Both companies and the FDA continue to be frustrated with the mismatches between drug and device regulations along with the communication challenges between the product centers that lead to inefficiencies. FDA officials are signaling that the combination products review process is ready for reform and the 2017 user fee authorizations offer a good opportunity to make much needed changes.
“Those standards, those differences, create a lot of challenges for us, they create a lot of challenges for the drug and devices industries,” he said. “So maybe we’re at a point where we need to fix that, maybe we should be thinking about a third pathway, particularly when there’s a device primary mode of action.”
Robert Califf, FDA’s deputy commissioner for Medical Products and Tobacco, agrees about the need to reform the combination product program as part of the user fee process. He suggests improvements are needed in internal FDA communications and IT tracking systems for combination products along with more fundamental rethinking of how better to align standards for drugs and devices components.
According to Califf, one of the biggest challenges facing the FDA’s ability to regulate combination products include different review standards to 510(k)s, NDAs and PMAs. He also cautions against having two sets of data standards for drugs versus devices.
He feels that in the upcoming MDUFA negotiations, medical device companies need to get on board and realize that if we have common data standards, it will help drive the costs of clinical trials down.
There also needs to be a culture change at the FDA, as the agencies culture and structure need to be looked at. According to Thinh Nguyen, Office of Combination Products Director, data shows there has been a rapid rise in consultation requests by the lead review center to other FDA centers to assist in combination product reviews. This underscores the growing complexity of products and questions from the drug center about human-factors design issues for devices.
Also, many companies have questions about the overall effectiveness and efficiency of the consultation process.
According to Califf, there needs to be a change in culture at the FDA. “For sure, inside the FDA, it starts with acknowledging you have an issue which is hard to do when people are just trying to get their work done.”
Finally, even in advance of the user fee process, Congress is attempting to move forward with FDA reforms with the House 21st Century Cures initiative. Legislation that has recently passed through committee includes a mandate for FDA to write guidelines describing the responsibilities of each center that review combination products. However, Califf cautioned lawmakers to not to writ legislation that is too specific because it could prevent FDA from doing its job when considering the regulation of combination products is still an unsettled scientific area.
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