I attended an action “Treats, not tricks” at Anna Eshoo’s Palo Alto office. Her staff distributed a packet that called out Jane Hamsher by name; it is posted at Huffington Post. Representative Eshoo responds to at least one of the comments at uffPo… I’ve not done a detailed look at the comment threads, but I am heartened to see Eshoo engaging with her critics there.

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.

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.)

etc, etc.

She clearly is feeling some heat from Jane’s writing.

“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.

I’ve asked Anna’s Senior Field Representative to give me a citation for the title and section of the legislative language that accomplishes this prohibition. If it does in fact prohibit evergreening then that’s a good thing and Anna deserves some credit. If this is just an assertion made for PR purposes that’s another matter. My hope is that Jane is wrong on this and that Anna did the right thing here. If that’s the case Jane will certainly correct herself and give props where they are due.

The packet contained a San Jose Mercury News editorial from June 24, 2009 (abstract only at link, full article on pay site).

The packet also contained laudatory letters about her amendment from:
The Association of American Universities (July 20, 2009 – 1 page)
The ALS Association (Lou Gehrig’s disease) (July 16, 2009 – 1 page)
Alliance for Aging Research (July 16, 2009 – 1 page)
American Autoimmune (July 16,2009 – 1 page)
Retiresafe (July 16, 2009 – 1 page)
California Institure for Regenerative Medicine (July 6, 2009 – 3 pages)

I too was glad to see Eshoo respond – still digesting what she says

funny how it went from Eshoo-Barton to Kennedy-Eshoo though aint it ?

the good Congresswoman better pray Jane issues a correction – if not, I fully expect not only a factual refutation from Jane, but a um, fuller examination of the Congresswoman’s record to date – and from what I’ve seen that wont be pretty.