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 within its existing authorities to encourage such collaboration, said Marc...

More from Generics

More from Biosimilars & Generics