Increased Generic Drug Transparency: Faster Access to Information
New rules aim to make it easier for generic drug companies to get key information from the government agency. This could speed up the process of bringing cheaper drug alternatives to market, potentially lowering healthcare costs for citizens.
Key points
Generic drug companies can now ask the government agency if their product is qualitatively and quantitatively the same as the original drug.
The agency must disclose if the generic drug's composition differs from the original, specifying ingredients and deviations.
Once a determination of sameness is made, the agency cannot change it unless the original drug was withdrawn for safety/effectiveness or an error is found.
The agency will issue guidelines on how it determines drug sameness, increasing predictability for manufacturers.
Introduced
Citizen Poll