Sebastian Jones catches some under-the-radar shenanigans from two house Democrats and a Republican on behalf of Big Pharma:
At a North Carolina town hall yesterday, the President went out of his way to mention a brewing legislative battle on Capitol Hill: the fight over how long to grant drug manufacturers monopolies on a new class of drugs called biologics and when to allow cheaper, generic alternatives.
The current proposed legislation–HR 1427 introduced by Representatives Waxman (D-CA) and Deal (R-GA)— would grant biologics the same 5-year period of exclusivity traditional pharmaceuticals receive now and would limit a manufacturer’s ability to get an extension of that monopoly, requiring, for example, a “significant therapeutic advance.”
However, Representatives Eshoo (D-CA), Inslee (D-WA) and Barton (R-TX) are planning to introduce an amendment which tows the brand-name industry line that a 12-year monopoly is needed and waters down the criteria for a given biologic’s period of exclusivity to be extended. The practice of getting extensions for small tweaks to the original product–things like shifting the delivery method from a pill to an injection or changing the dosage from twice a day to once a day–has been labeled “evergreening” by consumer groups. This month, the European Union’s antitrust regulator said she would begin to monitor the practice closely.
In a copy of the amendment obtained by The Nation, the conditions under which a drug’s exclusivity may be renewed are numerous and strikingly vague:
“A change…that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength; or a modification to the structure of the biological product that does not result in a change in safety, purity, or potency.”
This essentially grants big drug manufacturers the ability to wait until the 11th hour to make slight adjustments and receive a substantial extension.
These prolonged monopolies, preventing the production of generics and keeping drug prices high in a healthcare system fraught with increasing costs, might explain why the President has expressed concern about the issue.
Full text of the Eshoo, Inslee and Barton Amendment is below. Also, for more information on the biologics issue, check out this recent editorial from the Post.