In her response to my article on her biologics bill, Anna Eshoo vehemently claims it doesn’t allow “evergreening,” which would allow slight tweaks in drug formulas to grant drug companies endless monopolies and keep these lifesaving drugs from ever becoming 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.
That’s news to Henry Waxman. Here he is on July 31, 2009 at the Energy and Commerce markup, on Anna Eshoo’s biosimilar amendment to H.R.3200:
I know that members of this committee support creation of a biosimilar pathway. I know they believe it will bring competition and reduce the high price of biologics. I endorse that, but I strongly believe that adoption of this amendment exactly the wrong way to achieve increased competition and lower prices nor will it enhance innovation.
This amendment enacts a lengthy monopoly period — twelve years — and then allows those periods to be extended indefinitely, the so-called “evergreening problem.”
The evidence is overwhelming that these open-ended monopolies will create huge obstacles to competition. To those who want competition in the biologics market, I refer people to a letter from the CEOs of the 28 major generic drug companies. They say, monopolies with this long an unpredictable period of time — that they will not even enter the biosimilar market because there is no economic incentive for them to do it.
To those who want lower cost, look to what the payers are saying and the patients group, a coalition of consumer groups AARP, unions, businesses and state and private payers strongly oppose this amendment because it will rob us of the opportunity to achieve significant cost savings for patients and payers. To those who think this is going to bring innovation look at the report from the federal trade commission which conducted a year-long investigation and concluded that monopolies this long would severely damage both competition and innovation, creating real competition in the drug marketplace is one of the best opportunities we have to control costs.
But by passing this amendment, we’re not only missing a historic opportunity to bend the cost curve. We’re guaranteeing higher drug costs for the foreseeable future.
I understand a large majority of this committee supports this amendment. I do not.
And I will continue to make my case that we need real competition to bring down the costs of our nation’s drug bill not endless monopolies for the drug industry as members continue to look at this issue. I think they will come to understand that this amendment is not the right way to go.
The experts agree with Waxman. Glad to see Eshoo is committed to opposing evergreening, however. She better get to changing her language before her amendment passes the House.





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Great work, Jane. Is anything being done to bring this to the attention of her constituents?
although anecdotal, I am still struck by how Eshoo went back on her word to Chairman Waxman for a voice vote and rammed a roll call vote through – I may be new to the sausage making, but I know it is rarely done and it speaks volumes to me as to who is zoomin’ who here
Thanks, Jane.
Good morning CBL
mornin’ Scooter Boy
Yep, I got that video coming too.
This is really a detailed and great answer to Eshoo too.
http://fdlaction.firedoglake.com/2009/11/02/uaem-and-amsa-respond-to-rep-eshoo-point-by-point/
fyi –
Pelosi to send Bill to Floor Today
update from TPM:
So will Eshoo admit that the lobbyists basically wrote her amendment?
Or will she admit that she didn’t know what she was doing?
What is really depressing is that I come to this site everyday just to find out how the morons in Congress are “f”ing up health care reform. I sign all the petitions, write the letters call the Critters try to do my part to make reform REFORM, but I just get more sad each day.
What is an easily understood example of a “structural modification”? Would adding caffeine to aspirin be one? Or adding salt, or sugar?
AND THE KILLIN’ GOEZ ON AND ON AND…
Citizen Hamsher and the Firepup Freedom Fighters:
What the fuck is goin’ on in the Democratic caucus in the House of Representatives??!! Why can’t the Chairpersons of the committees control their folks on bills as important as these…shit, with members like these the Democrats don’t need an obstructionist, irrelevant Republican Party!! Awe fer Christ’s sake…mumblemunblemumble…
And what the hell is goin on in the Senate with Obama’s appointment to head the OLC…Dawn Johnson is her name isn’t it?
KEEP THE FAITH AND PASS THE AMMUNITION, AND DON’T WORRY ABOUT AIMIN’ ‘CUZ THE BASTARDS ARE EVERYWHERE!!
Hmmm, Waxman or Eshoo. Whom to believe?
Certainly not the major Pharma recipient.
Sorry, Ms Eshoo, time to change your amendment.
If you really oppose evergreening, that is.
You do, don’t you?
Also please see slinkerwink’s point-by-point rebuttal of Anna Eshoo’s Huffington Post piece, at Daily Kos here.
there were scattered reports last week that Specter (one of the original obstructionists) had ‘changed his mind’ on Dawn Johnsen – will try to find link
So, the language hasn’t changed from then till now. It would be helpful to see the versions side by side.
that she partnered with a reactionary corporatist like Barton and that every Repub on the committee voted Aye should also provide a rather large clue
Evidently Dems think they need 100 seats in the Senate to approve any of Obama’s nominees and even then it wouldn’t be a sure bet.
Here ya go
In Anna’s own words in the Huff Post piece, it seems that there’s a hole big enough to drive a truck through for the pharma industry. Just a minor tweak and the 12 year rule no longer applies. I’m going to call her office this morning and see what I can find out.
There are two issues here. First, it is common for a drug manufacturer to come out with a medication that needs, say, to be taken 3 times a day. When it comes time for the patent to run out, the manufacturer may come out with a new formulation that only needs to be taken once a day. Another trick drug manufacturers have is to change the indication. Some anti-convulsants (for epilepsy) end up being used for chronic pain, mood stabilizers, or migraine. An anti-depressant (SSRI) can be used to treat obsessive-compulsive disorder (OCD). This is what Eshoo seems to be talking about that would not be allowed.
But drug companies can also change the chemical structure of a medication. They can add a methyl (CH3-) or a hydroxyl (-OH) group and voilà, a new patent covered medication. Make the dosing easier as I described above and put the weight of your advertising department behind it and you have the kind of evergreening which Eshoo’s statement in fact allows.
I was sitting here wondering why, oh, why do people lie so much? Especially when a person is in a position of service to their constituents and, through the miracle of modern technology, it is easy to prove that they are lieing.
Then I read Hugh’s comment, and it hit me! I mean, do they ALL have OCD?
How else to explain it? I’m not being snarky here either.
Looks like Pelosi is getting the corporate giveaway the hell out of dodge… before the local yokels can show up with enough torches and pitchforks to take the corporate goodies away.
does OCD stand for Only Cash Delivers ???
mornin’ gal :D
This is just really hard for me to take in.
Are they really saying, “Hey, we’ll change this component a teeny bit and presto, you all have to pay $48,000 a year for the medicine for the next 12 years AGAIN!”
Sen. Sherrod Brown (D-Ohio) makes a very good point:
And a Really Good Morning to you. The reason I was not being snarky is this. You and I know how a personality
disorder can affect a person’s life. If a person had OCD, for example, they might choose a career path that put them in a position where they are In Control. Do you know what I’m saying? There is a particular type of personality that goes for political leadership roles, isn’t there?Just wondering stuff. That, and house cleaning. Ha.
Thank you for being your sweet, smart self, cbl.
Hugh, thank you, that’s exactly what I was looking for.
Quick note of thanks to Jane Hamsher.
Thank you for creating this place. Thank you for your tenacious attitude and courage and strength to stay on track. Thank you for bringing together like-minded and like-hearted folks to share and work together. Really. Thanks.
Eshoo clearly wants to have it both ways, to say out of one side of her mouth:
And, out of the other side, to endlessly justify granting manufacturers of biotechnology products a permanent monopoly:
And, of course:
So “some period of ‘data exclusivity’” becomes a never-ending period, right?
I also really liked how she tied herself to Speaker Pelosi and especially to Senator Kennedy, as if an attack on her is an attack on them, too. Bs.
If I misunderstood something in Eshoo’s argument, please help me understand her better.
That diary makes it clear that Eshoo either is ill informed about “structural modifications” or is just blowing smoke when she claims she prohibits evergreening.
She says she wants to prohibit evergreening. I’m writing to her staffer to ask her to substitute Waxman/Schumer’s much clearer language. I’d also like to see the 5 year period, unfortunately she hasn’t indicated any agreement that she would support a shorter exclusivity period.
I can’t believe how dishonest Eshoo is being on this. The “anti-evergreening” clause she is referring to is not an anti-evergreening clause at all. Look for yourself on page 1538 of the bill. The text she quotes specifies an expedited pathyway by which the original manufacturer can amend their exclusivity application for “a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength.” That is the exact opposite of what she said.
The Kennedy thing rankles me. She’s not defending her legislation, she’s using the Kennedy name to say it must be good.
It also raises some questions, because HELP had Schumer’s biosimilars language as well as Eshoo Barton. They went with the Eshoo language.
How did that come about? Both the committee and Senator Kennedy’s staff could see Schumer’s language was better for containing costs.
Thank you. And thank you for showing up to support the students at the demonstration, too. They really appreciated it.
You have to start reading on the previous page (1537, line 24 “Shall not apply”) prohibits longer exclusivity for non-structural changes to dosing, means of administration, etc. The diary makes it pretty clear that this can be gamed by doing minor structural changes.
Eshoo made a defensible statement – minor changes to things like dosing don’t restart the exclusivity clock.
Eshoo blew smoke, minor structural changes do restart the exclusivity clock.
No worries. Who’d have thought that earnest young medical students and DFHs are natural allies :-)
I’m not seeing it in the final language, but in the original Eshoo biosimilars bill a “New indication” could restart exclusivity for that new indication. Since a biosimilar for the original indication could be manufactured and marketed for the original indication it’s moot; off label prescription of the generic for the new indication could happen.
Knox, I wasn’t ignoring your question. I was speaking to Eshoo’s office. My comment re that is in the next thread.
depressing yes but we have to keep keepin on. I sometimes think this epic battle is merely basic training for the eventual and oh so necessary fight on Campaign Finance Reform
when I become disheartened, (oh about every other day or so) I remember our quadriplegic brothers and sisters with breathing tubes, protesting and willing to be arrested outside Big Insurance offices – then I go back to the phone or bang out another Letter to the Editor
stay with us and fight, we’re all we’ve got :D
There were three of her constituent present at her office on Friday along with the medical students. One of the med students was from Stanford, so that makes four total.
In threads over the weekend a few more of us have showed up. San Jose Mercury News was given a press release; nothing in Saturday’s paper, I’ve not had a chance to read Sunday’s because I was cooking for a bunch of bikers. Nothing recent shows up in a search of the Murky Snooze’s website
I haven’t seen the bill’s language. I am only running off of Eshoo’s statement in the post.
I spent most of Halloween trying to inform myself on this; Eshoo’s attack on Jane bothered me.
On a technical level Eshoo is correct that her legislation prohibits exclusivity for changes to dosing, etc. The diary linked at “experts agree” in the post, makes it clear that in practice it does allow evergreening via structural changes.
Thanks. I’m off in a moment to see it.
Hi wmd1961!
I agree. As you put it perfectly: “[Eshoo’s] not defending her legislation, she’s using the Kennedy name to say it must be good.”
I honestly don’t know as much about the legislation yet as you do, but her arguments at HuffPost were lame efforts at best to defend her positions, whether some have merit or not.