Comments on: Waxman to Eshoo: You’ve Got An “Evergreening Problem”

By: Knoxville

Knoxville — Mon, 02 Nov 2009 20:04:46 +0000

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.

By: Knoxville

Knoxville — Mon, 02 Nov 2009 20:01:07 +0000

Thanks. I’m off in a moment to see it.

By: wmd1961

wmd1961 — Mon, 02 Nov 2009 19:09:39 +0000

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.

By: Hugh

Hugh — Mon, 02 Nov 2009 18:40:06 +0000

I haven’t seen the bill’s language. I am only running off of Eshoo’s statement in the post.

By: wmd1961

wmd1961 — Mon, 02 Nov 2009 18:37:11 +0000

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

By: cbl2

cbl2 — Mon, 02 Nov 2009 18:35:47 +0000

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

By: Twain

Twain — Mon, 02 Nov 2009 18:34:15 +0000

Knox, I wasn’t ignoring your question. I was speaking to Eshoo’s office. My comment re that is in the next thread.

By: wmd1961

wmd1961 — Mon, 02 Nov 2009 18:25:49 +0000

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.

By: wmd1961

wmd1961 — Mon, 02 Nov 2009 18:19:02 +0000

No worries. Who’d have thought that earnest young medical students and DFHs are natural allies :-)

By: wmd1961

wmd1961 — Mon, 02 Nov 2009 18:12:26 +0000

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.