Like millions of Americans, I was thrilled by today's unveiling by Speaker Pelosi of the House health care reform bill, the Affordable Health Care for America Act. I was proud to stand with the Speaker and my Democratic colleagues in support of this historic legislation. Since coming to Congress more than 16 years ago, nothing has been more important to me than achieving comprehensive health care reform and as a member of one of the primary committees responsible for drafting the bill, few members worked harder than I did in bringing it to the House Floor.
Ms. Jane Hamsher related some heartbreaking stories on HuffPost about breast cancer survivors and their struggles to overcome this devastating disease. I've heard dozens of similar stories and each one has moved me to do everything I possibly could throughout my public service to help breast cancer victims, and I have been a leader in the House of Representatives in promoting women's breast health. The National Breast Cancer Coalition, a group representing hundreds of organizations and millions of women who dedicate their lives to curing breast cancer has honored me with their prestigious 'Perfect Voting Record' honor. I've fought tirelessly to make it a federal crime for insurance companies to kick women out of their hospital beds right after they've had a mastectomy (the Breast Cancer Patient Protection Act). I fought for increased access to breast cancer screening so millions of women can catch the cancer before its too late (MRI and Mammogram Availability Act).
In 1997, I successfully authored and saw into law the Reconstructive Breast Surgery Benefits Act, which banned the practice of private insurers treating breast reconstructive surgery following a mastectomy as cosmetic surgery. In 2000, I was a leading sponsor of the Breast Cancer and Cervical Treatment Act, which allows states to use Medicaid dollars to provide health treatment coverage for low-income women diagnosed with breast or cervical cancer. I also serve as Chair of the Cancer Care Working Group, a coalition of members in the House who are dedicated to improving the care and treatment of cancer patients.
I'm exceedingly proud to have legislation I authored many years ago which prohibits lifetime health insurance caps included in the House health care reform bill. This cap affects many breast cancer victims, such as the woman mentioned in Jane Hamsher's HuffPost column, "House Health Care Bill: A Death Sentence for My Fellow Breast Cancer Survivors," effectively cutting off their insurance when they need it most. My legislation outlaws this practice.
Having put so much into these critical issues, I'm quite frankly outraged by the falsehoods and misrepresentations in Ms. Hamsher's column.
My amendment to create a new pathway for approval of 'follow-on' versions of innovative biotechnology products, or 'biosimilars,' will not deny patients access to these miraculous treatments. In fact, my legislation, sponsored by the late Senator Edward Kennedy, will create for the first time in our country's history an FDA approval process for biosimilars to compete with innovative biologics.
Today, no expedited pathway for approval of a follow-on version of a biologic product exists. There are only generic versions of traditional, small-molecule drugs. For biologics, any prospective competitor to a brand-name product would have to go through the same lengthy and expensive approval process and clinical trials as the original manufacturer. As a result, there is very little economic incentive to develop a competitive version of a successful biologic.
Under the legislation that Senator Kennedy and I championed, prospective biosimilar manufacturers would be permitted to use an accelerated approval process and utilize the clinical trials and laboratory data of the innovative product to demonstrate the safety and efficacy of their product. Biotechnology products are highly complex and, unlike traditional chemical drugs, they cannot be precisely duplicated by a second manufacturer. Our amendment would allow these follow-on manufacturers to say, in essence, "my product is close enough to the original product, and the FDA can rely on the innovator's safety and efficacy data to approve my product."
Biotechnology products cost billions of dollars to develop, test and bring to market, and in order to ensure that competitors aren't immediately allowed to free-ride on the costly safety and efficacy data produced by innovators, some period of 'data exclusivity' is necessary to allow some period of time to recoup the investment in developing the drug. Without such a 'data exclusivity' period, there would be no reason to invest in new biologics. We would see the flow of research funds going to traditional pharmaceuticals, medical devices, semiconductors, green technology or other more promising innovations.
The House and Senate health care bills include a data exclusivity period of 12 years, which is the same amount of time that all drugs enjoy on the market under patent protection, which prevents any competition. I believe the 12-year data exclusivity period preserves the existing incentives for investment in these life-saving products.
It's important to note that today there is absolutely no restriction on data exclusivity -- it's effectively infinite. Competitors are never permitted to use the data produced by a brand-name biologic manufacturer. The Kennedy-Eshoo legislation brings this exclusivity down from forever to 12 years, in essence laying the groundwork for the creation of the biosimilar industry, new competition for the biotechnology industry, and reduced prices for patients.
Let me individually address the patently false statements in Ms. Hamsher's post.
"...thanks to Representatives Anna Eshoo and Joe Barton, there will be no generic versions of these drugs. At least not for 12 years..."
The 12-year data exclusivity period in the Kennedy-Eshoo legislation begins from the time of FDA approval. Since the vast majority of the most popular biologics treatments were approved at least 12 years ago, this means that they would have virtually no data exclusivity protection. The important cancer and anemia treatments that millions of patients rely on will be subject to biosimilar competition as quickly as the FDA can process the follow-on manufacturers' applications. (For example, under my amendment Herceptin's data exclusivity period will expire in September 2010.)
"And because of an 'evergreening' clause that grants drug companies a continued monopoly if they make slight changes to the drug (like creating a once-a-day dose where the original product was three times per day), they will never become generics."
Finally, Ms. Hamsher seems to be describing an alternative outcome which is pure fiction. She rightly complains about the high cost of many biologic treatments which can run into the tens of thousands of dollars per year, but she seems to indicate that these products would be readily affordable for patients, if only we would subscribe to the proposals of generic drug manufacturers and the insurance companies.
The cornerstone of the Kennedy-Eshoo legislation is to bring down the costs of today's biologics by bringing them into an era of biosimilars, just as Congress moved pharmaceutical drugs to generic drugs.
The House health care reform legislation thankfully and finally allows the Secretary of the Department of Health and Human Services to directly negotiate the costs of drugs and biologics for Medicare recipients.
I want to highlight a point on which Ms. Hamsher and I are in complete agreement:
"If an AIDS vaccine is found, it too will be a biologic."
I'm proud that the legislation that Senator Kennedy and I have worked on for over three years is included in the healthcare reform bills inn both legislative bodies. I'm proud to have this legislation endorsed by: The AIDS Institute, ALS Association, Alliance for Aging Research, American Autoimmune Related Diseases Association, Association of American Universities, Candlelighters Childhood Cancer Foundation, former Vermont Governor Howard Dean, M.D., Immune Deficiency Foundation, the National Alliance on Mental Illness and many other patient advocacy groups.
Our amendment passed by large bipartisan majorities in the House Energy & Commerce Committee (47 to 11) and the Senate Health, Education, Labor and Pension Committee (16 to 7). It is supported by ten governors who have written to the bipartisan congressional leadership supporting the amendment.
Ms. Hamsher attributes nefarious motives to this effort and the legislation. I fiercely disagree. It was carefully shaped and guided by Senator Kennedy and myself with the highest purposes of bringing life-saving biologics to include biosimilars, to save lives and to bring down the costs to every human being in our country who needs them.
In Congress, I will work to support affordable prices on biologics, so that victims of cancer, HIV, diabetes, Parkinsons, rheumatoid arthritis, and multiple sclerosis can afford the medicine they need to stay alive.
Huff TV: Ryan Grim On Democrats Health Care Plans, Political 'Kamikaze'
Huffington Post Senior Congressional Correspondent Ryan Grim appeared on MSNBC Monday to talk about health care reform legislation and its prospects in the Senate and...
What we need is healthcare - not health insurance !!! Health "insurance" is a misnomer. There isn't a gamble as to whether you will get sick, it's a matter of when you get sick & what illness/accident you encounter. Once you do have an accident/illness, you find out whether your premiums have been forfeited.
They have handed thirty to forty million currently uninsured over to the insurance companies at some sort of negotiated premium subsidized by the taxpayer and protected the insurance compainie's base of 200 million currently insured against any premium reduction. The Democrats will tell us what a deal they have made for us. They threw in some bones like portability and pre-existing conditions.
There was never was even any intention of reforming healthcare. Even Obama is in on this make believe Public Option. Where is the outrage? If any one thinks that there is going to be serious reforms coming for the financial section regulation, the same game is in the works.
Oh, and thanks to my Democratic Party for refusing to repeal the Bush tax cuts and instead funding this thing by taxing my "Cadillac Health Plan", which is really just an HMO that my union gave up wage increases for and for which we workers pay part of the premium out-of-pocket already.
Oh, and good luck in the 2010 elections. No more door-knocking, phone calls, yardsigns, checks, get-out-the-vote at work, etc. I'm done. Obama can ask his new Republican friends to help him and the Party.
trade associations spent more than $110 million — that's about $609,000 a day — to influence lawmakers, according to figures compiled by the nonpartisan watchdog group Center for Responsive Politics. The drug industry's legion of registered lobbyists numbers 1,228, or 2.3 for every member of Congress.
And its campaign contributions to current members of Waxman's committee have totaled $2.6 million over the past three years
Congresswoman Eshoo - why the necessity for the roll call vote on the amendment - when your deal with Chairman Waxman was a simple voice vote ?? it's as if your Coporate Sponsors wanted a record of just who their friends were .
and what about these Med Students joining these actions with Ms Hamsher , Congresswoman - are they simply misinformed ???
end up in the domain of the FDA? No conspiracy just fact-it is all by design for
the biggest profit. The benefactor certainly is not the average woman.
Statements like this are proof positive, if proof was needed, of the fantasy world that members of Congress inhabit. If the bill is so wonderful and historic, why is she not telling the “millions of Americans” who apparently contacted her between the time she stood on the Capitol steps and wrote the article about how she plans to ditch her own healthcare package and sign up for what “we the people” are getting?
Rep Eshoo then goes on with the fervor of a pageant contestant and a flurry of “I”s to blow her own trumpet until the mouthpiece melts.
Is she really blind to reality or does she think we can’t see what’s going on? Or is she just indulging in a form of perverse gloating based on the fact that she knows she can’t be prevented from doing or saying whatever she likes?
i only ask that they put together the best possible program that will cover as many people as possible with a strong PO to fight cost.
i am still waiting for repcons to present a bill before congress to KILL FEDERAL FLOOD/HURRICANE INSURANCE plan, since that is an insurance plan the federal govt is involved in.
Thank you so very much for taking the time to clear away the fear that was going around about these issues. I posted posted article to NewsTrust in hopes it will help get the anti-fear message out.
Again, thanks!
You would find me and a very, very large number of conservatives support a bill if it included a provision to require competition across state lines even if we had to give in on requiring coverage and eliminating the pre-existing condition clauses. The problem with the far left leaders of the Dem party is that they will not support such a measure because they know doing so would create a market where prices would come down, people could afford insurance and there would never again be support for a single payer system which is what they want.
If you think that the market really will not meet the needs of the people, than it does absolutely no harm to add the requirement to break the state barrier on purchasing coverage. Denying this type of legislation does nothing more than show the disdain that the far left has for the free market and capitalism in general. If you like socialism and a canada/UK style of healthcare and tax rates go ahead and support any of the bills presented.
state barrier on purchasing coverage.
people keep making this point but they dont explain how it wont keep all the insurance companies from going after the same demographics they like and ignoring the ones they dont like. its called cherry picking. we would have one set of demographic having access to excellent rates and everybody else would be out in the cold.
if they were going to do away with state borders, then let them do away with all borders. i live 5 miles from the canadian border, i would love to buy into the canadian program if i could.
if it would truly make them competitive the insurance companies would be fighting tooth and nail to kill it. the repcons had the opportunity to pass this legislation years ago in their "contract on america" thingy, why didnt they do anything then? the PO will make them competitive, that is why they are working day and night to kill it.
I am dismayed that the welfare of the people is always secondary to turning a profit.
I am also dismayed by our politicians during the past 20 years who have exhibited more and more a concern for corporate profits, their own funding and less and less a concern for the people they are sworn to represent - the taxpayers.
I think I will absolutely work against ANY POLITICIAN WHO UTTERS THE WORD ENTITLEMENT AGAIN IN A DEROGATORY MANNER. Our tax monies were taken based upon a promise to fund a program. These tax monies were earmarked. Yet instead politicians like Lieberman, McCain and the rest think the monies are there for their cronies and their war games and act like the people expected a return on long ago promises is the equivalent of welfare. The only thing going on are politicans not here to serve the people and disrespecting those who paid taxes in good faith.
I do intend to now work against ANY AND EVERY POLTICIAN who does utter those words again in a derogatory manner. The welfare that has been going on is to pander to money ending up in politicians pockets and financing.
yes, we all knew that healthcare would be a full scale war. but get real, you cant fight two monsters at the same time. quit playing the innocent. obama is a disappointment in things like the public option, but splitting of the two big guys big pharma and insurance was one the most clever things he did. we are going to have to deal with big pharma after next years elections. we still havent won this war yet.
Anyone who wants to give them further time should rot in hell.
"The 12-year data exclusivity period in the Kennedy-Eshoo legislation begins from the time of FDA approval. Since the vast majority of the most popular biologics treatments were approved at least 12 years ago, this means that they would have virtually no data exclusivity protection. The important cancer and anemia treatments that millions of patients rely on will be subject to biosimilar competition as quickly as the FDA can process the follow-on manufacturers' applications. (For example, under my amendment Herceptin's data exclusivity period will expire in September 2010.)
and this:
"There is no 'evergreening' clause in my legislation. There is in fact an 'anti-evergreening' clause which explicitly provides no new exclusivity period would be granted for "a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength."
So it sounds like the bill's 12 year exclusivity clause on biologic drugs is the same as it is for other drugs we have now, plus the 12 year clock started 12 years ago for some of those drugs, so the exclusive clause will be moot for some drugs.
And the clause can't be renewed for some stupid reason like the dosage changed from 3x a day to once a day.
Single payer is not possible, but a medicare system with Medicare being the primary payer is.
Yes, taxes must pay for it... but wouldn't you rather pay for a war?