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.
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