Sign up for the QMED & MD+DI Daily newsletter.
FDA to Improve Combination Product Review Process
An FDA review, based on interviews with FDA staff and stakeholders, finds room for improvement in the combination product review process.
Marie Thibault
October 16, 2015
3 Min Read
Marie Thibault
FDA has turned a critical eye on itself, examining its regulation of combination products—those that merge drugs, devices, and/or biologics—to find ways to make the premarket review process better.
FDA's combination product review process requires different agency centers to work together. The review process for such a product is led by the center that regulates the part of the product that is responsible for the primary mode of action (PMOA). For instance, with a drug-eluting stent, the device part is viewed as contributing the PMOA, so CDRH is the lead review center. FDA's Office of Combination Products (OCP) provides oversight and guidance for the combination product review process.
Observers have been critical of this process. This year, senators proposed legislation to streamline the combination product review process. Last year, the Combination Products Coalition sent a report to FDA detailing "the problems innovators are now facing during the FDA review process," gathered from industry feedback through surveys and interviews.
In an introduction to its own review, FDA's Office of Planning writes that "Because combination products are products composed of two or more separate products and regulated under different types of regulatory authorities, and by different FDA Centers, intercenter consulting raises challenging regulatory, policy, and review management issues. These challenges have been exacerbated as the number of intercenter consults has increased." A chart included in the report shows that the number of intercenter consults has shot up from about 100 in FY2003 to over 800 in FY2013.
The FDA report goes on to admit that "Individual companies as well as industry groups have expressed concerns regarding the consistency and clarity of FDA's communications related to combination product review."
Room for Improvement
After conducting its own evaluation through focus group discussions with CDER and CDRH staff and interviews with FDA stakeholders and staff, FDA's Office of Planning has summarized the main issues, below:
"Different Policies, Practices, and Application Types: . . . Differences in application review standards—particularly between 510(k) submissions and approval applications—and in data requirements and expectations among Centers create complexities that make it difficult to achieve consistency in the outcome of a combination product review and present challenges to timely response."
"Separate Review and Tracking Systems Between Centers: Being unable to access other Centers' data systems in a timely manner and lack of a shared technical platform were seen as a significant source of delays and inefficiencies in the consult process."
"Unclear Communication Channels Between Centers: There is a lack of clarity regarding cross-center communication channels, resulting in problems where staff are not sure where to direct consult requests or how to appropriately follow-up on prior requests."
"Lack of Resources to Review Consults: Lead Centers do not reimburse time spent by staff of other Centers on intercenter consult requests, presenting workload challenges for the consulting Center."
Changes in the Works
In its report, the Office of Planning details its recommendations to tackle these problems. Robert Califf, MD, FDA's deputy commissioner for Medical Products and Tobacco, and Jill Hartzler Warner, JD, FDA's associate commissioner for Special Medical Programs, write in an October 15 FDA Voice blog post that improvements are on the way. They write that FDA already has or will be:
"Issuing more guidance for reivew of combination products (e.g., our pending draft guidance document on human factors);
"Enhancing and simplifying data access and sharing for internal staff;
"Making it easier for staff to request and monitor inter-center consults;
"Updating and maintaining our internal contact directory for experts to review a combination product; and
"Improving our internal standard operating procedures for premarket reviews and compliance activities."
"It may sound a bit mundane, but doing this work could help us work more efficiently and avoid unnecessary surprises for sponsors," Califf and Warner wrote.
Want to catch up on the latest in medical device innovation? Register for the MD&M Minneapolis conference, November 4–5, 2015. |
Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie.
[Image courtesy of ANANKKML/FREEDIGITALPHOTOS.NET]
About the Author(s)
You May Also Like
