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Nov 16, 2012
11/12
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dr. hamburg, dr. smith, pediatricians both, we appreciate you being here, and some of the questioning, line of questioning from both sides of the dies, both republicans and democrats have been pretty tough, but they have to be because if we are going to change the law, if we're going to rewrite the federal food drug cosmetic act, particularly regard to section 503 a, the conflicting court decisions, then we have to get this right. and i have some great concerns we might not get it right in regard to overreacting in regulating compounding pharmacies. every member of the house of representatives have drugstores, chain drug stores, a lot of corner druggists that due compounding were a certain product is needed by a patient but maybe the manufactured product is in the base or something they are allergic to. so, therefore, the local pharmacist has to reconstitute of that drug, not manufactured the drug. the drug is manufactured, and just put it in a different way of getting it to the nation. it might even
dr. hamburg, dr. smith, pediatricians both, we appreciate you being here, and some of the questioning, line of questioning from both sides of the dies, both republicans and democrats have been pretty tough, but they have to be because if we are going to change the law, if we're going to rewrite the federal food drug cosmetic act, particularly regard to section 503 a, the conflicting court decisions, then we have to get this right. and i have some great concerns we might not get it right in...
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Nov 15, 2012
11/12
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CSPAN2
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dr. hamburg, dr. smith, we appreciate you being here as some of the line of questioning of both sides of the diocese republicans and democrats have been tough, but they have to be because before going to change the law, reread the federal food, drug, cosmetic act in regard to section by the 3a and the thickness of the section in the conflict in court decisions, we have to get this right. i have some great concerns that we might not get it right in regard to overreacting and regulating compounding pharmacies. every member of the house of representatives have drugstores in their matching drugstores. a lot of them just to compounding, where certain products as needed by a patient, but maybe to manufacture product is in eight days or something and they are allergic to come and sit there for the local pharmacist has to reconstitute the drug, not manufacture. the drug is manufactured. just put it in a different way of giving it to the patient. it might even be an appellate form. think hormone replacement er
dr. hamburg, dr. smith, we appreciate you being here as some of the line of questioning of both sides of the diocese republicans and democrats have been tough, but they have to be because before going to change the law, reread the federal food, drug, cosmetic act in regard to section by the 3a and the thickness of the section in the conflict in court decisions, we have to get this right. i have some great concerns that we might not get it right in regard to overreacting and regulating...
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Nov 15, 2012
11/12
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dr. hamburg we have thousands of e-mails from dr. smith agencies of the fact that you have gotten none she has less resources that they have complied to give us information so i urge you and your staff to comply. >> mr. dingell is recognized for five minutes. >> the thank you. dr. smith and commissioner is it possible for the the two of you to execute memorandums of understanding to find your respective jurisdiction, is it not? is there any reason why you could not or would not devote your attention to achieving such a memorandum of understanding so that you can define where the authorities of the food and drug lie and the authorities in the state of massachusetts like? are you going to undertake that, ladies? >> i certainly think their multiple opportunities for us to do better in terms of medication that sort of thing. >> i think you can sense from the committee, questions towards a legislative solution and it may daree well be that we have to do so and i think we are determined to do so. what i'm hoping is that while we are doing
dr. hamburg we have thousands of e-mails from dr. smith agencies of the fact that you have gotten none she has less resources that they have complied to give us information so i urge you and your staff to comply. >> mr. dingell is recognized for five minutes. >> the thank you. dr. smith and commissioner is it possible for the the two of you to execute memorandums of understanding to find your respective jurisdiction, is it not? is there any reason why you could not or would not...
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Nov 15, 2012
11/12
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WETA
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dr. peggy hamburg said her agency needs more power. dr. hamburg proposed a two-tier system where smaller, more traditional pharmacies are regulated by the state. larger pharmacies of all kinds would be overseen by the f.d.a. >> the fact that we have unclear, limited and contested authorities and ambiguities in the law, and a crazy quilt of legal authority has required us to be very reactive, responding to those serious public health threats and selective and of course every effort is research intensive. president of the new england compounding center, refused to answer questions. >> mr. chairman, on advice of counsel i respectfully decline to answer on the basis of my constitutional rights and privileges, including the fifth amendment. >> reporter: mark binkley, a pharmacist at the health and wellness compounding pharmacy in nashville, believes giving states more power to regulate is the answer. his company has been inspected by the f.d.a. in the past but is not involved in the current controversy. >> we need a higher level of inspection. w
dr. peggy hamburg said her agency needs more power. dr. hamburg proposed a two-tier system where smaller, more traditional pharmacies are regulated by the state. larger pharmacies of all kinds would be overseen by the f.d.a. >> the fact that we have unclear, limited and contested authorities and ambiguities in the law, and a crazy quilt of legal authority has required us to be very reactive, responding to those serious public health threats and selective and of course every effort is...
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Nov 17, 2012
11/12
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dr. and hamburg dr. smith. are you saying that neither the state or the fda had the authority to seize these drugs or truck this company down? -- shot this company down? >> i think it is important to understand -- >> i do not need a long -- "i think it is important to recall if the state or the fda does not have the authority, -- important." is the state or the fda does not have the authority, that is one thing, but we have a letter that says failure respond. in 2006, it was the thought that the fda had sufficient authority, and dr. smith -- she has only been on the job for three weeks, so we can not hold her libel for what happened 10 years ago, six years ago, seven years ago, but i do not think there is any question that if massachusetts felt there was a violation, they had the authority to shut it down. so, i think we ought to work on using the authority that we have as opposed to trying to get additional authority at the federal level. the fda went in and inspected this company on two occasions, and as far
dr. and hamburg dr. smith. are you saying that neither the state or the fda had the authority to seize these drugs or truck this company down? -- shot this company down? >> i think it is important to understand -- >> i do not need a long -- "i think it is important to recall if the state or the fda does not have the authority, -- important." is the state or the fda does not have the authority, that is one thing, but we have a letter that says failure respond. in 2006, it...
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Nov 14, 2012
11/12
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dr. hamburg. under current law, does the food and drug administration of the united states of america have authority over adulterated drugs? >> we have authority over adulterated drugs and we can take actions in relation to that. >> i ask that the gentleman from texas have one additional minute. >> i'm happy to yield to my friend from michigan. >> commissioner, two agencies here dropped the ball. the massachusetts agencies -- agency had to fire its head because it didn't do the job. and your agency, i don't want you dob defense -- to be defensive lew but your agency did not use your power to define who is a manufacturer. here you've got an agency that is -- that in just one has old over 17,000 doses in something like 23 states. don't you have the authority to define who is a manufacturer and who is a compounder? if you do, why didn't you do it? >> the problem is that the current legal regulatory framework says either your a compounder or you're a manufacturer. >> do they define -- you may befine b
dr. hamburg. under current law, does the food and drug administration of the united states of america have authority over adulterated drugs? >> we have authority over adulterated drugs and we can take actions in relation to that. >> i ask that the gentleman from texas have one additional minute. >> i'm happy to yield to my friend from michigan. >> commissioner, two agencies here dropped the ball. the massachusetts agencies -- agency had to fire its head because it didn't...
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Nov 14, 2012
11/12
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KPIX
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dr. margaret hamburg about why the agency dropped investigations into the trypan blue incident. and another two years earlier when at least two people developed septic shock after being injected with a drug made by n.e.c.c. we called n.e.c.c. today looking for comment. they didn't respond. the f.d.a. is out with a statement saying it needs to have its authority strengthened and is looking forward, scott, to working with congress to make sure this never happens again. >> pelley: jim, thank you. record flooding in italy has now turned deadly. we'll have the latest just ahead. what's next? he's going to apply testosterone to his underarm. axiron, the only underarm treatment for low t, can restore testosterone levels back to normal in most men. axiron is not for use in women or anyone younger than 18. axiron can transfer to others through direct contact. women, especially those who are or who may become pregnant, and children should avoid contact where axiron is applied as unexpected signs of puberty in children or changes in body hair or increased acne in women may occur. report th
dr. margaret hamburg about why the agency dropped investigations into the trypan blue incident. and another two years earlier when at least two people developed septic shock after being injected with a drug made by n.e.c.c. we called n.e.c.c. today looking for comment. they didn't respond. the f.d.a. is out with a statement saying it needs to have its authority strengthened and is looking forward, scott, to working with congress to make sure this never happens again. >> pelley: jim, thank...
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Nov 14, 2012
11/12
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WUSA
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dr. margaret hamburg said n.e.c.c. was a compounder, a company that alters drugs to meet the special needsave specific patient. she claimed that would make the state of massachusetts responsible for oversight. >> we feel there are significant gaps in our authorities. >> reporter: that didn't sit well with both republicans and democrats who pointed to evidence that n.e.c.c. was acting as a large-scale manufacturer. >> leadership is easy if you're willing to accept it, and you are not. >> reporter: but, according to the nonpartisan congressional research service, there is a regulatory gap, and if the f.d.a. is going to oversee compounding pharmacies, scott, congress must give it more authority. >> pelley: jim, thank you. a grand jury today handed down a murder indictment 33 years after america's most infamous missing child case. that's next. those little things still get you. for you, life's about her. but your erectile dysfunction - that could be a question of blood flow. cialis tadalafil for daily use helps you be read
dr. margaret hamburg said n.e.c.c. was a compounder, a company that alters drugs to meet the special needsave specific patient. she claimed that would make the state of massachusetts responsible for oversight. >> we feel there are significant gaps in our authorities. >> reporter: that didn't sit well with both republicans and democrats who pointed to evidence that n.e.c.c. was acting as a large-scale manufacturer. >> leadership is easy if you're willing to accept it, and you...
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Nov 5, 2012
11/12
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WBAL
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dr. margaret hamburg will appear before the first committee. the co-founder of the compounding center in massachusetts for the drug was distributed has been invited to testify. so far, more than 400 people were sickened by contaminated steroid shots and 29 people have died. this has probably happened to you before -- you are hungry and sleepy and grab a snack but a quick choice is usually pretty high in calories and not very healthy. now a lack of sleep can add on the pounds. >> you have heard it before -- there is a link between sleep deprivation and obesity. a new study out of the mayo clinic sheds new light. >> people who slept five hours on average compared to people who slept six or seven hours took in 550 more calories per day. >> when people are sleep deprived, they often make poor lifestyle decisions. >> people who are sleep deprived seem to take in more calories. they don't seem to expend more calories even though they are awake more of the time. >> one dietitian says get all of yourself and your habits. >> your not making good choices
dr. margaret hamburg will appear before the first committee. the co-founder of the compounding center in massachusetts for the drug was distributed has been invited to testify. so far, more than 400 people were sickened by contaminated steroid shots and 29 people have died. this has probably happened to you before -- you are hungry and sleepy and grab a snack but a quick choice is usually pretty high in calories and not very healthy. now a lack of sleep can add on the pounds. >> you have...
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Nov 15, 2012
11/12
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WTTG
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dr. ellen hamburger's pediatric practice.has been hard finding young doctors willing to work with children. >> i know that other practices in the area were part of a consortium of sick pediatric practices have had quite a bit of difficulty recruiting pediatricians if their practices. >> reporter: one study found as many ads 8.1 million children have no pediatrician in their area. the shortage is compounded by the lack of what is called pediatric subspecialists. these are the doctors that treat kids with more severe medical conditions. >> we have had great difficulty accessing -- having our patients access subspecialists in the last several years. >> reporter: while the standard wait for an appointment is two weeks, a sioux survey found children who need a pediatric subspecialist may wait seven times longer to see a doctor. there are so few specialists, some patients drive hundreds of mile just to get an appointment. >> the delays can be critical. sometimes a matter of life and death. >> reporter: take the case of 14-year-old
dr. ellen hamburger's pediatric practice.has been hard finding young doctors willing to work with children. >> i know that other practices in the area were part of a consortium of sick pediatric practices have had quite a bit of difficulty recruiting pediatricians if their practices. >> reporter: one study found as many ads 8.1 million children have no pediatrician in their area. the shortage is compounded by the lack of what is called pediatric subspecialists. these are the doctors...
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147
Nov 17, 2012
11/12
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eye 147
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dr. hamburg made. she was not there when this was beginning, and through much of the inspections that were done. the republican inspections and 2003. there was a warning letter sent in 2006. most are all of this until the outbreak was not -- host: florida, charlie. caller: i just had a couple of questions for a anna. and what the fda hearing yesterday. we have a government that regulates all of these parts of our lives. and we have pinks live in hamburgers. -- pink slime in hamburgers. we have a bp, the oil spill. you watch these hearings, and you think, all the stuff that is going on, the government is opposed to keep track of these things and they are not. my question is, if you have got a manufacturer that is sending out the files of this stuff, they're a manufacturer. i am not a pharmacist, but it is not rocket science. you are a manufacturer. guest: with the fda has said is that they did not know the volume that was coming out. did not have access to the records, is part of their argument. because
dr. hamburg made. she was not there when this was beginning, and through much of the inspections that were done. the republican inspections and 2003. there was a warning letter sent in 2006. most are all of this until the outbreak was not -- host: florida, charlie. caller: i just had a couple of questions for a anna. and what the fda hearing yesterday. we have a government that regulates all of these parts of our lives. and we have pinks live in hamburgers. -- pink slime in hamburgers. we have...