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Legislation to stop brand companies from using authorized generics to undercut the 180-day marketing exclusivity awarded to the first successful patent challenger is garnering bipartisan support, as a House version of a recent Senate bill has been cosponsored by members of both parties.
Legislation to stop brand companies from using authorized generics to undercut the 180-day marketing exclusivity awarded to the first successful patent challenger is garnering bipartisan support, as a House version of last week’s Senate bill has been cosponsored by members of both parties.
ClinicalTrials.gov will be expanded to include a results database in addition to the existing trial registry if a bill introduced in the Senate passes.
While the generic drug industry expressed support for recommendations in the Bush administration’s proposed fiscal 2008 budget that would speed up the approval process by collecting fees from manufacturers, the White House should focus on resolving key obstacles that impede bringing generic drugs to market, industry sources say.
The Bush administration is not providing sufficient funding or making the argument for the FDA’s effort to improve drug development, known as the Critical Path Initiative, observers say.
Weeks after congressional leaders convened on Capitol Hill to discuss a bill aimed at stopping anticompetitive agreements between generic and brand drug firms, more legislation has emerged targeting another much-criticized practice — launching authorized generics.
A congressional inquiry called to determine the adequacy of the FDA’s approval process for generic drugs might be a sign of strong support among lawmakers for legislation proposed last month that would create a clear pathway for follow-on biologics, according to industry sources.
President Bush’s proposed 2007 budget includes funding to increase certain functions of HHS, but some lawmakers criticized cuts to Medicare and Medicaid.