Combination Therapies: Incentives Needed To Encourage Labeling Across Products

If sponsors will not work together to ensure that labeling for all drugs used as part of a combination regimen are in sync, then US FDA should take measures to streamline process and Congress may need to step in with carrot or stick incentives, a multi-stakeholder group suggests.

Carrot sticks
Carrot sticks are the best carrot and stick approach.

Ensuring that drugs used together as part of a treatment regimen are similarly labeled for combination therapy may require a new regulatory framework in the US or even legislation to streamline the process and overcome hurdles to cross-labeling, stakeholders suggested at the recent Friends of Cancer Research (FOCR) annual meeting.

Cross-labeling of products owned by different sponsors is always easier if the companies work together, and FDA should take measures...

More from Generics

More from Biosimilars & Generics