where this work is ongoing. there are business and economic factors in the background that are lowering the profit margin, so oftentimes businesses make a decision to perhaps discontinue a particular product for business reasons, and as a result, we are seeing the quality of manufacturing issues, congress maren, that you are --

congressman, that you are referring to. some of the issues are quite disturbing where we literally are tracking products that have particlat matter like pieces of glass and metal in what should be sterile products that are injected into patients, so this is the reason why the fda upholds this mission of safe and effective drugs and also high quality drugs in the middle of this challenges environment. >> now, the next panel, the written testimony, they state it takes two or three years to get approval from a new supplier for ingredients or an alternate manufacturing site. is that true? does it take two to three years 20 get the fda approval? why is that if that is true? >> i'll start. one of the advances of the fda in this situation is to

prioritize generic drugs, expedite, and accelerate approval in every way possible particularly if the public health is threatened, so there are efforts to try to advance that time frame. that's also the goal of the generic drug user fee act under review right now, so these are issues that are very important to the fda, and they take it seriously. >> but i mean is that time period that was mentioned -- i mean, would that generally be true, and is there any kind of flexibility that you have to expedite review and inspections of new facilities to -- so they could address the shortage when it exists? >> there absolutely is flexibility, and we do that routinely when we are aware that say a new facility is needed or a new supplier is needed, and when there is a circumstance that might lead to a potential shortage of an important medical

product. we do it routinely. we can often turn things around in a matter of weeks. >> but i mean you have not answered that two or three year time span. >> sure. i'd be happy to do that. the two or three year time span is what is being referred to under usual conditions when a company -- when there is not a sharnlg situation. >> but if there is, then you deal with it quicker? >> absolutely. even the two to three year time frame, we are working and happy to see there's been an agreement on generic user fees to change that into a matter of months and not years. >> my concern is we face the extraordinary fiscal pressures and the house passed budget for fda with a 20% cut with appropriated funds. i mean, are these -- is this cut -- will that affect your ability to work with companies to avoid or mitigate shortages?

i know you mentioned generics. are you negotiating with the generic industry to develop the user fee and can that alleviate drug shortages? this is about the funding now. >> we are negotiating and have reached agreements with the generic industry about user fees, and that will be coming up for discussion by yourself, you know, within the next year. >> what about this house budget cut? >> as far as -- there's no question that resources matter, and there's -- it takes -- these are not automated processes. they take people with judgment and knowledge and having enough people makes a big difference. >> all right. thank you very much. thank you, mr. chairman. >> chair thanks the gentleman, and i want to request the following statements to be entered into the record. i think you have copies. the statement of the national community pharmacist association, the letter from the american society for hematology,

and the statement of the generic farm suital association. >> without objection, so ordered. i recognize the gentleman from illinois for five minutes. >> thank you, i think we all agree resources matter in this tough fiscal period. i think also part of the issue is priorization, and especially in life saving issues and what are agencies doing to put first things first, and what can they do to obviously redirect funds in a different direction? for -- how have cost and payment factors impacted these drug shortages 234 >> again, this is an industry that's producing

products in an environment where they are facing increasing economic pressures. the profit margin for any particular agent is declining for them, so they have to make business decisions, but also keep their products moving until the decision is made, perhaps to discontinue a product or another. throwing in the quality and manufacturing issues and delay issue contributes to the situation that we're seeing now. >> who are the big payers? >> well, there's a process where purchasers hospitals, and fashions and providers buy these products, but they are purchasing organizations and managers involved who want to drive down the price for

understandable business reasons. these are all the stake holders involved in the chain. >> i do appreciate the opening testimony because we had a series of questions, and really you answered them in the open statement which i'm just going to highlight. one of the things was, a question we were going to ask was closely collaborating, and you gave the example of the drug with the crystallization, and i thought that was very, very helpful. the other issue was alternative sponsors and using import restrictions or -- i can't read my writing -- temporarily doing something else, but you said that's constrained based upon if there was a shortage overseas of the same product which, and something that we've talked about over the past years, and with ranking members is the ability to make sure that the

dryings we're importing were inspected by our inspectors so we know the safety of that. >> right. >> i've always been a risk-based person saying on the focus point that those who are more questionable facilities ought to get a lot of looks. if they have been operating safely and they have been inspected like a #*us facility every year -- u.s. facility every year, then it might make for every two years or 18 months, and that's the issue of shifting sources too from the critical elements in safety versus known products and industries that you all have real competence in. we don't expect you to do that to industries that have a poor record, but those who are, you know, you have really good confidence in, that's the funding issue.

you also mentioned, you know, business reasons and aging facilities, and i think you mentioned increased regulations. is that part of your testimony? >> well, the quality of standards the fda puts forward in areas like this are unchanged. in fact, the fda really has gone the extra mile in my view to show tremendous regulatory flexibility here. again, since we can't require any manufacturer to do much of anything, all we can ask is for information, communication, collaborate and they show flexibility, the rewarming of the drug i mentioned, filtering

out matter so again these medications can be used and not put aside is another example. >> i have 12 seconds. >> sure. >> i'll go back to the statement of the testimony because i scribbled a comment, and i'll look at that. why doesn't a shortage of a product in this sector then send an increased price signal to manufacturers for them to then produce the good? >> well, we have come to learn that the standard economic principles of supply and demand -- >> and the question is why is that distorted? i think that's the basic fundamental question of the problem. what has distorted the fundamental principles of supply and demand and my time's expired, but i think that's the heart of the issue. i yield back my time. >> would you like to respond? >> sure, and first of all, the agreements are made often

through long term contracts, and so alaska this whole process involves multiple stake holders including the pharmacy managers and purchasing organizations, so it complicates this environment, and sort of does not make relevant the standard supply and demand economic principles we see in other businesses. >> i would say you said what i would say. thank you. >> chair thanks the gentleman and recognizes the gentlelady from illinois for five minutes. >> thank you, i'm sponsor of the degette legislation for early notification. we have a chicago based injectable drug company that has endorsed the bill, and they already do many of the things including proactively reporting to the fda about potential drug

shortages. you've explained the advantage of that early notification. let me just raise a question that some have raised about early warnings that could increase the problem and lead to hording of critical drugs. ..

what type we are talking about. is this a true product shortage or imbalance in distribution because sometimes you see things that seem to be in a shortage in one part of the country but there's plenty more so in another part. but, we will take the potential for making things worse very, very seriously. meanwhile we are working on it to access it and what we might do to mitigate if israel were usually announce the fact that it exists and try to let the public know what we are doing to try to address it. >> early notification is an what tool. >> it's a very useful tool. we see that is different than early publication. >> got it. >> let me ask you this. the fda has limited authorities.

let me run through some of those. at this point you can't require manufacturers to do this early notification. you have no authority to require companies to increase production of a drug dillinger shortage. you can't impose an allocation plan when a shortage causes life-threatening conditions and the fda has limited ability to post timely information on its website for health care professionals and patients regarding reasons for time lines for the resolution i don't really understand that one, but are there in addition to the early notification other authorities you needed that would help mitigate this problem? >> think most important are two things. the early notification is something that helps in the mitigation and prevention greatly the sure that they are

making a quality product and upholding their responsibility to produce high-quality products where a these things won't happen. our goal is to prevent even the potential from the shortage from occurring. not possible. in the case of many of these threatened shortages even as the dr. mix said these are in plants that manufacture multiple, multiple products if you look at the record of the things that led to the actual problem of production are things we've been telling the country about in routine expectations for years but only became critical whether they need to address these modernized so they could continue producing quality products without a glitch to read this first and foremost from our standpoint, assuring that we are aware so that we can step in and use every possible

communication tool and flexibility and regulatory action. >> let me just ask you to what extent is the issue of business decisions? what% of the case where we have shortages would you say this is a business decision? >> you know i can't give an exact percentage. i would be happy to provide that. >> is it a major issue and is their anything we can do about that? >> i would say that that is not the major issue. i would say by far and away the more common scenario has something to do it manufacturing and product quality. >> thanks to those of you that have been here. >> the chair thinks the gentlelady and recognizes the gentleman from kentucky for five minutes for questions. >> thank you for being here. i'm just going to follow a little long, shimkus.

you asked a lot of the questions in the opening testimony that i had a group of oncologist the other day these are people that make drugs and sell drugs and people that are fda issues or whatever these are people sort of taking care of the patients and they say they literally have to make choices about who they take care of because they don't have the drugs available so that this kind of question. i don't believe the company won't make them if you have a demand for them and they told me that these particular types of drugs are very different and the federal government said the medicare actually has price is different than other drugs is that what they were saying is true? >> i can start with that first of all thank you for your attention to the patient and this is a dire situation for the patient and i've actually tried in other fields so this is very personally and professionally in important to me. we have a rule of medicare here that reimburses according to

what is called the average sales price. so that is one factor here but we don't view that as a significant issue and attriting the shortage as we are seeing here. >> the generics are different than others. >> what we are seeing is -- you mentioned the benefit managers are driving up the drug costs they're doing it all drug costs but we see that as a particular class of drugs having a bigger problem than others and the leading i can think is different is that the way the federal government treats them they treat them different than other drugs. >> i'm not sure i can answer the question the these are generic drugs they're off patent for the most part, so they are at a point in time the profit-margin for the drugs generally because they are generic and you can have multiple manufacturers as

lower and you mentioned medicare cms but there are other group purchasers some of them are government related and others are private insurance companies that are negotiating in bulk basically for the prices and they are no different than what the federal government does. it's the same. >> why isn't that happening in other clauses? this he seems to be more than others. >> and then on generic world there is one source said there in the greater bargaining position because they are the innovator product and the have the patent. >> but there is a different system for the medicare. >> the attempt to be priced lower and that is the access point for the public. >> but if you have lower costs which are all going to drive lower-cost but you have the lower-cost then you get less

supplies because the price is lower and you have less quality of people producing so it appears there are not others, it's not a mechanism where if you just say a little bit more you are going to get the drug that is going to take care of it. there's not a price mechanism to say we have a low supply the contras mentioned this is talking about therefore if we can adjust the price we get the supply that we need to take care of the patient. >> you're raising interesting point we can get more information and work with you. >> mentioned business decisions and that's all part of the knicks but there's some things we can do. one of the things quickly the flexible teams is that relatively new reached out to some people and they did talk about some issues with inspection time and congressman

shimkus so it sounds like that is being addressed. estimate it absolutely is being addressed. >> that's good because i understand the new physicians and so we appreciate your attitude and move forward to do so so thank you. i yield back. >> the chair thinks the gentleman and recognizes the chair, the ranking member emeritus of the full committee, michigan for five minutes for questions. >> mr. chairman, thank you for your courtesy and for holding this hearing. let me begin by asking this question yes or no. do you have authority at the fda for any of the requirements with regard to efficacy from good manufacturing practices or