The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.
Bills introduced in Oregon's state legislature would allow employers and other health plan sponsors to have greater knowledge about how pharmacy benefit managers determine the rates at which they pay pharmacies for dispensing generic drugs; establish new standards for pharmacy audits while requiring PBMs to register in the state and be licensed by the state board of pharmacy; and prevent health plans from requiring residents of the state to use mail-order pharmacies.
While the Food and Drug Administration released draft guidance on regulations for biosimilars in February 2012, the final regulations have yet to appear. But already, everyone from analysts to trade groups to drug makers is preparing for a time when knock-off versions of biotech drugs will become available.
Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.
Global warming could spell the end of flu seasons, research released by the National Institution of Health suggests, because the influenza virus better propagates and is more sustainable in colder climates.
The stakes are high in a case involving generic drug maker Actavis and the Federal Trade Commission that will soon go before the Supreme Court, the head of a generic drug industry lobbying group said in a conference call with reporters Tuesday.
Several senators have requested that the Government Accountability Office look for ways to coordinate the efforts of law enforcement and public health agencies at various levels and nonprofit organizations to address prescription drug abuse.