i do have a few questions of the fda. one discretion is in the case of a chemical substance, added to plastics to change their physical characteristics. the fda has yet to establish a standard for this contaminant and bottled water. an fda task force is supposedly examining the information surrounding the chemical, and i want to ask the commissioner when we can expect a ruling from your agency. the question is about recycled bottles themselves. i have had some tall made that the use of recycled bottles perhaps produces more leeching that comes out of the plastic than first time used. conducting inspections is one way that the fda is insuring that they are following restrictions. i would be curious to know the legislation passed unanimously out of the full committee that expands fda's inspection process. i would like to hear from the deputy commissioner as well on how the agency can prove the inspection process and if you need additional authorities. congress needs to act and we need to know what the agency needs to comply

> each of the supplements go back to the fda consideration. supplements often do not require human clinical testing. you are now looking at at least 15 years removed from the are original. there is not a lot of clinical data that was submitted. the idea it will function perfectly well and the manufacturer will not be liable is an interesting policy. >> thank you. >> do you have any comment about anything similar? >> it supplemental pma required for any change of any kind and is required to be approved by fda using the same standards of safety and effectiveness as the original pma > i do not want there to be any confusion about theiat. they look at the entire document. there is no distinction between the original and the supplemental pma. the fda in this instance, perhaps incorrectly, what they did was look at all the data on safety and effectiveness in humans. they concluded that the new lead did not require additional human data. i am not a scientist. i cannot say they were right or they were wrong. the doctors more qualified than i to make t

the fda did not approve all the dosages and uses. why not? as the fda told pfizer, it was concerned about the safety of the drug. the fda had noted that the drug caused an access of serious cardio problems. despite the fda decision, but pfizer marketing the same position the drug for all manner of acute pain as a complement to be c pfizer toelebrex. the pfizer marketing machine push this combination from 2002 through 2005. the marketing machine also pushed the drug for other uses. among other things, pfizer invited doctors to consult, many in resort locations. their attendance -- their expenses were paid and there were entertained with golf, massages and other activities. their job was to help pfizer the crowd how best to promote the drug for the off-label indications. the pfizer sales force claimed that the drug was a period when pfizer had not conducted any head-to-head studies between the two drugs. they had no clinical evidence that the drug was superior. claims of superiority was not supported by the label. pfizer utilize continuing medi

i represent people who work in fda. they are doing their best to come up with those ideas that either will save lives or extend lives. you have given examples of cancer and virtual colonoscopy is. where do think that came from? that came out of a lot of government-sponsored research or government doing research so that the private sector could use it. when we talk about aren't we the latest and greatest? we are in the top five of medical expenditures in the world but we are in the bottom 37 in terms of health outcomes. the whole idea of what is coming out of comparative effectiveness is to enable more evidence in the practice to -- evidence informed practice to occur. the people who are going to be providing a lot of this research will be coming from these iconic institutions in our country. they are iconic, that they are known around the world as incredible institutions. we are finding it convenient to turn to the institution of medicine to do a study, but when we are talking about comparative effectiveness we call the

fda officials say they will crackdown on misleading food labels. the food industry started putting smart choice labels on that may not be nutritious. the fda is developing nutritional standards and says products would have to meet its standards before labeled as healthy or smart choices. >>> take a close look at this video with me. this is video of a man -- there he went thank goodness. nearly flattened by a bus in russia. he sprints for his life after that bus nearly misses him. it hit about 14 more cars before it came to a stop. there were some minor injuries. bus officials think the brakes failed. unbelievable. >>> if you are an attractive man looking for your pick of the ladies, they say head to el paso, texas. a poll on total beaut.com is claiming that el paso, sorry guys is thing ye ing yoing ye i country. many there disagree. >> they say we have the ugliest guys. >> that might be right. >> you could find them anywhere you go. >> i don't think we're that ugly here. >> not true. >> you're a good looking guy. that offends you? >> are you seriou

. >> [inaudible] the white house pressure the fda to send this letter to help kill the -- the fda is not denying it. the senator stands by his charge. >> i would say that concerns by the fda about reinterpretation are not something that came with the obama administration. if one can do this safely, it was the concern of the fda to the prior administration, so this is about 810-year concern by the fda in terms of safety. -- this is about a 10-year concern. if you look back at the history of concerns that have been had about safety, they have been there for quite some time. happy holidays. >> [inaudible] >> no, enjoy your holidays. >> [inaudible] >> i have not seen that information. thanks. >> a question for robert gibbs about parker griffith. news that parker griffith, a freshman democrat will announce he is switching parties to become a republican. that will take place this afternoon in his district in northern alabama. the senate is in day 19 of debate on health care legislation. democrats passed the bill through procedural votes this morning, paving the way for more debate, althoug

i can assure you that you will need all the horses with the fda pulling hard. that is not the case, you have my phone number. >> capt., alpa said the chairmen. i commend you on the aggressive safety agenda. what is your plan to balance that with promoting air safety? we all know that the two primary missions are to promote air travel and to promote air safety. how do you plan on balancing that to a better degree that your predecessors? >> congress sought a little that for us. -- solve a little bit of that for us. it is not an obligation for us to promote -- interestingly, it is for space travel, but not for commercial, and i am not making that up. [laughter] what i want to do, i think this is an area where you will see me working there, i will ask you to help me work there -- it always troubles may, when i sat in this seat and when i sat in this seat -- i have proof that if you stick around long enough, it is like an airline, you get to sit in all the seats -- and it troubles me that last year we carried 753 million people, conducted 73,000 operations every sin

the fda has been hampered by lack of resources. they do not have full authority to do the things that we expect them to do. they have not had the leadership they have needed. there is a new leadership there. this new safety bill will get of more money to the fda to do the job of making sure that our food is safe. we want to make sure that the food producers check that there are no harmful substances in our food. i think it will be a plus and labeling is worthwhile because i think consumers are entitled to know. i believe in the concept of the right to know. host: from new york, the republican line -- are you there? caller: i have two issues with you. first, have you checked out vauxhall, the general motors family company, where their cars get between 50 miles per gallon and 60 miles per gallon ta --? what is the bill doing to get us off of oil? guest: want the largest use of foils for a motor vehicle. we have strong incentives to produce cars that use less or no oil. we're trying to produce electric cars, hybrid cars, and all the i

the fda is not denying it. the senator stands by his charge. . this is a 10-year concern. the notion that this crop up in the last couple of weeks, those notions about safety have been there for quite some time. happy holidays, guys. >> [unintelligible] >> enjoy your holidays. thank you. i cannot even tell you -- no. >> [unintelligible] any comment? >> i have not seen that information. thanks. >> also at the white house today, president obama met with several small community bank ceo's. his remarks to reporters after that confirmed that he would stay at the white house until the senate completes its work on health care legislation. >> all right, everybody. it is good to see all of you. i just completed a meeting with 12 regional community banks to have the same conversation i had with some of the larger banks last week and i have been having with ceo's from companies across the country over the last year. that is, how do we continue to sell a baby gains we have made during the course of this -- continue to consolidate the gains we've made during the course of this year? so

the group wants the fda to do more to inspect these foods. the produce industry issued a response saying -- >>> if you use the internet or you take pictures with a digital camera, you have this years recipients of the nobel prize in physics to thank. three men won it for their 1960s research. fiber optics was pioneered and figured out how to transmit light signals. and the digital camera's electronic eye. >>> what was supposed to be a calm and relaxing ride turned into a frightening painful experience. see what happened after this hot air balloon accident. >>> police are cracking down on protesters in turkey. protesters broke store windows before rushing for cover. there were a couple blocks from the meeting of the international monetary fund and the world bank in istanbul discussing the economic collapse that hit turkey especially hard. >>> encouraging news for crews fighting the massive 7,000 acre wildfire in southern california in san bernardino county. forecasters not only expect cooler temperatures, higher humidity and light winds. those

pfizer was alleged to have deceptively marketed drugs for purposes which were not approved by the fda. those actions put patients at risk, cause heart attacks, and death. in addition, allegations of kickbacks to doctors. the subsidiaries pled guilty. we found multiple year schemes to advance the marketing of drugs for purposes which had not been approved by the fda. host: a company like pfizer or eli lilly, do they set out in their board rooms to commit fraud? guest: i do not thing we have ever had someone be as explicit as say it is a crime and i'm looking forward to committee it, but they clearly understand the parameters of the law. in the case of pfizer, they understand that the fda says you cannot market this drug for acute pain, and they went ahead and did it anyway because it increase market share in profits. i would say that executives at pfizer knew what they were doing was illegal. host: before we go to the colors, are the loaws too vagues? guest: the criminal element those very quickly parade organized criminals have come into this arena. it's a lot safer than dealing crack

the group wantsed fda to do more to inspect this. there is a response from the produce industry. his is the response. the produce industry is 100% committed to providing safe produce every bite every time. our livelihoods depend on it. the statement goes on to say did is never in consumers' best interests to scare them away from the very foods that we should all be eating more of for our better health and healthier weight. >>> let's keep talking about eating here. posting calories on menus in restaurant chains does not change what people eat. a new york city law required calorie counts from lots of foods, particularly fast food vendors, they have to post it. researchers observed customers in mcdonald's, wendy's, kfc and burger king and four city neighborhoods with high obesity and also diabetes rates and found only half of the customers noticed the calorie counts. about 1/4 said it did influence what they ordered. only about 1/4. health add co-kits say it suggests they're more interested in cost than calories. >>> encouraging news for those crews fighting the massive 7,000 acre w

>> the fda is looking for closely. that's good news because a lot of nutritionists said what is goggin here, when we were telling about what's going on with the smart choice labels. they wanted to try and make things uniform before each different company had their own icon, it was pretty confusing, so they're trying to do a good thing. but is it necessarily working with if mayonnaise and sugary cereal gets the label. the product would have to meet the government's standards before it could be labeled as healthy or a smart choice. when you see mayo saying it's healthy, you wonder. there's usually a lot of fat in it. >> the same issue about those little labels with appliances. >> yes, can you trust industries to you know--their job, their mission is to look out for their stock hoeders not for you. >> tell me how you feel, jen. >> that's their stated mission. >>> all right, your money, the $700 billion bailout it may have avoided a great depression, but at what price? that's from the man who's in charge of tracking the ba

the fda says absolutely do not buy any treatments you see for sale online. the agency is warninging it's now testing products found on the internet that claim they can help and so far none of them have been approved in the u.s. the bottom line talk to your doctor. >>> the latest on a dying texas woman who may have her power shut off. she needs electricity to keep breathing through an oxygen ma seen. the power company has threatened to turn it off after falling behind on her payments. politicians want to change the law to allow exceptions for customers like her. >> she's defined as a critical care customer. >> they say they welcome the opportunity to improve. they were very responsive to complaints from the utilities commission. people are responding, a lot of them, to this woman's story. hundreds have volunteered to help pay her electricity bill. >>> heart stopping video. a baby carriage falls in front of a moving train. we're going to show you that just ahead and tell you how it turned out. first, how to stay fit? nfl style. >>> there's no question for nfl

it is the last step before it could go to the fda for approval. this is designed to stimulate the immune system and prevent nicotine from entering the brain. a possible vaccine, wow. >>> live to this picture right here. people infected with the h1n1 virus could get paid sick leave. senator chris dodd is proposing the idea this morning at a live hearing you see here on the costs of the flu outbreak. the plan is intended to keep sick workers home so they do not spread the virus in the workplace. it would also help parents take care of infected kids or deal with school closings. we're listening to that. we'll get you an update if there are any developments. >>> some people who lost loved ones in the d.c. area sniper shootings planned to watch john muhammad's execution tonight but none of his family will be in the room. why one of his ex-wives, though, says she felt guilty when the shootings first happened. >>> the d.c. sniper john allen muhammad is scheduled to die tonight. ten people died in the 2002 shooting spree but his second wife believes she w

agriculture, will develop and fda, and related agencies. . a communication from the speaker. the clerk: the speaker's room, washington, d.c., july 9, 2009. i hereby appoint the honorable ed pastor to act as speaker pro tempore on this day. signed, nancy pelosi, speaker of the house of representatives. the speaker pro tempore: the prayer will be offered by our guest chaplain, mount erie baptist church, bridgeport, connecticut. the chaplain: let us pray. good morning, god, our creator, provider and sustainer. it is to you our refuge, strength, the one god who is known by many names. to you, god, we give thanks to this day, a day in which we have another chance to manifest your divine essence upon the earth. you have given us another opportunity to demonstrate your love for us in how we treat one another. and so on today i lift the members and staff of this the united states house of representatives. i pray your wisdom and guidance will consume them so that they will understand the individuals, families and, yes, even the nations that will be impacted by their decisions today. s

the position of coming up with the additional warnings that also have been put on the label that the fda didn't think of asking the manufacturer to actually put on the label. this case is significant. it was a headline case. it was very important for the business community which, when it's convenient finds that there's a lot to be said for the federal state balance, and it just points to a great deal of instability going forward in the preemption doctrine of the supreme court. there are many ways in which this case cannot reasonably be distinguished from the gire case which was some years ago and involved car safety, and that's going to be a very important area going forward. we don't know how the new justice will affect it? we don't know how it will affect it now that justice thomas is on the team given the leeway to the states in this area. that's all i have. >> on time. >> i'm watching the clock. >> good. good. neil? >> i want to begin by thanking todd and the heritage foundation for having me here. i'm privileged here. you heard miguel was assistant general of 1992 to 1997 and in 199

. >> my name is michelle marcoses and i am a former fda employee. my question is about the insurance companies, they pay a lot of money to buy votes in congress and i think maybe something like the mccain-fine gold might be applicable to set limits that could be burned with your money. >> the question was, the insurance companies, aren't they making a lot of money and are they also spreading a lot of lobbying money to members of congress? clearly, the insurance industry does not want competition. clearly the insurance company is benefiting from the system right now. the way they're doing that is, frankly, the denial of care. we just talked a little bit about rationing during the bill does not ration health care. the fact of the matter is, though, if you had to be exposed to private insurers, you know that they very frequently denied care and they are frequently whimsical, with capricious reasons and they jeopardize lives, in some cases. i repeat a statistic, the profit of the insurance industry, the top 10 in jurors in the country that dominate 90%

the raid was part of an investigation by the fda. according to court papers, this site sold substances that are illegal. the site is owned by the same company that owned the atlanta braves. liberty media bought the team in 2007. they also own a stake in directv and ticketmaster. we haven't heard from them about this story. >>> it was a picture-perfect day of golf in atlanta. the first round of the final leg of the fedex cup with $10 million on the line. phil mickelson there. tiger woods finished the day second behind this man, sean o'hair, who was probably in the league because of some advice tiger gave him. and skiing bad boy brodie miller is doing a 180. he is rejoining the u.s. ski team and hopes to qualify for the 2010 olympicsvancouver. this is after the two-time world champion had been racing independently after clashing with the u.s. team. miller seemed to express remorse for his behavior in the past when he was just unapologetic while partying while competing in italy a couple of years ago. >>> time for our true champion. thi

we are told that because of fda rules, 90 days notice was required before the systems could be modified to remove the infections and vulnerabilities. in some cases, there can be a disconnect between government rules, which are meant to protect consumers, and today's cyber threats, which sometimes results in entering and delaying the ability to fix problems in the medical system. based on my long experience, one of the most important areas for congress to concentrate on is improving the communication but between the public and private sectors and across the sectors. the department of homeland security access a liaison between the public and private sectors. it is a woefully understaffed and underfunded for the enormous task that is put before it. i would like to see more focus collaboration, as dan had mentioned, and in summary, we face enormous threats from more parts of cyberspace. beyond the normal traditional resources, we need to concentrate on improving the collaboration between industry and government. mr. chairman, thank you for the opportunity to address you and the rest of the

in addition to the finding that may be needed, i think the fda should work with agencies to maurer effectively use the resources they already have. -- work with agencies to more effectively use the resources they already have. i know there is a lot of interest in and different views on how to modify the existing modernization fund. i don't want this hearing to become a squabble between transit systems, but i would like to have input. there were several agencies that wished to participate but could not. i welcome them to provide input on the committee in writing. we need a better understanding of the definition of state of repair is. we also need to develop a system to report the condition of transit access. we do not want these systems to be bogged down in red tape, but it appears we need more information and transparency. i look forward to hearing from all of you, starting off with our distinguished administrator of the transit administration. before i turn to the administrator and my distinguished colleague from hawaii, if there was any statement you would like to make at this time. >> i wan

components that are continually interacting with each other, such as the center for disease control, cdc, fda, nih, a variety of other groups. we are working closely with the department of education because this involves schools, the department of homeland security, and the white house. the cdc has a close connection with state and territorial health officials, so the link between the federal government and what goes on at the local level is very strongly channeled through the cbc. so it really is a nice network that talks to each other and interdigitate quite well. host: if you are a parent or pregnant or any one of the five groups that you recommended getting the shot, who should you be calling? guest: it is the local level. we just described the change that goes down from health and human services to education to state and local officials. the local health authorities in a state or a city are the people who will be responsible for how this is going to be distributed? where can i get my vaccine? what should i do vis a vis the schools? in a pinch, the website for the cdc is really terrific.

we're working closely with scientists at the national institutes of health, the cdc, the fda, working actively to make sure that an h1n1 vaccine is safe and effective as possible. we know that the health departments will be the best information source for regular information, and we anticipate the same kind of outbreak that we saw in the spring, which is that, in some areas, there may be a lot of flu, and and in some areas, there is really little. it is hard to predict in advance with that will look like. so staying in touch of local health departments, as an employer, is a way to make sure can monitor responses carefully. flu conditions change rapidly. what we saw this spring is that day-to-date changes are quite dramatic. so local public health officials have the best pulse on the situation. human-resources and leave policies definitely need to be as flexible as possible. hopefully will follow public guidance. so letting employees stay home and the cdc guidance is 24 hours after the fever ceases is the time to stay home. that will vary from person to person. some people may have a t

the fda has alerted other hospitals but ge which made the machine says it's not defective. >>> the pilot that pulled off that amazing landing on the hudson river has a book out now. it's titled "highest duty my search for what really matters." usa today says it describes his personal and professional life and how his mom saved money for flying lessons and how he wooed his wife. >>> after all the talk about health care, a critical vote will begin in 15 minutes and one woman is the center of attention in today's vote. you'll find out who she is and why her vote is so important. live to the hill. >>> well, the attorney for a u.s. dad says his client is being mistreated in a tokyo jail. the attorney claim christopher is being held without trial and denied treatment for high blood pressure and exposed to sleep deprivation. he is accused of kidnapping his kids after his ex-wife took them to japan. a u.s. court had granted him sole custody but that's not recognized under japanese law. >>> now to a crucial vote today that could shape your health care for decades. live pictures at the moment. the

is there anything in section 931 that would take away the authority of the fda to regulate drugs or devices? >> is there anything under this that would change the regulatory scheme for dangerous drugs or schedule drugs? >> no, certification. >> is there anything in this section that deals with changing the scope of practices to what a nurse or doctor can do? >> under other existing statutes, and no. >> not under this one. >> if there are authorities under existing statutes, they would remain unchanged by this. >> this amendment the when not change to the law -- would not change a lot? >> the main of the current law on these topics. -- there may not be current law on these topics. this amendment would not change those other statues. >> thank you. >> time is expired. >> i move to strike the last word. on the issue of caps, if you read the bill, a lifetime limit on caps has been lifted, and this is a very important provision in the bill. in 1996, and the interest legislation and called christopher reeve and asked if he would allow his name to be placed on the bill. he was a very good example o