GPhA praises bill to block authorized generics
GPhA praised Representatives Jo Ann Emerson (R, Mo.), Zach Wamp (R, Tenn.), Marion Berry (D, Ark.), and Dennis Moore (D, Kan.) for introducing legislation to block the marketing of authorized generics during the 180-day exclusivity period awarded to the first generic to successfully challenge a frivolous or questionable brand patent. The bill (H.R. 806) is a companion to The Fair Prescription Drug Competition Act of 2007 (S. 438), introduced in the Senate on Jan. 30. "The 180-day exclusivity period has spurred competition, resulting in greater availability of safe and affordable medicines for consumers," said GPhA president/CEO Kathleen Jaeger.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
