As reported in Seriously, What is Going On at the Office of Combination Products?, some in the medical device community have criticized the Office of Combination Products (OCP) at FDA. In particular, those critics have accused OCP, ironically, both of being weak because the office lacks independent authority and for overstepping its bounds. How is that even possible?
But it is that criticism which is out of bounds. Since its inception, OCP has served as an important resource to combination product manufacturers of all shapes and sizes.
OCP consistently helps manufacturers navigate the murky and sometimes stormy waters created by the cross-center regulation of their products. I frequently hear stories from companies in the combination product space about how OCP interceded when a dispute arose either between centers, or between the centers and the sponsor. The office has acted like an ombudsman on steroids, specifically focused on the unique issues associated with combination products. Indeed, they get some of the highest marks of any office at FDA when it comes to responding quickly to pleas for help.
OCP also drives the development of combination product guidance and ensures issues central to combination products are incorporated into center-specific and cross-center guidance documents. OCP’s value has not diminished and is not likely to anytime soon. This is particularly true as combination products are becoming more ubiquitous and the twenty-plus year old inter-center agreements need refreshing.
Representing industry, the Combination Products Coalition
(CPC) has worked closely with OCP almost since its inception. While we may not agree on all matters and occasionally wish OCP could do more and faster, the office is an extremely valuable resource. For example, OCP recently finalized the combination product Good Manufacturing Practices
regulations and is actively working with the various centers to develop implementation guidance to add specificity underneath the regulations. As part of the development of this guidance, OCP served as a valuable facilitator, bringing industry representatives and FDA together soon after the final rule was published to discuss topics that the guidance should address.
As combination products become more prevalent and their regulation continues to evolve, the CPC looks forward to continuing to work with OCP to address such areas as:
- Clarifying the roles and responsibilities of OCP vis-a-vis the various centers.
- Updating the inter-center agreements.
- Developing guidance on human factors and usability testing for combination products.
- Tackling the unique issues associated with conducting clinical trials on combination products.
- Enhancing transparency through the publication of Request for Designation letters.
There will always be people unhappy with any system. As a coalition that includes medical device, drug, and biological product manufacturers large and small, we spend an enormous amount of time discussing policy proposals to ensure that they are the best for the patients we all serve. Certainly there are many manufacturers of drug-device combination products that would prefer to be regulated as devices. But that isn’t always possible or appropriate.
At a coalition, we don’t always see eye to eye with OCP, but we are very glad to have them managing the combination product issues within the agency. For those of us who are getting on in years, we remember what life was like before OCP, and the old days clearly were not good for combination products. We are lucky to have those days behind us and OCP going forward.
Brad Thompson is a Member of the Firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. He also heads up the firm's Connected Health Initiative, and blogs for mobihealthnews.com.