Exclusivity For Biologics, Drugs Should Be The Same After All, Grabowski Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Duke University economics professor Henry Grabowski and his colleagues suggest the Hatch-Waxman statute be revised to mirror biosimilars legislation and provide 12 years of market exclusivity.
You may also be interested in...
Too Much Success for Generics? GPhA’s Neas Defends Hatch-Waxman
Newly installed GPhA CEO Ralph Neas has a lot to juggle these days on Capitol Hill, between drug shortages and user free agreements for generics and biosimilars. But one thing Neas wasn’t expecting was a threat to Hatch-Waxman. Has the generic drug industry become too successful for its own good?
GPhA’s Neas Preaches Vigilance Against Reopening Hatch-Waxman Act
After five months on the job, Generic Pharmaceutical Association President and CEO Ralph Neas is optimistic about the industry’s future but prepared to do battle against any efforts to re-work the landmark 1984 law. Preparations include establishing a new non-profit arm, the Affordable Medicine Research Institute, which will focus on research and public education about generics and biosimilars.
Pediatric Study Delays Could Draw Civil Penalties Under Proposal For PREA, BPCA Reauthorization
Civil penalties would be more flexible than FDA’s current authority to label a drug misbranded if sponsors fail to conduct pediatric studies, Commissioner Hamburg argues as the House Energy and Commerce Committee’s Health Subcommittee opens hearings on reauthorizing prescription drug user fees.