New RFD Process: FDA’s Tacit Acknowledgment of Flaws in the System
[Posted on: Thursday, August 18, 2016]
It is critical that a product be properly classified as a drug or medical device. For products where a clear unambiguous scientifically justifiable classification as a drug or medical device cannot be made, the developer are required to make a Request for Designation (RFD) with the Office of Combination Products (OCP) at the FDA. Classification of a given product as a drug or device could have a dramatic impact on its regulatory pathway to market approval. Clinical and non-clinical studies, regulatory applications, design of the trials, available regulatory incentives, statutory review time-lines; even FDA review fees are extremely different for a drug or a medical device product. Whether a product should be regulated as a drug or a medical device depends on its primary mode of action (PMOA). For products where the PMOA can arguably be both similar to that of drugs or medical devices, sponsors are required to seek FDA’s formal assessment of product classification via the RFD application. OCP designates a product as a drug or a medical device, via a complicated determination process, involving review divisions at CDER and CDRH, and lawyers. And almost every time, there are disagreements with the sponsors regarding OCP’s decision regarding the product classification decision. The OCP has built a reputation that it mostly designates products as drugs, and once it does, there is no changing of the decision despite protests by the developers. There have been rare occasions when the OCP revised its original product classification. Hence the RFD is one of the most dreaded processes of the FDA by the industry since it could seal the fate of a product. FDA’s product classification is different and extremely conservative compared to practically all other regulatory agencies. There are numerous cases where a given product was classified as a medical device by practically all regulatory agencies, except FDA. OCP has argued that its process is based on current science and is related to the most significant safety and effectiveness questions presented by the product. However, developers frequently disagree and blame the OCP for a non-transparent process. To address this complaint, OCP announced that it would allow the applicants to submit a pre-RFD request so that OCP can give its comments without making a final decision giving the applicant a chance to revise their formal RFD application to address the comments made. The applicant for pre-RFD will not need to suggest the potential product classification or provide examples of similar products to aid the OCP in its designation. By doing this the OCP tacitly acknowledges that its current process for application review and dispute resolution is inadequate. More importantly, it gives an applicant a chance to simply not file a formal RFD if they know the potential outcome. While OCP’s intent is certainly good, this new process does not change much. There is no change in the overall policy regarding the review process, or gives the applicant any special benefit. Also, it is not clear how this process will be better than having a pre-submission meeting with OCP. Rather it adds additional 60 days to the final decision since the applicant will still be required to file a formal request and get an official designation. It would have been more beneficial if the OCP had clarified its policies, and provided a defined process for disputing classification decisions. This may look like help, but it seems like more work, with no change in the outcome.