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Federal investigators from the FDA’s Office of Criminal Investigations unexpectedly showed up Feb. 14 to conduct a full-scale search of Ranbaxy offices and a manufacturing plant in New Jersey, company sources said.
Members of the Senate Judiciary Committee unanimously approved Sen. Herb Kohl’s (D-Wis.) reverse-payment legislation — bringing the prohibition of that practice a step closer to becoming law.
The reintroduced “Access to Life-Saving Medicine Act,” a bill that would establish a clear and effective pathway for the FDA to approve generic copies of biologic drugs, may be attached to the Prescription Drug User Fee Act (PDUFA), congressional lawmakers said yesterday.
Motivated by lower co-payments for inexpensive alternatives to brand drugs, more Medicare Part D participants selected generic drugs to fill prescriptions covered by the drug benefit program last year than in 2005, according to new data from the Centers for Medicare & Medicaid Services (CMS).
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.
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.
Motivated by lower co-payments for inexpensive alternatives to brand drugs, more Medicare Part D participants selected generic drugs to fill prescriptions covered by the drug benefit program last year than in 2005, according to new data from the Centers for Medicare & Medicaid Services (CMS).
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.
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.