Posted: 16 Aug 2016 06:54 PM PDT
By Jennifer D. Newberger –
On August 11, 2016, the Office of Combination Products (OCP) announced a “pre-RFD” process. A Request for Designation (RFD) is the formal process for seeking FDA’s assessment of product classification, for example, determining whether a product should be regulated as a drug or a device. The key issue for designation is determining the primary mode of action (PMOA) of the product. If the PMOA cannot be determined, OCP is supposed to designate based on the Center that regulates other combination products that present similar questions of safety and effectiveness. If there are no such combination products, then OCP will assign jurisdiction to the Center with the most expertise related to the most significant safety and effectiveness questions presented by the product.
OCP has earned a reputation for designating products as drugs rather than devices, and OCP is well aware of industry’s frustration with the unwritten presumption that products should be regulated as drugs. OCP has supposedly been listening to industry, and trying to find ways to ease these frustrations. Earlier this year, FDA announced creation of the Combination Product Policy Council [http://blogs.fda.gov/
Now, OCP has announced the pre-RFD process, intended to provide a more “interactive approach” to product designation. OCP acknowledges that the information to be provided to OCP as part of the pre-RFD process is similar to that in a formal RFD—sponsors must provide “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.” OCP also states that both pre-RFD and RFD “require input from the product jurisdiction officers in the relevant Centers and, if necessary, legal perspectives from the Office of Chief Counsel.”
The following are the differences between the pre-RFD and RFD processes:
As for interactive feedback, we have heard this line before. OCP previously offered what it called an “informal RFD” process with the promise of interactive feedback and an opportunity to address questions as they arose during the course of OCP’s review. The reality, however, was quite different. The process still took 60 days and there was no interaction between OCP and the sponsor. The end result? An “informal” decision that the product was—you guessed it!—a drug.
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 why it believes the product is a drug. 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. If a company needs a formal designation, it must then submit a formal RFD and await a formal Letter of Designation—another 60 days. And if it wants to appeal to the Office of Special Medical Programs, there is no deadline for a decision, dragging out the process even longer.
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.
On August 11, 2016, the Office of Combination Products (OCP) announced a “pre-RFD” process. A Request for Designation (RFD) is the formal process for seeking FDA’s assessment of product classification, for example, determining whether a product should be regulated as a drug or a device. The key issue for designation is determining the primary mode of action (PMOA) of the product. If the PMOA cannot be determined, OCP is supposed to designate based on the Center that regulates other combination products that present similar questions of safety and effectiveness. If there are no such combination products, then OCP will assign jurisdiction to the Center with the most expertise related to the most significant safety and effectiveness questions presented by the product.
OCP has earned a reputation for designating products as drugs rather than devices, and OCP is well aware of industry’s frustration with the unwritten presumption that products should be regulated as drugs. OCP has supposedly been listening to industry, and trying to find ways to ease these frustrations. Earlier this year, FDA announced creation of the Combination Product Policy Council [http://blogs.fda.gov/
Now, OCP has announced the pre-RFD process, intended to provide a more “interactive approach” to product designation. OCP acknowledges that the information to be provided to OCP as part of the pre-RFD process is similar to that in a formal RFD—sponsors must provide “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.” OCP also states that both pre-RFD and RFD “require input from the product jurisdiction officers in the relevant Centers and, if necessary, legal perspectives from the Office of Chief Counsel.”
The following are the differences between the pre-RFD and RFD processes:
- Sponsors are not required to provide a recommendation for classification and assignment of their product along with a corresponding rationale (e.g., bench studies; clinical studies) for that recommendation;
- Sponsors are not required to discuss the classification of currently marketed products that they believe to be similar to their product; and,
- Sponsors can receive preliminary feedback and information from the Agency that is derived from a structured and efficient process. The feedback will ultimately help lead to better decision-making and development of products for the sponsors.
As for interactive feedback, we have heard this line before. OCP previously offered what it called an “informal RFD” process with the promise of interactive feedback and an opportunity to address questions as they arose during the course of OCP’s review. The reality, however, was quite different. The process still took 60 days and there was no interaction between OCP and the sponsor. The end result? An “informal” decision that the product was—you guessed it!—a drug.
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 why it believes the product is a drug. 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. If a company needs a formal designation, it must then submit a formal RFD and await a formal Letter of Designation—another 60 days. And if it wants to appeal to the Office of Special Medical Programs, there is no deadline for a decision, dragging out the process even longer.
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.
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