tv [untitled] CSPAN June 18, 2009 5:30pm-6:00pm EDT
the presiding officer: the senator from ohio. mr. brown: thank you, madam president. i ask unanimous consent to dispense with the quorum. the presiding officer: without objection. mr. brown: and, madam president, i ask unanimous consent to speak as if in morning business. the presiding officer: without objection.
mr. brown: thank you, madam president. as members of the senate and the house tackle health reform, two overriding objectives have become apparent cloob we must bring down costs and we must expand access while allowing people who are happy with their health chair to stay in the plan that they're in now. bring down cost, expand access, fix what's broken, preserve what works. perhaps nowhere are these needs more obvious -- to bring down cost and expand access -- than in the area of biopharmaceuticals or so-called biologics. they are the fastest-growing segment of prescription drug spending in the united states. with costs of biologics ranging anywhere from $10,000 to $200,000 per patient per year, biologic treatments pose a significant financial challenge for patients, for the insurance companies, for employers who are paying the bills, and for federal and state governments
who are also paying the bills. let me give you a some examples. if you suffer from an inflammatory condition like chrohn's disease or arthritis, you'd probably be prescribed inbro or rimicaid. they cost more than $1,000 a month. you know twha does to an individual's pocketbook, you know what that does to an insurer, an employer, or taxpayers. if you're diagnosed with multiple sclerosis, 200 americans every week -- some 30 americans every day -- are diagnosed with multiple sclerosis. you'd probably be prescribed an interferon-like avenex or ribeth. the cost is $19 that per year. if you need zephelin to treat lymphoma which strikes 75,000 americans a year, that costs up to $35,000 a year for a -- or $30,000 for a full round of
treatment. when other prescription drugs go off-patent -- that is, after they've had patent protections for many, many years -- when other prescription drugs go off-patent, there's a process at the food and drug administration for approving lower-cost general flashing versions of these drugs. so you'll see when you go to a drugstore many drugs which now are off-patent. they've provided good profits for the developer and the drug company, but they are a now off-patent, so there can be generic competition in many of the drugs we use, we know that happens. that's work to keep the price down to bring competition to the state. to bring competition to the industry. but no such process for generics exists for -- no such process for biologics existings, no allowance of a generic substitute to compete with a buy lodge iefnlg it is a stand, biologic manufacturers are in the envyious position of having a permanent monopoly, no one can
compete with them. even after their patents expire, f.d.a. under law can be legally approve competing products because of a gap in f.d.a. law at this point, the only thing that stands in the way of establishing a generic approval process for biologics is, you guessed it, the political muscle of the biologics industry. here's what the industry tells us: they don't want any kind of approval process for generic biologics. they don't want competition. they want to continue to charge $14,000 if you have chrohn's disease. they want to continue to charges $19,000 if of u. you have m.s. they wnts to continue to charge to the 75,000 americans who have limo if a, some $30,000 for a round of zephelin. but if we do create a process, they want to create a permanent patent extension. maybe you give them a 12-year -- after 12 years you allow a generic, unless they slightly
change a molecule or a process and you get another 12 years and another 12 years and another 12 years. so in addition to 20 years' worth of patent protection, this athey now have, they want 12 years of market exclusivity which has the exact same effect as patent protection. they get 20 year, then another 12. then when f.d.a. grants a drug market exclusivity, it means that f.d.a. will not approve any generic version of that drug, period. after the first 12 years of market exclusivity is over, the biologics industry want to be able to slightly modify their products, just a slight modification, and they get another 12 years of market exclusivity. and if they slightly modify their product again, they want another 12 years and another 12 years. in other words, madam president, they want no generic competition. we have generic competition in all kinds of drugs that are very, very well-known, for pharmaceuticals. but there is no provision for any kind of generic competition for these biologics.
the federal trade commission, a government report with no skin in the came, with no belief that one product is better than than another, with no ties to the drug industry, the f.t.c. issue add report asserting that the biologic industry gets plenty of marketplace protection through patents and they shouldn't be afforded even one day of market exclusivity, much less 12 or 24 or 36 years. aarp recently reported that the top ten biologics recoup their r&d effort after two years of sales. they claim they need decades sometimes to recoup their investment. the aarp doesn't make this stuff up. biologics manufacturers, even though aarp said they only need two years of sales to recoup their investment and give them more time than that, so they can make a healthy profit. they should. yet biologics manufacturers are asking for 20 years of patent
protection coupled with 12 more years of market exclusivity, again renewed over and over and over again. that's the way they like t the biologics industry wants us to go home and tell our constituents -- wants you to go home to shrks madam president, tell your constituents who have cancer or multiple sclerosis or numerous other conditions now treated by biologics, that if they're lucky, in 24 or 36 years they'll have access to these biologics that are more affordable f we care about patients and fiscal responsibility, we won't allow the biologics industry to bully us into giving them more marketplace protection than any other industry in the planet. but it will take the personal will of members from both sides of the aisle to overcome the biologic industry's clout. some members of this body have already taken a stand. i want to -- i was prude to join senator schumer, a democrat, senator collins, a republican, senator vitter, a republican, to introduce legislation -- senator
bingaman also, a dernlings -- to introduce legislation that would close the gap in f.d.a. laws that permits this. this legislation is a compromise. it would provide five years -- rerks they already have their patent protection. five years of market exclusivity to buy logic, the same as that provided to other prescription drugs. then they would be eligible, the manufacturer of the biologic, for an additional three years of market exclusivity for beneficial changes to their products and even more exclusivity if they conduct pediatric tests on their products. this tiered approach, which i hope to include as part of the health care reform bill moving through the "help" committee, would provide needed competition, long-term savings, and an opportunity for consumers to have safe, effective, and affordable medical treatments. biologics -- and i credit the manufacturers and the scientists and thank them -- the medical researchers -- for this they provide great promise and they provide hope to those suffering from devastating diseases and
chronic illness. but absent price competition, how can -- countless americans will be unable to benefit from these medicines because they're just too expensive. when you're talking about tens of thousands of dollars a year just for this drug treatment, this biologic treatment, let alone all the other doctors' bills and medicine that they they'd. i hope that when my colleagues are lobbied by the industry and they're spending millions of dollars on this because this means hundreds of millions of dollars and more profits for them, i hope when my colleagues are lobbied by the biologic industry that you will remember 12 plus 12 plus 12 plus 12 simply doesn't work for us. american patients, american businesses, american taxpayers can't afford to wait 12 or 24 or 36 years for affordable biologics, and frankly, madam president, we should not make them. i yield the floor.
a senator: madam president? the presiding officer: the senator from delaware. mr. kaufman: i ask consent to speak in morning business for up to ten minutes. the presiding officer: without objection. mr. kaufman: madam president, i've spoken here a few times already about federal employees and the great work they perform. i'm honored to be in a position to come here and do it again. i enjoy sharing stories about excellent public servants. the stories are not only a -- are only but a few pieces in the vivid mosaic of our federal workforce. the stories are exemplary, not exceptional. these are regular people doing a great job. the real story of our federal employees and that of their dedication, their talents and important contribution needs to be told. service in government is characterized by sacrifice. many of our federal employees wear a uniform and sacrifice in the battlefield. others work in civilian jobs but
still make great sacrifices by working long hours and foregoing opportunities in the private sector, such as substantially better pay and bonuses. their bonus, as i've said before, is the satisfaction of having served their country. today i wish to speak about a man who risked his life during wartime and then spent nearly decades working as a civilian engineer for the u.s. army pheufpl command. joe cononton, a native of tuscaloosa, alabama served as a navigator, bomb dear on 47 missions in the european and pacific theaters. joe was decorated with three medals and four battle stars. hisnit received an award for support provided the french expeditionary force in italy. after returning home joe took advantage of the g.i. bill to pursue a bachelor of science degree in chemical engineering from the university of alabama.
he began working for the university army missile command in huntsville in the late 1950's. for 27 years joe worked for the army missile command's research, development and engineering division at red stone arsenal. he and his engineering team helped develop and perfect weapons systems critical to maintaining our military edge during the cold war. this included the lance, helfar and thaad missile propulsion systems. when joe and his colleagues were working on the missile which is carried primarily by the appatch khaoe attack helicopter -- apache attack helicopter there was a problem in bad weather. a missile of this propulsion system gives off smoke plume cannot be directed if the smoke hinders the guidance system. the engineering team on which joe worked developed a smokeless propellant which enhanced the missile's accuracy. joe and his team earned the
scientific and engineering award for 1980. when the helfar entered service in 19 # 4 it was intended for use against soviet tanks in a future cold war conflict. with the collapse in europe a few years later some began to doubt whether it was worth the course. however, with a laser guidance developed, the hell fire proved its worth during operation desert storm in 1991. in that conflict the army and marine corpses used it to disable the iraqi air defenses. apache helicopters launched missiles against targets demonstrating the usefulness of this new weapon. this guided missile system perfected in alabama by joe and other federal employees helped spare civilian lives in iraq and ensured a rapid coalition victory. they continued to play a role today as predator drones
carrying missiles on missions over afghanistan. madam president, our military depends on countless civilian engineers just like joe. without their hard work and important contributions, we cannot retain -- maintain the military strength we have today. they are all, every one of them, government workers and they work on bases and research facilities throughout the country, including the red stone arsenal in huntsville. these men and women wake up each day and go to work knowing that they directly participate in keeping america safe. the technologies they develop are made at the forefront of our fight against al qaeda and other extremist groups. we must never forget that they along with the rest of our civilian government employees enable the military to do its job. some give their lives for our country. others give their lives to it. all of them demonstrate this greatest hallmark of patriotism, which is sacrifice. joe could have made more money
in the private sector. he could have moved to work for a private contractor. but he didn't. his priority was making a contribution, not making money. in some ways we have lost sight of this sense of purpose, which is the engine of our american spirit. i am greatly encouraged that president obama has called for a new generation to take up the torch of public service through careers in government. he has called on us once again to make sacrifices in order to ensure the future safety and prosperity of this country we all love so dearly. our federal employees like joe feel a sense of duty to serve this great nation. it is what sustained him, a 20-year-old airman from alabama over italy, france, yugoslavia, china and japan. it is what sustained him as an engineer when he returned home to alabama and worked to build
america's defenses. it is love of country. it is service above self-. joe embodies this spirit, and i know he passed it on to the next generation. i can see it firsthand because his son, jeff, is my chief of staff, a great federal employee and a great person. families across america will gather this sunday to mark father's day and to celebrate the important bond between fathers and children. on this occasion i'm reminded of my own father who spent most of his career as a government employee and the important lessons he taught me about the value of public service. i also think about fathers throughout america who have chosen along with so many mothers to dedicate their careers to serving the public. they are powerful role models not only for their own daughters and sons, but for all young americans who want a chance to shape this country's future. i hope all my colleagues will join me in honoring the sacrifices and achievements of all our federal employees. i want to wish joe a happy father's day and the extend the