FDA Pilots Intercenter Process For Combination Product Reviews

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA) has started the pilot phase of its new intercenter consult request (ICCR) process, designed to streamline submissions and reviews of combination products. The agency expects full implementation to finish by the end of 2017’s second quarter.

Sponsors of combination products (any combination of a drug/device/biologic) have claimed that they encounter delays during reviews due to having to deal separately with the Center for Devices and Radiological Health (CDRH) or the Center for Drug Evaluation and Research (CDER), with the Centers’ incongruent policies and slow coordination. FDA sought the input of focus groups and industry, who looked into how the agency could improve its intercenter consults.

FDA Commissioner Dr. Robert Califf later endorsed the recommendations to improve the overall efficiency, consistency, and predictability of combination product reviews.

The recommendations came pending FDA's final rule on postmarket safety reporting for combination products, first proposed in 2009 and anticipated since May, but yet to be released, according to RAPS.

However, in April, FDA announced creation of the Combination Products Policy Council, which will have decisional authority on issues relating to combination products. The agency also carried out lean mapping of the combination product review process.

As an update on these substantive efforts, Michael Rappel, Ph.D., Senior Science Advisor in FDA's CDER and member of the Lean Management Team, and Rachel E. Sherman, M.D., M.P.H., FDA’s Associate Deputy Commissioner for Medical Products and Tobacco, wrote in a blog post that the agency will now pilot the proposed intercenter consult request (ICCR) process in select offices within its three medical product centers.

They identified the following "important improvements" to be applied to the combination products cross-center review process.

• Establishing timelines, specific to center and submission type, for identifying products as combination products and issuing and completing consults needed to support the review;
• Developing a tiered consult approach that streamlines interactions across centers and identifies a clear process for identifying the right experts for a consult;
• Defining clear roles and responsibilities for the Lead Center, the Consulted Center(s), the Office of Combination Products (OCP), and the Combination Product Council for review of a combination product submission; and,
• Creating a standard, semi-automated, user-friendly ICCR form that is managed electronically to ensure 1) users always have the most updated version, and 2) all forms, and thus all intercenter combination product consults, are tracked through a single system.

Phase 1 will last for two months, and subsequent phases of the full implementation is targeted to finish in the second quarter of 2017.

"During each phase of implementation, we will collect quantitative and qualitative data to evaluate success. What we learn at each stage will allow us to refine processes, procedures, and training for subsequent phases," wrote the two officials. "In particular, data from phases 1 and 2 will be used largely to refine the initial steps of the ICCR process (e.g., consult request, ICCR form, reviewer assignment) though some limited consult completion data (e.g., consult quality and timeliness) available for Investigational Device Exemptions/Investigational New Drugs may provide initial insights on consult closeout," states the FDA Voice blog post.

Rappel and Sherman added that this new intercenter process for combination products will serve as a flagship model for other cross-agency initiatives at FDA.