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布什在2008预算将提议非专利药审核费
(2007-01-02 11:49:21)
Tuesday, Jan. 2, 2007
BUSH TO PROPOSE GENERIC USER FEES IN 2008 BUDGET
The Bush administration will propose industry-supported fees in the 2008 budget to enhance the FDA's generic drug reviews, an agency source says.
The fees would be contingent on the FDA meeting certain review milestones, leading to a more predictable review process, the source said. These fees would provide the agency with more money to do drug reviews, potentially ensuring greater access to cheaper, generic drugs, the source added. The agency originally proposed the fees in October.
The generic drug industry is supporting the move, but cautions that the fees alone are not enough. While additional funds might speed up the generic review process, it will not help accelerate approval of the drugs, a Generic Pharmaceutical Association spokeswoman said. The federal government must also take steps to eliminate tactics that brand companies allegedly use to delay introduction of generics to the market.
The generic drug industry maintains that brand drug companies have used authorized generics, which is a brand company's drug repackaged and sold at a lower market price through a subsidiary or a third party, to undermine the generic drug market. Generic manufacturers also allege that the brand drug industry files frivolous citizen petitions to delay the onset of generic competition.
BUSH TO PROPOSE GENERIC USER FEES IN 2008 BUDGET
The Bush administration will propose industry-supported fees in the 2008 budget to enhance the FDA's generic drug reviews, an agency source says.
The fees would be contingent on the FDA meeting certain review milestones, leading to a more predictable review process, the source said. These fees would provide the agency with more money to do drug reviews, potentially ensuring greater access to cheaper, generic drugs, the source added. The agency originally proposed the fees in October.
The generic drug industry is supporting the move, but cautions that the fees alone are not enough. While additional funds might speed up the generic review process, it will not help accelerate approval of the drugs, a Generic Pharmaceutical Association spokeswoman said. The federal government must also take steps to eliminate tactics that brand companies allegedly use to delay introduction of generics to the market.
The generic drug industry maintains that brand drug companies have used authorized generics, which is a brand company's drug repackaged and sold at a lower market price through a subsidiary or a third party, to undermine the generic drug market. Generic manufacturers also allege that the brand drug industry files frivolous citizen petitions to delay the onset of generic competition.
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