Congresswoman Eshoo responds to Jane Hamsher

[ProSense]

Rep. Anna Eshoo Congresswoman (D-CA)

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."

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[Cha]

1. Why does Hamsher do

this? Aren't the facts enough for her? I personally wrote her an email back in August because she was disingenuously misrepresenting the President's stance on the PO.

[noiretextatique]

2. Consumer groups battle Eshoo's health care amendment

Consumer groups are still hoping to persuade Congress during this month's health care reform negotiations to make it easier to create generic versions of drugs known as biologics.

Biologic drugs are created through biological, as opposed to chemical, processes — researchers use plant and animal cells to grow new molecules. They are far more complex than most chemically produced drugs and much harder to duplicate. The top-selling biologics include cancer drugs such as Avastin and several drugs used to treat rheumatoid arthritis and anemia.

Rep. Anna Eshoo, D-Palo Alto, authored an amendment, which was added to the House version of the health care reform bill in July, that would grant biotech firms a 12-year period of market exclusivity on biologics, more than twice the 5-year period that other drugs receive. A similar measure is in the works in the Senate.

Critics charge Eshoo with selling out the public on behalf of the biotech industry, a powerful special interest on the Peninsula and a major contributor to Eshoo's campaigns. Eshoo claims she's trying to balance the interests of consumers and biotech companies, which spend billions developing these drugs.

Sarah Rimmington, an attorney for consumer group Essential Action, called Eshoo's amendment an "unjustified price gouge of the American public." She said 12 years of market exclusivity is far too long and called into question the pharmaceutical industry's claim that biologics are far more expensive to produce than other kinds of drugs.

Rimmington also blasted a clause in the amendment that critics claim would allow biotech companies to restart their 12-year window every time they make minor adjustments to their drugs — combining two types of drugs, for instance, or providing them in different doses — a process known as "evergreening.".

Consumer groups were recently joined in the biologics fight by student groups, including the American Medical Student Association and Universities Allied for Essential Medicines. In a statement issued by the student groups on Monday, Yale University medical student Sara Crager said that, as a future biomedical researcher, "I want the fruits of my research to be available as widely as possible as soon as possible."

http://www.essentialaction.org/access/index.php?/categories/1-NewsIn-the-News

[quiet.american]

3. From reading Eshoo's rebuttal, it seems the "12 yrs" timeframe is being misinterpreted.

Hamsher: "...thanks to Representatives Anna Eshoo and Joe Barton, there will be no generic versions of these drugs. At least not for 12 years..."

Eshoo: 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.)

Hamsher: "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."

Eshoo: 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.

[Phoebe Loosinhouse]

4. Not misinterpreted ----spun

Eshoo is focuses on that fact that most EXISTING drugs will currently be available as generics sometime hopefully soon.

But what about NEW drugs that are not yet FDA approved? Eshoo doesn't address that - unavailable for 12 years and if they do make a structural modification, longer.

[slipslidingaway]

7. Quote from this article - half of the new drugs approved in 2015 will be biologics...

you are correct, the argument is about the future. Today Herceptin may be the drug of choice, 5 or 10 years from now it could be something else.

http://www.time.com/time/politics/article/0,8599,1931595-1,00.html

"...While only 20% of drugs on the market today are biologics, it is expected that, with 633 biotechnology medicines in development last year for more than 100 diseases, half the new drugs approved in 2015 will be..."

[quiet.american]

8. The thing is, Eshoo did address accelerating the process for new biologic drugs.

I'll admit, this is a new conversation to me -- however, Eshoo's rebuttal really makes Hamsher's criticism seem ill-informed. If Eshoo didn't have a leg to stand on, I would be the first one to call B.S., however, in her response, Eshoo does address the development of new biologic drugs and has authored an amendment to accerlerate the process:

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."

On the 12-yr limit, according to Eshoo, her bill, for the first time, places a 12-yr limit in an area in which no limits were ever placed, and it is a limit in line with a standard currently in place.

Wasn't one of Hamsher's complaints that there wouldn't be access for 12 yrs to a certain drug? However, according to Eshoo, this drug's patent will actually expire next year, therefore granting access much sooner than 12 yrs. And that goes for the most popular drugs that patients need access to, as well. I don't see how that's a bad thing, and quite honestly, it really looks like Hamsher got her facts badly wrong on this.

[ensho]

5. kick

nt

[slipslidingaway]

6. It is the data exclusivity portion of this that has come under fire...

the bio companies and venture capital companies want 12 years.

They won!

The FTC report recommended zero years for data exclusivity, this is seperate from their patent protections.

Waxman recommended 5 years, same as other drugs...Obama suggested a compromise a 7 years.


How Drug-Industry Lobbyists Got Their Way on Health Care

http://www.time.com/time/politics/article/0,8599,1931595-2,00.html

"...While only 20% of drugs on the market today are biologics, it is expected that, with 633 biotechnology medicines in development last year for more than 100 diseases, half the new drugs approved in 2015 will be....

The Federal Trade Commission (FTC), though, argued in June that giving biologics makers any period of exclusivity at all could actually stifle innovation. Biologics are so much more complex and expensive to produce than traditional drugs that the barriers to would-be "biosimilar" competitors are already high, the FTC said. Giving biologics further protection — particularly the 12 years of exclusivity that the industry wants — would merely encourage firms to tinker with what they have rather than drive them toward "new inventions to address unmet medical needs."

Most small biologics companies are still years away from seeing their first profits in this high-risk, high-return business. Their trade association, BIO, says that in the past 11 months, at least 40 of them have cut back or eliminated drug-development programs. The venture capitalists who invest in them "aren't looking to cure Parkinson's disease as much as they are looking for a return on their investments," says Greenwood. "They're just as happy to put their money into the next iPod." But increasingly, the big players in the pharmaceutical industry are moving into the biologics business themselves, either by investing in cutting-edge firms or by acquiring them.

...Shifting Politics

That makes the politics — and the lines of political influence — a lot more difficult to sort out. Whereas the traditional pharmaceutical industry is concentrated in just a couple of states, biotech firms have sprung up just about anywhere you find a university with a research hospital, which gives them a broad political base. "I know that vote hurt me at home," says Ohio Senator Sherrod Brown, who led the unsuccessful fight against the 12-year exclusivity in the Senate HELP Committee.

Indeed, the biologics lobby has become one of K Street's most powerful players. Working largely through BIO and the Pharmaceutical Research and Manufacturers of America (PhRMA), it has funded an extensive network that includes not only lobbyists but also think-tank experts and advocacy groups. "You can't get on the phone with someone who isn't getting paid," says an economist who has studied the biologics issue with funding from a drug company. "They give money to everyone and anyone."


...Among the biologics industry's most high-profile advocates has been former Democratic National Committee chairman Howard Dean, who is consulting for a law firm that has a deep roster of biologics clients. In July he wrote an Op-Ed in the Hill newspaper arguing for a "commonsense and fair approach" to give biologics companies at least 12 years of exclusivity. ("I wouldn't do this if I didn't believe it," Dean, a physician, said in an interview.) His former campaign manager Joe Trippi echoed Dean's views on a Huffington Post blog without disclosing that he had been paid by BIO to create two Web campaigns. (He also says his views predated his paycheck.)....."

[slipslidingaway]

9. Post by Jane Hamsher...

http://fdlaction.firedoglake.com/2009/10/31/amsa-med-students-visit-anna-eshoos-office/

"...Eshoo wigged out yesterday in the Hill and the Huffington Post and launches a bitter, personal attack in response to my article on her PhRMA-friendly legislation — and Nancy Pelosi’s daugher helps her promote it. Which is surprising — I said I was “disappointed” in Pelosi because I thought she was just bowing to the will of the caucus, but I guess she’s endorsing Eshoo’s efforts. (I know Christine, she’s very cognizant of how this stuff reads and doesn’t do things like this in a vacuum).

I’ll have a more detailed rebuttal later, but in the mean time, I invite you to read the Pelosi-endorsed Eshoo melt-down and watch the video of these wonderful young students and compare.

As medical student Sha Ali says, the government is already paying money for the research and development of these biologics, so to make the health care system absorb enormous costs for drugs the public already has an interest in is deeply corrupt — and the cost in human life is completely immoral.

Eshoo’s demand for “data exclusivity” (patent monopoly) to protect “innovation” (blockbuster pharmaceutical profits) is wound around such a shameless pack of lies it’s amazing that it only cost drug companies $712,983 in campaign contributions. As the students say, this is a $71 billion boondoggle for PhRMA. They are paying Eshoo pennies on the dollar for the privilege of raking in enormous profits on government-sponsored research..."

[slipslidingaway]

10. Obama administration had recommended a compromise of 7 years...

http://blog.pharmtech.com/2009/06/26/the-seven-year-itch-in-biologics-patent-exclusivity/

"In the debate over establishing a regulatory pathway for biologics, the White House recommended this week to limit data exclusivity for biologics to seven years, according to a Reuters report. Reuters reported that the Office of Management and Budget Director Peter Orszag and Nancy-Ann DeParle, director of the White House Health Reform Office, sent a letter to Representative Henry Waxman (D-CA), chair of the House Energy and Commerce Committee, whose committee is considering biosimilar legislation, stating that seven years “strikes the appropriate balance between innovation and competition.” As would be expected, supporters of limiting exclusivity such as the Generic Pharmaceutical Association (GPhA) applauded the proposal while the Biotechnology Industry Organization (BIO) raised concerns...


As discussed in PharmTech’s blog, the debate on data exclusivity for biologics was intensified with the release of a Federal Trade Commission (FTC) report earlier this month that said that the 12–14 years of regulatory exclusivity for biologics was too long to promote innovation particularly since innovator-drug firms would likely retain substantial market share after the entry of a follow-on biologic (FOB), according to an FTC press release.

GPhA agreed. “In citing the recent FTC report on biogenerics, the President rejects attempts by the pharmaceutical and biotech industries to needlessly extend market exclusivity provisions to an unprecedented period of 12 to 14 years simply to maintain their monopolies on biopharmaceutical products,” said GPhA President and CEO Kathleen Jaeger, in prepared statement. “The White House and Office of Management and Budget correctly recognize that this exclusivity model will not achieve what should be our shared goal of balancing pharmaceutical innovation and much needed consumer access.”

However, BIO, which represents innovator biotechnology drug companies, said curtailing exclusivity was ill-advised..."