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Compliance In Focus
Posted by John Lehmann on Thu, Dec 10, 2015

Combination Product Pathway

During his November 17th conformation hearing at the Senate Health, Education, Labor and Pensions Committee FDA commissioner nominee Robert Califf indicated that the FDA could have a new combinationCombination_Product_Pathway pathway ready for approval within a year.  He is trying to replace Margaret Hamburg, who left the FDA back in April.

During the hearing Califf agreed that the FDA’s existing structure for reviewing combination products is not suitable.  “It’s a strong view at the FDA that we need another pathway that will give the FDA the flexibility to require the data that’s needed to ensure the public the proposed treatment is safe and effective.

Our blog back in 2012, describe exactly what a combination product is; however, the FDA has been struggling with the classification for many years.

The FDA’s problems reviewing combination products have been well documented.  Among the most common are a lack of user fee goals and deadline coordination between reviewing centers.  There are also inefficiencies with the inter-center consultations, a practice that has increased in recent years, in part due to a growing number of inquiries about human-factors issues surrounding drug-delivering devices. 

Also, many industry leaders feel the FDA leans too heavily toward designating a drug rather than device as primary mode of action for combination products.  This is being challenged in federal courts.

The timeframe outlined by the nominee suggests the FDA proposal would be ready by the end of 2016, possibly for inclusion into the user fee reauthorization legislation that Congress must pass in 2017.

Califf’s comments at the confirmation hearing on combination products are consistent with other comments he has made in other public forums.  Jeffrey Shuren, Center for Devices and Radiological Health Director has also supported the reform, potentially including the need for distinct review pathway and distinct user fee for combination products.

Do you agree that combination products need a new approval pathway?  Is the one-year timeline outlined realistic?  Share your thoughts with us.

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Topics: Combination Products, FDA, Robert Califf, Product Pathway


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