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Obama's budget called for resolving that debate.
"The administration will accelerate access to make affordable generic biologic drugs available through the establishment of a workable regulatory, scientific and legal pathway," said the budget documents. The administration said it will work also to prevent biologic manufacturers from reformulating brand name drugs so that a slight change wins them additional years of patent protection.
Rep. Henry Waxman, D-Calif., long an advocate for generics, said he is "delighted" with the administration's endorsement.
"Legislation to permit FDA to approve generic biologics is one of my highest priorities this year," said Waxman, who chairs the House Energy and Commerce Committee. "I am in full agreement with the president that such a program will be self-defeating if it provides monopoly periods to brand name biotech drugs that are significantly greater than those currently provided to traditional drugs."
Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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