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May 29, 2022
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--f in fda is silent. we have not seen this as a priority in the fda and now we are. i cannot tolerate any excuses. i have one question about timing, although i think my colleagues have done a great job in talking about the various delays that were -- according to fda testimony, staff received the whistleblower report in october of 2021 and senior food staff officials did not respond to that report until four months later in february. how does that happen? how can that possibly happen and when to ask you that of the administrator? can you hear me? hello? dr. califf: i got muted. in point out that complaint was received and it was locked in right away. the or a employees did their usual review. it went to the criminal investigations unit because there was a concern that the informant needed to be questioned and brought in to go over things. issues that delayed it. i can't go into details because they are personnel related to that -- we are on record that it took too long and on top of all that, -- lack of escalation causes -- senior officials were not aware until febru
--f in fda is silent. we have not seen this as a priority in the fda and now we are. i cannot tolerate any excuses. i have one question about timing, although i think my colleagues have done a great job in talking about the various delays that were -- according to fda testimony, staff received the whistleblower report in october of 2021 and senior food staff officials did not respond to that report until four months later in february. how does that happen? how can that possibly happen and when...
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May 25, 2022
05/22
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--f in fda is silent. we have not seen this as a priority in the fda and now we are. i cannot tolerate any excuses. i have one question about timing, although i think my colleagues have done a great job in talking about the various delays that were -- according to fda testimony, staff received the whistleblower report in october of 2021 and senior food staff officials did not respond to that report until four months later in february. how does that happen? how can that possibly happen and when to ask you that of the administrator? can you hear me? hello? dr. califf: i got muted. in point out that complaint was received and it was locked in right away. the or a employees did their usual review. it went to the criminal investigations unit because there was a concern that the informant needed to be questioned and brought in to go over things. issues that delayed it. i can't go into details because they are personnel related to that -- we are on record that it took too long and on top of all that, -- lack of escalation causes -- senior officials were not aware until febru
--f in fda is silent. we have not seen this as a priority in the fda and now we are. i cannot tolerate any excuses. i have one question about timing, although i think my colleagues have done a great job in talking about the various delays that were -- according to fda testimony, staff received the whistleblower report in october of 2021 and senior food staff officials did not respond to that report until four months later in february. how does that happen? how can that possibly happen and when...
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May 18, 2022
05/22
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fda has no power to recall. it really is an issue the food and drug administration can say something is wrong with this and the public reaction to it is effectively within recall. there is no power. in hopes we could pass it when we have not been able to get it over time and other legislation that requires bipartisan vote. in terms of recall only use that term is not the power of recall it is the persuasion of companies recalling voluntarily. so you see we have a stronger hand to play here if we would be willing to do so. there is also some attitude in the country that there is plenty of supply it is just not all in the right places. there must be a computer program that tells us where that is. that is so let's get that moving a right this into the mouths of babies. we fight all the time not to take food out of the mouths of babies. some initiatives might result in. as a mother five, grandmother of nine a long time ago for me, i can still hear a baby cry, a baby is hungry a mother, a parent, dad, mom, grandpa an
fda has no power to recall. it really is an issue the food and drug administration can say something is wrong with this and the public reaction to it is effectively within recall. there is no power. in hopes we could pass it when we have not been able to get it over time and other legislation that requires bipartisan vote. in terms of recall only use that term is not the power of recall it is the persuasion of companies recalling voluntarily. so you see we have a stronger hand to play here if...
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May 27, 2022
05/22
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abbott and fda received the first report of an infant second by the coronas -- raised concerns with fda about safety issues at the facility which makes a huge amount of formula for u.s. families but it took weeks to take action on the whistleblowers complaints and months for the agency's senior leaders to see the report. a matter of life and death importance to mailroom issues. that doesn't distill confidence or explain a way that many other warnings in december fda and abbott got a second report of a child infected. sadly, that a child passed away. in january, a third report and in february a fourth complaint and a major formula recall. senator casey and i sent a letter after recalling that way back in february when we first learned of these issues. about why it took so long to respond to these reports to work with its state, federal and global partners to make this right and to make sure that it never happened again. we asked for documents about these safety issues march 10th that deadlines came and went. about the issues related to the recall including the supply of infant formula. b
abbott and fda received the first report of an infant second by the coronas -- raised concerns with fda about safety issues at the facility which makes a huge amount of formula for u.s. families but it took weeks to take action on the whistleblowers complaints and months for the agency's senior leaders to see the report. a matter of life and death importance to mailroom issues. that doesn't distill confidence or explain a way that many other warnings in december fda and abbott got a second...
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May 20, 2022
05/22
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every time the fda sits down for a meal or takes a pill, they deserve an fda that is at the top of its game. we will work with you to help modernize the fda so you can carry out your mission of protecting the health and safety of all americans. i want to thank you for being with us today and i look forward to our discussion. i wish to commend the commitment and talent at the agency of certain issues. we recognize the commission -- commitment of those who work so hard at the agency to keep our food, medical devices and prescription drugs safe. in that vein, a special shout out to the leadership and staff at the center for biologics and center for devices for the monumental efforts to get vaccines and tests for covid-19. now let me ask our distinguished acting ranking member, dr. harris, to give any opening remarks he might have and i certainly would like to recognize him at this time for that purpose. dr. harris, you are now recognized. >> thank you, chairman bishop. i also want to welcome ms. letlow to the committee and congratulate her on being a subcommittee member. we all look forwa
every time the fda sits down for a meal or takes a pill, they deserve an fda that is at the top of its game. we will work with you to help modernize the fda so you can carry out your mission of protecting the health and safety of all americans. i want to thank you for being with us today and i look forward to our discussion. i wish to commend the commitment and talent at the agency of certain issues. we recognize the commission -- commitment of those who work so hard at the agency to keep our...
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May 26, 2022
05/22
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as the fda -- is the fda shortstaffed in the food area and would this help us long? -- us along? dr. califf: the short answer is yes. i would like to make a statement about the employees that have been working hard on this night and day, getting very little sleep, very talented, but they're just not enough of them. we really do need to increase the staffing. rep. carter: -- in line >> ma, commissioner, we are going to put our money where our mouth is. we are going to get you additional funding to make sure we have those extra resources to get that plant up and running again safely and efficiently. we are also going into a conference, the american competes act, where we are looking at a host of items that are critical to national security and helping with our supply chain, boosting domestic production of critical goods for our national security, our families. medicines are part of that negotiation. when diversifying our infant formula manufacturing through the america competes act help prevent shortages like this in the future? dr. califf: absolutely. i'm privileged to be a member
as the fda -- is the fda shortstaffed in the food area and would this help us long? -- us along? dr. califf: the short answer is yes. i would like to make a statement about the employees that have been working hard on this night and day, getting very little sleep, very talented, but they're just not enough of them. we really do need to increase the staffing. rep. carter: -- in line >> ma, commissioner, we are going to put our money where our mouth is. we are going to get you additional...
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May 29, 2022
05/22
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had you heard from the fda before this? >> we are always in contact with the fda. >> where they talking about supply chain before that? >> they were not talking about supply chain, no. >> thank you very much, i yield back. >> if i were listening to your comments, i would not be very happy right now if i were looking for baby formula. all i have heard you say is, we will get a plan up by june 1 and be able to supply more -- well, we should do something to get this stuff out now. my constituents don't want to wait six to eight weeks, if that's what i heard, and then i heard mr. gerber say, don't worry too much, because we are flying and stuff from abroad. i know the biden administration is doing a lot with this defense production act they have going, but is there anything you can do to speed this up? is there something you have that could come from abroad? i will ask mr. fitz, what does this mean, with hope of working with the administration? can you expect to get to normal within six to eight weeks? let's start with mr. cala
had you heard from the fda before this? >> we are always in contact with the fda. >> where they talking about supply chain before that? >> they were not talking about supply chain, no. >> thank you very much, i yield back. >> if i were listening to your comments, i would not be very happy right now if i were looking for baby formula. all i have heard you say is, we will get a plan up by june 1 and be able to supply more -- well, we should do something to get this...
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May 18, 2022
05/22
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they have to notify the fda. and also that if we find this contamination that this is as quickly figured out how to correct it so the supply is back on the market again. these are the problems we are facing. just so you know, the hearing is next wednesday. we have the fda commissioner, the food policy and response deputy commissioner and the center for food safety director will be at next week's hearings. we have the three companies, abbott, gerber, and senior people within those organizations, those are the companies that produce about 80% of the supply. i wanted to mention that tomorrow, the committee has a full committee markup on the fda user fees and the way we pay for and authorize drugs. one of the provisions in that package makes it easier for the fda to recruit and retain holly -- highly qualified staff including areas overseas where we need inspection. i believe your appropriation bill provides for more trap -- staff and training as well. i want to thank all of my colleagues for everything we are doing
they have to notify the fda. and also that if we find this contamination that this is as quickly figured out how to correct it so the supply is back on the market again. these are the problems we are facing. just so you know, the hearing is next wednesday. we have the fda commissioner, the food policy and response deputy commissioner and the center for food safety director will be at next week's hearings. we have the three companies, abbott, gerber, and senior people within those organizations,...
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May 26, 2022
05/22
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>> should fda be aware of our struggle? yes. it shares my concern for the supply chain. >> we will help. he is looking to do that. >> as i have testified, the issues that have come up for us, we have been able to resolve. the last six months, our stock rates have averaged 68% >> retailers do address potential disruptions -- >> we reached out to our retailers to discuss with the significance of that would be. we made sure we had all the existing inventory available to us to push out to those retailers and encouraged them to push their inventory to shelf as well. since then, we have been working to increase flexibility of the programs read the wake consumer -- to increase the wic consumer's needs. finally, we have increased our efforts in manufacturing so we can get that amount to shelf much quicker. >> my time is done, but if you could respond in writing about efforts it you have taken arch -- about efforts you have taken in march. >> we recognize it is important we hear from industry manufacturers as well as government regulator
>> should fda be aware of our struggle? yes. it shares my concern for the supply chain. >> we will help. he is looking to do that. >> as i have testified, the issues that have come up for us, we have been able to resolve. the last six months, our stock rates have averaged 68% >> retailers do address potential disruptions -- >> we reached out to our retailers to discuss with the significance of that would be. we made sure we had all the existing inventory available...
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May 19, 2022
05/22
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but the fda had to go to court. they had to go to court to get an agreement with abbott about how to open. this was not a company that was taking on their culpability and knowingly selling a contaminated product that puts our babies at risk. going to court. that took up part of the lay -- part of the delay with moving, is having to go to court to do this. i would like to yield three minutes to the gentleman from new jersey, the chair of the committee on energy and commerce. and congressman paul alone has, again, spent so much of his professional career focused on food safety issues and in fact as is the ag subcommittee during hearings, the energy and commerce committee will be doing hearings on this issue as well. >> the gentleman from new jersey is recognized for three minutes. >> thank you. i rise today in strong support of the infant formula supplemental appropriations act. and i want to particularly thank appropriations chair lewin rosa delauro for all she has done to shed light on the contamination of infant fo
but the fda had to go to court. they had to go to court to get an agreement with abbott about how to open. this was not a company that was taking on their culpability and knowingly selling a contaminated product that puts our babies at risk. going to court. that took up part of the lay -- part of the delay with moving, is having to go to court to do this. i would like to yield three minutes to the gentleman from new jersey, the chair of the committee on energy and commerce. and congressman paul...
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May 26, 2022
05/22
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by the fda employees that says that the f in fda is silent. we haven't seen this as being a priority in the food and drug administration. i have just one question about timing although my think my colleagues have done a great job in talking about the various delays t that they had. according to the testimony, the staff received the whistleblower report in october. can you hear me? >> i got muted. first of all let me point out the complaint was received and logged in right away. the federal investigation unit because there were concerns. the decision was made then that the informant needed to behi questioned and brought in to go over things. if there were some issues that deflated.es i can't't go into details becaud they are personal and related to that. we are on record as saying it took too long and on top of that as i've already said the lack of escalation weree not aware until february 10th or february 9th. you have a history with food and drug administration on these food sides so we are calling you to change the focus, the emphasis to put
by the fda employees that says that the f in fda is silent. we haven't seen this as being a priority in the food and drug administration. i have just one question about timing although my think my colleagues have done a great job in talking about the various delays t that they had. according to the testimony, the staff received the whistleblower report in october. can you hear me? >> i got muted. first of all let me point out the complaint was received and logged in right away. the...
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May 19, 2022
05/22
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did you disclose that to the fda? >> we made clear in multiple instances that the individuals involved had experience in pharmaceutical -- >> they did not have experience, they were the identical humans working for both at the same time. did you tell the fda, did you make the disclosures and allow the government to decide if there was a conflict of interest? >> when we assessed the work request from the fda, we brought professionals, our legal team to understand if there was a conflict of interest. we verified the work was different. >> that is you putting yourself as the czar of conflicts. your scheme worked well for mckinsey, mckinsey got contracts, purdue got rich, and america got addicted. since 2008 mckinsey earned 140 million dollars in contracts from the fda, and you did not ever disclose your work for purdue. you did not disclose or conflict of interest. since you did not disclose her conflict of interest, will you return the $140 million to the fda? >> i will point you to the fda statement as recent as yester
did you disclose that to the fda? >> we made clear in multiple instances that the individuals involved had experience in pharmaceutical -- >> they did not have experience, they were the identical humans working for both at the same time. did you tell the fda, did you make the disclosures and allow the government to decide if there was a conflict of interest? >> when we assessed the work request from the fda, we brought professionals, our legal team to understand if there was a...
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May 18, 2022
05/22
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did you disclose that to the fda? >> we may turn multiple in foreign instances that the individuals involved had -- >> reclaiming my time. mr. sternfels, they didn't have experience. they were the identical humans working for both at the same time. did you tell the fda, did you make these disclosures and then allow the government to decide if there was a conflict of interest when we assess the work request from the fda, we brought professionals, our legal team, the dedicated government team, to understand, first, is there a conflict of interest? we verified that the work was different. >> reclaiming my time. mr. sternfels, that is you putting yourself as the czar of conflicts. your scheme worked really well for mckinsey. mckinsey got contracts. purdue got rich and america got addicted. since 2008, mckinsey earned $140 million in contracts from the fda. you did not, ever, disclose your work for purdue. you did not disclose your conflicts of interest. my question for you is, since you didn't disclose them, will you retu
did you disclose that to the fda? >> we may turn multiple in foreign instances that the individuals involved had -- >> reclaiming my time. mr. sternfels, they didn't have experience. they were the identical humans working for both at the same time. did you tell the fda, did you make these disclosures and then allow the government to decide if there was a conflict of interest when we assess the work request from the fda, we brought professionals, our legal team, the dedicated...
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May 19, 2022
05/22
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they are fda approved. those are the countries we should be going to and not just randomly, randomly, accepting applications. people do not have to have the fda approve. and let me say the $28 million, that money is mostly for the fda in terms of the inspection team. they only have nine people looking at all of the infant formula submissions. but there is a bigger issue in fda and that is the issue of leadership. it is a structure problem and they need to do something about having a person there, not a czar, sorry, i'm not for a czar, but i want the fda a regulatory agency to have someone overseas for food safety. >> i don't want to go down the rabbit hole of how long it took to get an fda commissioner. don't forget. you went through that whole timeline and what i'm thinking in my head is wait we went through this trouble to get a fda head. i want to set that aside. and you know i asked this yesterday. we have a strategic oil reserve. in 2015, we had a strategic raisin preserve. i'm not making that up. we s
they are fda approved. those are the countries we should be going to and not just randomly, randomly, accepting applications. people do not have to have the fda approve. and let me say the $28 million, that money is mostly for the fda in terms of the inspection team. they only have nine people looking at all of the infant formula submissions. but there is a bigger issue in fda and that is the issue of leadership. it is a structure problem and they need to do something about having a person...
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May 20, 2022
05/22
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the fda is culpable on dragging their feet and not holding abbott to an fda standard. both of those places are being investigated right now, and i'm engaged in that investigation, calling for an inspector general investigation but the point is that we needed to move quickly which is what we are saying. >> i'm glad to hear congress is going to be holding the fda to account. one last question. the president took measures yesterday in voting the defense production act to help with the shortage. how much of an impact using the defense production out will have in solving this problem as quickly as possible? >> i think the defense production act could have a serious effect on the production of this product, in addition to which, and i was delighted to hear that the first airlift was going to be from zurich. what we need to do, not only should we be importing project but we ought to be importing that product from fda approved facilities. we should not open the door to facilities who haven't passed the standards and the statutory requirements that the fda has. the fda does hav
the fda is culpable on dragging their feet and not holding abbott to an fda standard. both of those places are being investigated right now, and i'm engaged in that investigation, calling for an inspector general investigation but the point is that we needed to move quickly which is what we are saying. >> i'm glad to hear congress is going to be holding the fda to account. one last question. the president took measures yesterday in voting the defense production act to help with the...
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May 20, 2022
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we have a critical opportunity to invest fda -- fda facility to act with partners. there are millions of infants that rely on or miller as their sole source of nutrition. host: testifying yesterday about the baby formula shortage and he will be testifying again next week before the house energy and commerce committee. he along with manufactures of baby formulas including avid executives will be testifying on capitol hill. that's on wednesday, may 25 and you can go to www.c-span.org for more details about that. i want to show you another exchange and capitol hill yesterday on baby formula. this is from the appropriations committee chair and the fda commissioner on the agency's response last october when safety concerns about baby formula manufactured by abbott labs first came to light by whistle blower. [video clip] >> food safety is not a priority at the fda. it seems to be a restructuring of the food safety with people who know food safety. dr. woodcock was the acting commissioner when this whistleblower report reached the agency, i'm not at dr. and bacteria mutate
we have a critical opportunity to invest fda -- fda facility to act with partners. there are millions of infants that rely on or miller as their sole source of nutrition. host: testifying yesterday about the baby formula shortage and he will be testifying again next week before the house energy and commerce committee. he along with manufactures of baby formulas including avid executives will be testifying on capitol hill. that's on wednesday, may 25 and you can go to www.c-span.org for more...
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May 17, 2022
05/22
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secondly, the fda issued a statement. i was on the telephone. on the wic program, when i spoke to walmart and the major distributors yesterday, or the day before, i cannot remember, they wanted this flexibility because they did not want to be violating the law. the top issue for retailers. the fda just issued a statement about importation of formula from abroad. the fda has been looking at working with manufacturers to facilitate the incorporation of formula from abroad from places like europe where we can get more product on u.s. shelves. that is underway. it will be in a matter of weeks or less, getting more formula on shelves. the fda is ensuring and maintaining the high safety standards. host: brian dittmeier, on the importation of baby formula, is that something that is allowed under federal law? guest: one of the pieces that we are seeing out of the fda guidance is that there are a lot of barriers to importing formula in the first place. we are seeing that issue being explored by the fda and congress on what steps need to be taken to allow
secondly, the fda issued a statement. i was on the telephone. on the wic program, when i spoke to walmart and the major distributors yesterday, or the day before, i cannot remember, they wanted this flexibility because they did not want to be violating the law. the top issue for retailers. the fda just issued a statement about importation of formula from abroad. the fda has been looking at working with manufacturers to facilitate the incorporation of formula from abroad from places like europe...
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May 25, 2022
05/22
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nine people within fda were responsible for the oversight of the formula. nine workers monitoring a $3.5 billion industry that directly impacts millions of american families. they are spread way too thin and here's why that is a problem. it can take months to launch an investigation. that is exactly what happened at the plant in michigan. fda received the complaint about the factory'sd production last october they didn't physically inspect until january of this year. the fda does essential work with limited resources but it cannot serve the needs of the american consumers into families on a thin budget. if we want to truly protect the safety and well-being of families and kids we need to step up in congress. the house of representatives did it last week. house lawmakers passed rosa delauro's legislation to provide $28 million of additional funding to help the fda resolve the formula shortage and to prevent the next one. this legislation is a no-brainer from my point of view and that's why it is puzzling that 190 republican congressman voted against it, vote
nine people within fda were responsible for the oversight of the formula. nine workers monitoring a $3.5 billion industry that directly impacts millions of american families. they are spread way too thin and here's why that is a problem. it can take months to launch an investigation. that is exactly what happened at the plant in michigan. fda received the complaint about the factory'sd production last october they didn't physically inspect until january of this year. the fda does essential work...
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May 20, 2022
05/22
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the fda does have a standard. the current fda did not move to address abbott, to keep them in touch with those standards and in fact, they didn't do anything at all about that, but we have a standard, and bring the product back and get it on the shelf, and get families some sense of understanding that they can trust the product that is safe that is on the market. and they will be able to feed their babies and not cause them any harm. >> >> congresswoman, we will have to leave it, there democratic from connecticut, leading voice on this issue, thank you for your evening. >> thank you foryo highlighting the issue. >>> up t next, the house januar 6th investigators now want to question a fellow j member aboua tour he gave the day before january 6th. what do you think he is hiding? stay with us. stay with us (woman) oh. oh! hi there. you're jonathan, right? the 995 plan! yes, from colonial penn. your 995 plan fits my budget just right. excuse me? aren't you jonathan from tv, that 995 plan? yes, from colonial penn. i lo
the fda does have a standard. the current fda did not move to address abbott, to keep them in touch with those standards and in fact, they didn't do anything at all about that, but we have a standard, and bring the product back and get it on the shelf, and get families some sense of understanding that they can trust the product that is safe that is on the market. and they will be able to feed their babies and not cause them any harm. >> >> congresswoman, we will have to leave it,...
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May 20, 2022
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and then, the fda had a whistleblower, has not even as of the fda commissioner was in front of the senate didn't talk about why they didn't respond to the whistleblower report that rosa delauro put out. >> the fda, i got two heads of state. i will be brief. you going to be there? you care about heads of state? nato security, the whole thing, here is the thing. to the point of the whistleblower, there was a whistleblower in october was reported regionally and was investigated, there wasn't found to be the problem described and wasn't reported up the line. that doesn't excuse it but that is what it was. the fda writ large never received that report and that is a report that madam chair was telling us about. the federal drug administration, they had a small food budget and one of the reasons they have a small food budget with resistance from the food industry to pay the fees on the drug side that help fund the fda as i understand it and mr. paul loan talked about it the other day and this is the obstacle, on the food side, twee 8 people doing formula, really. we have to think in terms of her
and then, the fda had a whistleblower, has not even as of the fda commissioner was in front of the senate didn't talk about why they didn't respond to the whistleblower report that rosa delauro put out. >> the fda, i got two heads of state. i will be brief. you going to be there? you care about heads of state? nato security, the whole thing, here is the thing. to the point of the whistleblower, there was a whistleblower in october was reported regionally and was investigated, there wasn't...
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May 18, 2022
05/22
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and increase fda staff for inspection did the fda fail parents? >> yes the fda fell down on their job in terms of protecting babies and parents. and what we're trying to do with this legislation is to provide the infrastructure and to provide resources, funding. >> reporter: the agreement requires abbott nutrition to hire an independent inspector to evaluate the plant and install automatic sampling technology, which experts expect will be completed soon in february abbott issued a voluntary recall and closed the plant after reports of serious bacterial infections in four infants, including two deaths abbott has said there's no evidence to link its formulas to the illnesses, but with at least eight weeks until abbott's formula hits the shelf, the fda announced increased flexibilities to import formula from australia, new zealand and the united kingdom, which the agency says has similar safety inspections to the u.s. the fda telling nbc news products that can confidently meet our standards could hit u.s. stores in a matter of weeks. but parents like
and increase fda staff for inspection did the fda fail parents? >> yes the fda fell down on their job in terms of protecting babies and parents. and what we're trying to do with this legislation is to provide the infrastructure and to provide resources, funding. >> reporter: the agreement requires abbott nutrition to hire an independent inspector to evaluate the plant and install automatic sampling technology, which experts expect will be completed soon in february abbott issued a...
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May 20, 2022
05/22
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how many more illnesses and deaths were caused due to the fda? spots next question, which by the fda is the on the side of abbott. >> side of american consumer and california republican david valadao says the biden administration did not take the shortage seriously is administration appears alleviating issue. >> but it's taking too long to get to this point. >> many democrats say part of the problem when it comes to the shortage was a lack of resources at the fda, which is why yesterday we did see house democrats pass a plan to send the fda 28 million dollars in emergency funding. of course, no republicans back that legislation. they say it was unnecessary and just way too expensive for now in washington, raquel martin, back to you. thank you, rick. how? >> new today the cdc's vaccine advisory board is recommending covid boosters for children recommendation, not binding. it would still have to be approved. it comes just 2 days after the fda expanded authorization of pfizer's covid booster shot for children 5 to 11 parents could begin getting thei
how many more illnesses and deaths were caused due to the fda? spots next question, which by the fda is the on the side of abbott. >> side of american consumer and california republican david valadao says the biden administration did not take the shortage seriously is administration appears alleviating issue. >> but it's taking too long to get to this point. >> many democrats say part of the problem when it comes to the shortage was a lack of resources at the fda, which is why...
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May 19, 2022
05/22
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>> the fda is focused on safety. the reason it took the actions it did in february to shut the facility was based on a scientific regiment. now, we need abbott to move as quickly as possible to get the facility up and running. the fda has made clear the steps needed to be taken so it can run save play. abbott is committed to the steps and is moving to put them in place but they need to do so without delay. and we need other manufacturers to rob -- ramp up production as well and we have to ask hard questions about a private sector market that is dominated by three large producers that supply 90% of the infant formula in this country. we need to think about bringing more competition into this market, more entrants into the market so the american consumer is not reliant on any one private company as we are today. reporter: as you rightly point out, abbott create 40% of the u.s. infant formula that is available on shelves. millions of american families are relying on baby formula and they are dependent on a handful of co
>> the fda is focused on safety. the reason it took the actions it did in february to shut the facility was based on a scientific regiment. now, we need abbott to move as quickly as possible to get the facility up and running. the fda has made clear the steps needed to be taken so it can run save play. abbott is committed to the steps and is moving to put them in place but they need to do so without delay. and we need other manufacturers to rob -- ramp up production as well and we have to...
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May 20, 2022
05/22
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lawmakers on both sides of the aisle grilling the fda commissioner >> why did the fda not spring into action >> it was an emergency for way too long. >> reporter: commission robert califf pressed on the question millions want to know. when will formula be back on shelves. >> we should begin to see improvement within days >> so i can tell them within a matter of days they'll find formula on the shelves? >> within days it will get better but it will be a few weeks before we're back to normal. >> reporter: the biden administration facing fierce criticism for what many are calling a slow response to the crisis that's been brewing for months, after abbott, the nation's largest formula manufacturer, shut down a michigan plant in february due to contamination, snarling nationwide supply a whistle-blower raised concerns to the fda as far back as october. >> it's hard to see any evidence that fda made it a priority to get this plant cleaned, cleared, back online >> reporter: the fda giving a target date for when the plant could reopen. >> we had to wrestle this to the ground with abbott. i thi
lawmakers on both sides of the aisle grilling the fda commissioner >> why did the fda not spring into action >> it was an emergency for way too long. >> reporter: commission robert califf pressed on the question millions want to know. when will formula be back on shelves. >> we should begin to see improvement within days >> so i can tell them within a matter of days they'll find formula on the shelves? >> within days it will get better but it will be a few...
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May 19, 2022
05/22
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the audit with the fda, they lied to the fda. keep in mind, your report demonstrated this, there are only four major producers of baby formula in the united states. one of the underlying facts here is that why, in fact, do we have sole source contracting? it should be competitive. to answer your question, the fda dragged its feet. they knew in september. they knew in october through a whistleblower's report that there was serious infractions. they didn't interview the whistleblower until december. they went back in january and found contamination. the recall only occurred in february, and that was four months. why four months? there has to be answers to that question from the fda. there's got to be accountability with abbott. that is happening. that will happen. and i am investigating that. but right now, we have to deal with the shortage. let's get supply of product onto the shelves, because it's heartbreaking. jake, at least two infants died. two infants. >> yeah. >> and four are hospitalized or more. >> so i hear everything yo
the audit with the fda, they lied to the fda. keep in mind, your report demonstrated this, there are only four major producers of baby formula in the united states. one of the underlying facts here is that why, in fact, do we have sole source contracting? it should be competitive. to answer your question, the fda dragged its feet. they knew in september. they knew in october through a whistleblower's report that there was serious infractions. they didn't interview the whistleblower until...
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May 20, 2022
05/22
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yes we have to have the money for the fda to do its job. i think we will have some success. was the objection? we do not want to spend money on babies were crying for food? okay let's have that debate. >> you are fully satisfied with the administration? am. first you have to analyze how did this happen? how did this happen? where is the problem?to in the private sector which has a contract to supply all of this, or did that fall down? in the meantime you're seeking it's one thing to solve the heproblem is we go forward it is another thing in the here and now to get that baby food on the shelf. the infant formula on then she. the president has been very clear we want to be as fast as we need to be but we have to be safe and we have to be there and cautious. they have taken the steps i'm very pleased with the president did yesterday but what they have been doing is we've been going along it is never soon enough to have food for a crying baby. reporter: price gouging bill. [inaudible] what's your message to the american people right now? [inaudible] x we are doing aos number of
yes we have to have the money for the fda to do its job. i think we will have some success. was the objection? we do not want to spend money on babies were crying for food? okay let's have that debate. >> you are fully satisfied with the administration? am. first you have to analyze how did this happen? how did this happen? where is the problem?to in the private sector which has a contract to supply all of this, or did that fall down? in the meantime you're seeking it's one thing to solve...
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May 22, 2022
05/22
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but i don't know if we'll get to a fix tomorrow with the fda. the fda is quite large. but i know we have to start getting to the fix. because guess what, this is just an example of a bigger issue that we may face with something else. this time it was baby formula. but the fda regulates more than just baby formula. so we absolutely need to make sure that we should have the fda right now. >> very good point all around. panel stick around with me, we have a little bit more to discuss. still ahead, the madison cawthorn game is up. certified turbocharger, suspension and fuel injection. translation: certified goosebumps. certified from headlamp to tailpipe. that's certified head turns. and it's all backed by our unlimited mileage warranty. that means unlimited peace of mind. mercedes-benz certified pre-owned. translation: the mercedes of your dreams is closer than you think. ♪ ♪ ihoppy hour starting at $6 at 3pm only from ihop. download the app and join the rewards program today. (mom allen) verizon just gave us all a brand new iphone 13. (dad allen)y from ihop. we've be
but i don't know if we'll get to a fix tomorrow with the fda. the fda is quite large. but i know we have to start getting to the fix. because guess what, this is just an example of a bigger issue that we may face with something else. this time it was baby formula. but the fda regulates more than just baby formula. so we absolutely need to make sure that we should have the fda right now. >> very good point all around. panel stick around with me, we have a little bit more to discuss. still...
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May 22, 2022
05/22
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but i don't know if we'll get to a fix tomorrow with the fda. the fda is quite large. but i know we have to start getting to the fix. because guess what, this is just an example of a bigger issue that we may face with something else. this time it was baby formula. but the fda regulates more than just baby formula. so we absolutely need to make sure that we should have the fda right now. >> very good point all around. panel stick around with me, we have a little bit more to discuss. still ahead, the madison cawthorn game is up. horn game is up. ♪ ♪ ♪ ♪ introducing the all-new infiniti qx60. take on your wild world in style. ♪ madison cawthorn, we hardly knew you. when the north carolina republican was elected to congress in 2020, he had a promising future to some republicans. he was the youngest member elected since 1965. and i guess he had the full support of donald trump. what could possibly go wrong? well, apparently everything. cawthorn lost his reelection bid this week, losing his primary bid to state senator chuck edwards. cawthorn was mired in scandal f
but i don't know if we'll get to a fix tomorrow with the fda. the fda is quite large. but i know we have to start getting to the fix. because guess what, this is just an example of a bigger issue that we may face with something else. this time it was baby formula. but the fda regulates more than just baby formula. so we absolutely need to make sure that we should have the fda right now. >> very good point all around. panel stick around with me, we have a little bit more to discuss. still...
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May 20, 2022
05/22
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how many more illnesses and deaths were caused due to the fda? response next question, which by the fda is the on the side of habit. >> side of the american consumer. california republican david valadao says the biden administration did not take the shortage seriously. his administration appears in shun them alleviating issue. >> but it's taking too long to get to this point. >> and many democrats say part of the problem is lack of resources at the fda. it's why yesterday we saw house democrats has a plan that was in 28 million dollars in emergency funding to the fda. of course, no republicans backed that effort, they say was unnecessary and just too expensive. we watching raquel martin, back to you. rick so is congress doing anything you know, try to help with this formula problem? >> well, there is a bipartisan effort to try and help low-income families. we know and house yesterday and all still in the senate today they pass legislation to try and help wic recipients who then restricted during this be able to purchase different types of baby fo
how many more illnesses and deaths were caused due to the fda? response next question, which by the fda is the on the side of habit. >> side of the american consumer. california republican david valadao says the biden administration did not take the shortage seriously. his administration appears in shun them alleviating issue. >> but it's taking too long to get to this point. >> and many democrats say part of the problem is lack of resources at the fda. it's why yesterday we...
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May 16, 2022
05/22
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the former fda commissioner says the fda should have acted sooner to address the problems at the abbot facility. >> they were known problems with that facility going back many years or finding some previous inspections. the agency had a 34-page whistleblower report, there were data falsification and information withheld from inspectors so these should have prompted more gaggressive actio earlier. >> joining us now is dr. vivek murthy, thank you so much for being here. do you agree with dr. scott gottlieb that the fda could have acted sooner? >> it's good to be with you as well. the fda will comment certainly on what needs to happen, and a review of what's happened in the past. the most important thing we have to do right now, alisyn, is to make sure we get more formula on the shelves and make sure parents who have inpafants who need formula can get the formula to their kids. my son relied on infant formula for a while when he was younger. i know how important this is, and that's why we are all working 24/7 to make sure we increase the supply. the president has been urging manufacturers
the former fda commissioner says the fda should have acted sooner to address the problems at the abbot facility. >> they were known problems with that facility going back many years or finding some previous inspections. the agency had a 34-page whistleblower report, there were data falsification and information withheld from inspectors so these should have prompted more gaggressive actio earlier. >> joining us now is dr. vivek murthy, thank you so much for being here. do you agree...
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May 17, 2022
05/22
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kumasi: the fda is expected to authorize shots for kids by thursday. this is what parents can expect. amy: at this time next week, elementary school children could arrive at school boosted and have access in the next few days and by next week, they could be boosted, the fda is expected to authorize the booster for kids ages 5-11 in the next couple of days and they could issue shots friday or saturday of this week. some parents and teachers say having the kids boosted will help give them peace of mind. dr. say any parent who has concerns about the safety of the shot should not be worried3 >> we see note evidence of any safety issues in this age group like we haven't seen any issues of safety issues in older age groups. amy: dr. say the extra shot is effective against the delta covid darian and it doesn't -- but it doesn't work as well against omicron but it offers protections against hospitalizations and death. the state of california says children will be required to be vaccinated next year. reggie: thank you, you can pickup free covid test in antioch
kumasi: the fda is expected to authorize shots for kids by thursday. this is what parents can expect. amy: at this time next week, elementary school children could arrive at school boosted and have access in the next few days and by next week, they could be boosted, the fda is expected to authorize the booster for kids ages 5-11 in the next couple of days and they could issue shots friday or saturday of this week. some parents and teachers say having the kids boosted will help give them peace...
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May 20, 2022
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brian: well, the fda is focused on safety. and the reason why it took the actions that it did in february to shut that abbott facility was based on scientific and safety judgments. but now we need abbott to move as quickly as possible to get the fda has made very clearg. exactly the steps that need to be taken, so that it can run safely. abbott is committed to those steps and is moving to put them in place. but they need to do so without any delay. and we need other manufacturers to ramp up their production as well. and once we get through this immediate crisis, we do need to ask some hard questions about a market, a private sector market that is dominated by three large producers that supply 90% of the infant formula in this country. we need to think about how we can bring more competition into this market, more new entrants into this market, so that the american consumer is not reliant on any one private company as much as we are today. geoff: i want to draw you out on that because, as you rightly point out, abbott, they cre
brian: well, the fda is focused on safety. and the reason why it took the actions that it did in february to shut that abbott facility was based on scientific and safety judgments. but now we need abbott to move as quickly as possible to get the fda has made very clearg. exactly the steps that need to be taken, so that it can run safely. abbott is committed to those steps and is moving to put them in place. but they need to do so without any delay. and we need other manufacturers to ramp up...
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May 25, 2022
05/22
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the fda is still looking into it. what we can say about this, we have all of the elements of a concentrated markets with powerful players and we might have regulatory capture. that can cause a lapse of oversight and mishaps to occur on the regulatory side of things. the question we have to ask, why is this market so concentrated? why does abbott have this market power? if there is regulatory capture, how did this happen? if we dig deeper, there are a lot of government policies that gave them this kind of power. the trade barriers, the wic program etc.. host: this is from calvin from new york. caller: you are talking about these formulas. formulas didn't come into practice into the 60's and 70's. we existed on carnation milk. host: that is calvin. guest: as a dad myself who had a child on formula a lot of parents rely on formula, their babies need a slightly different type of food in those early days. a lot of these formulas are helpful for parents. the other thing that is important to note, you can't easily switch bac
the fda is still looking into it. what we can say about this, we have all of the elements of a concentrated markets with powerful players and we might have regulatory capture. that can cause a lapse of oversight and mishaps to occur on the regulatory side of things. the question we have to ask, why is this market so concentrated? why does abbott have this market power? if there is regulatory capture, how did this happen? if we dig deeper, there are a lot of government policies that gave them...
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May 26, 2022
05/22
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but the fda said it didn't receive the whistleblower complaint until february. four months after it got to the agency's mail room. the fda blaming the failure on the lack of staffing due to covid-19. >> literally, we're blaming the mail room that was too slow and there were decisions that were sub opt malalong the way. >> reporter: by that time, an infant had already died and two others were hospitalized after drinking formula from the abbott plant. the fda that inspected the plant in january finding egregiously unsanitariy conditions. >> bacteria growing from multiple sides and many signs in this product that are so essential to the lives of our most precious people. >> reporter: in mid-february, the fda closed the abbott facility and the formula was recalled. since then, more than 40% of baby formula has been out of stock nationwide. abbott said it will restart production early next month. but it could take eight weeks, possibly until the end of july, before store shelves are restocked. >> i'm not surprised it will take you a while to get your act together and
but the fda said it didn't receive the whistleblower complaint until february. four months after it got to the agency's mail room. the fda blaming the failure on the lack of staffing due to covid-19. >> literally, we're blaming the mail room that was too slow and there were decisions that were sub opt malalong the way. >> reporter: by that time, an infant had already died and two others were hospitalized after drinking formula from the abbott plant. the fda that inspected the plant...
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May 18, 2022
05/22
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and increase fda staff for inspection >> reporter: candidate fda fail parents in. >> yes the fda fell down on their job in terms of protecting babies and parents, and what we're trying to do with this legislation is to provide the infrastructure and to provide resources, funding >> reporter: the agreement requires abbott nutrition to hire an independent inspector to evaluate the plant and install automatic sampling technology which experts expect to be completed soon in february, abbott issued a voluntary recall and closed the plant after serious bacteria infections in infants, including two deaths abbott says there is no evidence to link its formulas to the infections but within four weeks, the fda announced increased flexibilities to import formulas from australia, new zealand and the united kingdom which have similar safety sdatandards of t u.s. they could hit u.s. stores in a matter of weeks. but parents like candace hendrix who spend every day on a quest to find formula are concerned. >> that would be one of the last options i would have i would try it if it's something c he coul
and increase fda staff for inspection >> reporter: candidate fda fail parents in. >> yes the fda fell down on their job in terms of protecting babies and parents, and what we're trying to do with this legislation is to provide the infrastructure and to provide resources, funding >> reporter: the agreement requires abbott nutrition to hire an independent inspector to evaluate the plant and install automatic sampling technology which experts expect to be completed soon in...
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May 21, 2022
05/22
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appropriately so driven by fda. what i've heard from our colleagues at the fda is that they're looking at the data they have in front of them, and that is what they're focused on. and they will make a determination as soon as they are able. and so that - and that's really - like, again, ultimately, that is what we want to hear from them - right? - that they're not going to delay, that they're not waiting for anything else, that as soon as the analysis is done, they're going to make a determination. and that's my expectation. and our job is to make sure that as soon as fda makes its determination, it'll go over to the cdc, as soon as cdc makes its determination. if the determinations are that kids should be getting these vaccines, we will make sure that those vaccines are widely available as quickly as possible for kids under five. all right. on the question of bivalent vaccines, the way to think about this is it takes about three months to manufacture these things. right? and if we want to be ready for the fall, it'
appropriately so driven by fda. what i've heard from our colleagues at the fda is that they're looking at the data they have in front of them, and that is what they're focused on. and they will make a determination as soon as they are able. and so that - and that's really - like, again, ultimately, that is what we want to hear from them - right? - that they're not going to delay, that they're not waiting for anything else, that as soon as the analysis is done, they're going to make a...
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May 27, 2022
05/22
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and the fda says there are steps the country can take to make sure shortage doesn't happen again. how can we insurer? but this doesn't happen again. i think we're going to have to have a surplus reporting in washington. i'm basil, john. next, we continue our special >> asian-american heritage. we're highlighting the journey of the bay area, professional ballet dancer, how he continues to pave the way for the next generation of dancers. and one bay area regional park district is warning residents to be on the lookout for rattlesnakes. the advite they are giving on how to stay safe. >> and coming up in east bay school placed on lockdown because of online threats against it. what police are against it. what police are saying what can i du with less asthma? with dupixent, i can du more... crazy commutes... crowd control- have a nice day alex (thanks ms. ellen) ...taking the stairs. that's how you du more with dupixent, which helps prevent asthma attacks. dupixent is not for sudden breathing problems. it's an add-on-treatment for specific types of moderate-to-severe asthma that can imp
and the fda says there are steps the country can take to make sure shortage doesn't happen again. how can we insurer? but this doesn't happen again. i think we're going to have to have a surplus reporting in washington. i'm basil, john. next, we continue our special >> asian-american heritage. we're highlighting the journey of the bay area, professional ballet dancer, how he continues to pave the way for the next generation of dancers. and one bay area regional park district is warning...
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May 17, 2022
05/22
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kristen: back to the fda approval for a booster for children five to seven years old. luz is part of our vaccine team and has what parents should keep in mind. luz: as covid cases increased throughout the country, the fda authorized a covid-19 booster for children five to 11 years old. this group would have to wait at least five months after getting vaccinated to get a booster. >> you think is necessary for this age group to get boosted? >> i think necessary depends on whether or not you believe that there is a risk. and there is definitely a risk for children.
kristen: back to the fda approval for a booster for children five to seven years old. luz is part of our vaccine team and has what parents should keep in mind. luz: as covid cases increased throughout the country, the fda authorized a covid-19 booster for children five to 11 years old. this group would have to wait at least five months after getting vaccinated to get a booster. >> you think is necessary for this age group to get boosted? >> i think necessary depends on whether or...
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May 21, 2022
05/22
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clicks on the fda under five question and this is really driven by fda and driven by fda. but i've heard from her colleagues at the fda's they're looking at the data they have in front of them and that is what they're focused on. they will make a determination as soon as they are able. that is really ultimately what we want to hear from them not going to delay they're not hearing fromn anything else seems to getet analysis omega determination that's expectation. seems to make the determination of over the cdc makes this determination if urthe determinations our kids should be getting these vaccines, we will make sure this vaccines are widely available. as quickly as possible for kids under five. quirks on the b question of vaccine the way to think about this is it takes about three months to manufacture these. if we want to be ready for the fall it's not too early to start thinking about this. in fact leave heads and preliminary conversations with the manufacturers. but the negotiations around it have not yet begun partly because were waiting for resources. the truth is ot
clicks on the fda under five question and this is really driven by fda and driven by fda. but i've heard from her colleagues at the fda's they're looking at the data they have in front of them and that is what they're focused on. they will make a determination as soon as they are able. that is really ultimately what we want to hear from them not going to delay they're not hearing fromn anything else seems to getet analysis omega determination that's expectation. seems to make the determination...