Gottlieb Announces Policies to Address REMS Exploitation by Brand Drugmakers

The FDA called out brand drugmakers for using REMS to delay and block competitive generic drugs, announcing two draft guidances designed to help generic drug makers get their products to market and preserve the safety controls intended by REMS.

In a statement accompanying the release, Gottlieb said the new policies address impediments at the back end of the generic drug development process when a generic is seeking approval and market entry.

The current law requires that brand and generic companies use a single, shared system REMS, unless the agency waives the requirement and permits the generic drug to use a separate, comparable REMS program.