Combination Product Review Process ‘Unsettling’: Attorney
Attorney Jennifer Newberger (Hyman, Phelps & McNamara) says that a new pre-RFD (Request for Determination) process announced by the FDA Office of Combination Products (OCP) to provide a more interactive approach to product designation should be “unsettling” to any sponsor who has dealt with OCP. Writing in her firm’s FDA Law Blog, Newberger says there is a problem in that the pre-RFD process does not ask sponsors to provide a recommendation for classification and assignment of their product with a corresponding rationale.
“The idea of providing information about a product without also having the opportunity to provide a recommendation as to product jurisdiction and relevant precedent should be unsettling,” she writes. “Even when provided with a jurisdictional recommendation and information about precedent, OCP is likely to assign the product to CDER. Without the sponsor advocating for its position, the odds of a CDER jurisdictional determination is nearly a foregone conclusion in any submission where the product might arguably be a drug.”
Newberger writes that OCP has earned a reputation for designating products as drugs rather than devices, and it is well aware of industry’s frustration with the unwritten presumption that products should be regulated as drugs. OCP has acknowledged that the information to be provided as part of the pre-RFD process is similar to that of a formal RFD — a complete, clear, and detailed product description, which includes the product’s indication for use, its composition/ingredients, and an explanation of how it works.
In addition to not having to submit a classification recommendation, sponsors also will not have to discuss the classification of currently marketed products that they believe to be similar to their product. They can receive preliminary feedback and information from FDA that is derived from a structured and efficient process, OCP has said. It says that the feedback will ultimately help lead to better decision-making and development of products for the sponsor.
“The only possible advantage to engaging in a pre-RFD or informal RFD before submitting a formal RFD is that it will give the company insight into what OCP is thinking and the basis for which it believes the product is a drug,” Newberger concludes. “This information could prove useful to the sponsor when developing its formal RFD submission, as it would allow the company to address the issues raised by OCP in the earlier process. The downside, of course, is that it takes 60 days to reach an informal or pre-RFD decision, and the decision reached is not binding…. The problem with OCP is not the RFD process per se. It is the outcome of that process, particularly the inherent bias that most combination products can and should be regulated as drugs. Until that bias is fixed, no process, formal or informal, will alter industry’s frustrations with OCP.”