Copyright The White House
31.10.09
Stars come out for breast cancer prevention fundraiser
The second lady held court at a breast cancer fundraiser Friday that drew some of Delaware's most powerful men to the BBC Tavern and Grill in Greenville.
Jill Biden and her husband, Vice President Joe Biden, were at the newly opened restaurant to raise money for the Biden Breast Health Initiative. The nonprofit, founded by Jill Biden in 1993, aims to educate teenage girls about the value of early detection of breast cancer.
About 250 people packed the restaurant, including U.S. Senators Ted Kaufman and Tom Carper.
Attorney General Beau Biden and Congressman Mike Castle, who are expected to compete in the 2010 Senate race for Kaufman's seat, also were on hand. Castle has already announced his intent to run for Senate.
As the pink ribbon is the international symbol of breast cancer awareness -- and since October is National Breast Cancer Awareness Month -- many of the attendants wore pink ribbons on their suits and dresses. Jill Biden wore a black cocktail dress with a pink pashmina shawl. The vice president wore a dark suit and a red tie.
The event was expected to raise up to $6,000, money that would go to the initiative's Julianne E. Hammond Scholarship Fund. The fund provides financial assistance to young adults who are pursuing careers in health or education. Last year, more than 2,600 high school girls learned about breast cancer self-examinations through the initiative.
(Adapted from Delaware Online)
The Washington Destination for Halloween... The White House
Add this to the list of duties for President Barack Obama and his wife, Michelle: having enough candy to satisfy 2,000 trick-or-treaters banging on the White House door.
The White House said Friday the Obamas will give a Halloween welcome to hundreds of children from schools in Washington and the surrounding Maryland and Virginia suburbs. The trick-or-treaters will come to the front door on Saturday just as they would at any other house – except it will be the soaring North Portico of the White House.
Later, the president and first lady, as well as Vice President Joe Biden and his wife, Jill, are hosting a Halloween reception for military families and the children of White House and residence staff.
This Week on the Hill...
MONDAY 26TH: Senate Majority Leader Harry Reid discusses healthcare reform.
TUESDAY 27TH: President Obama speaks at a ceremony to honor former Senator Edward Brooke with the Congressional Gold Medal in the Capitol Rotunda.
TUESDAY 27TH: Chair of the Environment and Public Works Committee Senator Barbara Boxer, Senator Arlen Specter and Energy Secretary Steven Chu gather for a hearing on the 'Clean Energy Jobs and American Power Act.'
TUESDAY 27TH: Senator John Kerry provides the opening statement at the Senate Environment and Public Works Committee.
WEDNESDAY 28TH: Senator J Rockefeller and Senator Kay Bailey Hutchinson discuss legislation to curb the behaviour of drivers distracted by cell phone usage at the Senate Commerce, Science and Transportation Committee.
THURSDAY 29TH: Speaker Nancy Pelosi celebrates the healthcare reform bill following a press conference on the steps of the Capitol.
THURSDAY 29TH: House Majority Leader Steny Hoyer holds Speaker Pelosi's hand following her announcement.
FRIDAY 30TH: Senator Olympia Snowe reacts to a question about healthcare reform.
30.10.09
Rep Anna Eshoo: Setting the record straight on our Health Care Legislation
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."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." My amendment prohibits by its plain language exactly what Ms. Hamsher alleges it would encourage.
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."She's absolutely correct -- if we develop an AIDS vaccine, a cure for cancer or diabetes, or an effective treatment for Alzheimer's, ALS, Parkinson's or countless other of our most horrific diseases, it will come through biotechnology. Each of these research pathways is difficult and costly, and will require billions of dollars in investment. If we undercut the incentives for this research, who exactly will invest in these life-saving biologics? Will we see companies shifting their resources to developing the next great erectile disfunction drug or cure for baldness?
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.
White House Photos: October 2009
First Lady Michelle Obama and Dr Jill Biden react to a play whilst watching Game 1 of the World Series between the New York Yankees and the Philadelphia Phillies at Yankees Stadium, Bronx, NY, October 28th 2009. 
Associate Director of Press Advance Katie Hogan, right, listens as President Barack Obama delivers remarks during a Democratic National Committee fundraiser at the Hammerstein Ballroom in New York, N.Y., Oct. 20, 2009. (Official White House Photo by Pete Souza)
President Barack Obama hugs Sen. John Kerry (D-Mass.), who recently returned from Afghanistan, prior to their meeting in the Oval Office, Oct. 21, 2009. (Official White House Photo by Pete Souza)
The Washington Monument and Jefferson Memorial are seen at dusk behind the the South Lawn Fountain of the White House, Oct. 22, 2009. (Official White House Photo by Lawrence Jackson)
Visitors on the 2009 Fall Garden Tour pass by the Oval Office as President Barack Obama talks on the phone with Prime Minister Recep Tayyip Erdogan of Turkey, Oct. 17, 2009. (Official White House Photo by Pete Souza)
President Barack Obama and House Speaker Nancy Pelosi have lunch in the Oval Office Dining Room of the White House, Oct. 22, 2009. (Official White House Photo by Pete Souza)
Staff and interns gather on the South Lawn of the White House to watch President Barack Obama's Marine One departure en route to Andrews Air Force Base in Maryland, Oct. 21, 2009. (Official White House Photo by Samantha Appleton)
President Barack Obama talks with MacKenzie Clare, 14, and the other Girls Scouts after signing the Girl Scouts USA Centennial Commemorative Coin Act in the Oval Office, Oct. 29, 2009. First Lady Michelle Obama looks on at right. (Official White House Photo by Pete Souza)
Obama Tree Planting
Fall Harvest at the White House
Children from Bancroft Elementary School and Kimball Elementary School joined the First Lady yesterday as they revealed the fall harvest goods from the White House Garden. Many impressive items have been grown, including sweet potatoes and onions. As usual, Mrs O looked super stylish in purple- including her (and mine!) trademark purple Converse, Sacai belt and hope and peace style necklaces.
29.10.09
News from Congress
Speaker Pelosi and fellow members of Congress unveil the House Health Care Reform Bill:
Members of Congress played basketball in their traditional game against members of the Capitol Police last night. Congress won: 32-26.
Members of Congress played basketball in their traditional game against members of the Capitol Police last night. Congress won: 32-26.
President Obama honors the fallen
President Obama travelled to Dover Air Force Base in Denver last night, to honor the transfer of 18 US personnel killed in Afghanistan in the past week.
Mrs O and Dr B in New York
Mrs O and Dr B attended Game 1 of the World Series last night walking Yankees legend and Hall of Fame Yogi Berra onto the field at Yankee Stadium. They were also accompanied by Iraq veteran Tony Odierno, who threw out the ceremonial first pitch.
Earlier in the day, the pair attended James J. Peters VA Medical Center in the Bronx.
Subscribe to:
Posts (Atom)
