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Compliance In Focus
Posted by Jacqui Lingler on Mon, Apr 22, 2013

5 BIG Challenges Concerning Combination Products

5 BIG Challenges Concerning Combination ProductsThe area of combination products is an exciting expanse of potential innovation and discovery for both the medical device and drug industries. However, there are many unique aspects that must be considered when dealing with combination products.

Recently an article posted on MD+DI which speaks to the balance the FDA’s Office of Combination Products (OCP) has of dealing with the medical device industry and the pharmaceutical world. Some of the challenges that may present in the area of combination products include understanding the classification, and jurisdiction of these products. Overall, device-drug products may have oversight from different departments depending on their make-up. OCP acts as an “umbrella” and one of its responsibilities is assigning combination products to agency centers. These agency centers include:

  • CDRH – Center for Devices and Radiological Health
  • CDER – Center for Drug Evaluation and Research
  • CBER – Center for Biologics Evaluation and Research

As stated by the OCP Associate Director of Policy, John B. Weiner, “OCPs primary mode of action is assignment. What part of the combination product is doing the most work?” Assignment to these agency centers is dependent upon the primary mode of action of the combination product. As of 2005, the primary mode of action is defined as “the single mode of action of a combination product that provides the most important therapeutic action of the combination product.”

In addition, other challenges Weiner points out (as stated in the MD+DI article) include:

  1. Legal – there are currently no statutory or regulatory standards for combination products.
  2. Marketing – the drug, biological product, and device industries differ in their markets.
  3. Premarket – drugs and devices have different data requirements, review timelines, and other premarket factors such as promotion and advertising (i.e. what can be said or claimed about a device versus a drug). In this regard Weiner says, “I would err on the side of caution as far as not pushing past the most restrictive requirement.”
  4. Post-market – challenges included clarity of duties and reconciling regulatory requirements.
  5. Cross-labeling – these challenges, which can be unique to combination products, include labeling consistency, proprietary data reliance, coordination of changes, coordination of marketing review, and authorization.

Check out our other recent blog post on OCP which speaks to some of the looming concerns facing OCP by those in the medical device and pharmaceutical industries.

Do you think the process of OCP assignment is consistent and efficient? Or, do you think a special agency center needs to be formed to deal with combination products? Share your thoughts with us!

Photo Credit: KaCey97007

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Topics: Office of Combination Products, Combination Products, MD+DI

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