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.