An FDA insider offers insights into FDA’s promising moves in managing combination and digital product submissions.
Karen Corallo believes there are a lot of positive moves going on at the FDA – and she should know. Corallo, of counsel at global law firm Greenberg Traurig, is the former director of the FDA’s Division of Drug Imports, Exports, Recalls, & Shortages at the Center for Drug Evaluation & Research. Before that, Corallo was associate chief counsel in FDA’s chief counsel office. Today, she represents pharmaceutical and medical device industry clients in administrative, regulatory and enforcement matters.
Corallo spoke with MDO on the energy coming out of FDA, noting the effects of the 21st Century Cures Act as well as new commissioner Dr. Scott Gottleib’s industry-friendly tone. She discussed how FDA’s new pilot program on digital health products and improved transparency with combination product decisions are a step in the right direction.
MDO: You went from private practice to the FDA, where you spent the last six years before returning to private practice. What did you observe and how can medtech take an active role it the regulatory process?
KC: After spending 27 years in private practice working on the side of industry, I had a unique perspective going to the FDA and putting on the regulator’s hat. During my time at the agency, I found there is more that unites than divides. Although industry and regulators have different motivations and interests, there is sufficient overlap: Innovators want to see good, safe devices get to patients as quickly as possible, and so does the FDA.
“Partnering with industry” was a phrase I heard often at the FDA from the highest levels of leadership. That has real meaning for sponsors during product development and review, where industry can engage their reviewers by educating them on the technology in a collaborative way. It builds trust and commitment on both sides and helps to ensure a smooth review process. Most importantly, it goes a long way in avoiding late-cycle surprises. Demonstrate your expertise in your product design and performance and bring the reviewers along so they thoroughly understand the technology, and there are no surprises on either side. And communicate as often as necessary so there is a shared understanding about the technology and the issues.
MDO: What trends are you seeing for combination products? Has the FDA been able to respond to criticisms about lack of transparency and deadlines for decisions?
KC: I saw one statistic that the market for combination products is expected to reach $144 billion this year. That number provides context for the attention combination products received in the 21st Century Cures Act. The device provisions of the Cures Act provide more clarity and transparency around the process of assigning the product to a lead center and streamlining the review, clearance or approval of combination products. It fits nicely into commissioner Gottlieb’s larger focus on facilitating development of innovative and effective therapies as key to lowering healthcare costs over the long run, including clarifying R&D requirements to limit unnecessary regulatory costs. The review of combination products also drives the agency toward finding better ways to collaborate between and among product centers and with stakeholders.
Another point worth mentioning given to us by the Cures Act is the “clarity and certainty” meeting. After a product has been assigned to a center, you can request this meeting to address approval/clearance standards, good manufacturing practices, post market changes, among other things. Most importantly, as a result of this meeting, FDA and the sponsor will agree on these elements and incorporate them into a plan, known as the Combination Product Review Plan. Anyone who’s been through the review process knows how valuable this tool is to mitigate regulatory risk. It keeps something like a change of personnel from derailing things.
MDO: FDA has issued guidance related to mobile medical devices and digital health. What are your thoughts on the pre-certification program?
KC: Guidances – one of my favorite subjects. They are pure gold when trying to understand the agency’s thinking on a given topic. The number of guidances from FDA in the last six to 18 months on the topic of digital health speaks to the importance of the topic. I predict that the FDA will continue to segment the market and allocate its limited resources on products that pose the greatest risk to patients and away from the lowest-risk devices. The pilot pre-certification program is a great example of a new approach to regulatory oversight for digital health technology. This program aims to pre-certify software developers with a track record in developing, testing, and maintaining software products – and work in a culture that honors quality and organizational excellence. The FDA’s assessment will be based on objective criteria. It shifts the regulatory focus from the product to the software developer because the FDA’s traditional approach, used to monitor hardware-based devices, doesn’t work for the faster, iterative approach to software products. To borrow a phrase, this is a giant leap for the FDA and a welcome one.
MDO: What trends generally do you see at the FDA that could be helpful to medical device companies?
KC: At the risk of repeating myself, the FDA will continue its hands-off approach to lower-risk digital health technology, like we’ve already seen with medical device data systems, general wellness products and clinical decision support software. Because the FDA can’t be expert in everything as quickly as technology is evolving, I think you’ll see more collaboration between regulators and sponsors and, I hope, a true partnership. I saw it personally during my time with the agency and have been heartened by what I’ve heard commissioner Gottlieb talk about. We’re in this together to get good, safe, high quality and effective products to patients as quickly as possible. This is a shared goal that should drive behavior on both sides of the regulatory fence, and I think we’re seeing that now.