November 3, 2015
The FDA and Intercenter Consultations
Just a few short weeks ago, Robert Califf, the US Food and Drug Administration (FDA) Commissioner nominee, endorsed an internal report. This report provided recommendations on how the FDA could improve reviews of combination products.
Combination products include:
- Products comprised of two or more regulated components, such as drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity – like a pre-filled syringe;
- Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products – think of items that are “kitted” together;
- A drug, device, or biological product packaged separately that is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use – think of items that are packaged separately, but intended to be used together.
Why Combination Products Are Increasingly Complex
As medical science has advanced, products submitted for FDA review are utilizing increasingly complex formulations, including unique and creative combinations of drugs, biologics, and devices. Because of this complexity, combination products, by definition, may require intercenter consultations with the FDA.
FDA’s Procedures for Intercenter Consultations
In 2002, the FDA created a set of procedures for these consults. The procedures are for FDA staff to follow when requesting, receiving, handling, processing, and tracking formal reviews of combination products.
Regulatory Challenges with Combination Products
This creates complex regulatory challenges for both the FDA and the developer of the product. The regulatory challenge with combination products is that there are many different combinations of products. This means that no single set of manufacturing rules will apply to all of them. The FDA’s draft guidance aims to clarify how to apply the agency’s rules to various situations.
Industry Concerns About FDA Intercenter Consultations
After an industry study revealed concerns over communication and coordination issues during intercenter consultations. The FDA began investigating ways to improve management, timing, and timeliness, as well as address workload challenges. The study team made five recommendations for improvement:
- Establish clear guidelines for the review of common combination product types.
- Create new simplified processes for access to CDER’s Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) and CDRH’s Image 2000 for consulting reviewers.”
- Update the Intercenter Consultative/Collaborative Review Process Standard Operating Procedures and Policies (SOPP) Manual and Intercenter Consult Request form and make them easily accessible on the OCP website.
- Create and maintain a combination product-specific organizational chart and contact directory, ensuring personnel changes are kept current.
- Establish a mechanism for estimating time spent on intercenter consults so resources can be allocated appropriately to organizational units to assure adequate review performance.
Califf claims that efforts “consistent with report recommendations” have been made to the first four recommendations and says more improvements “will be coming this year and next.“ For those of us in the regulatory compliance arena, we’ll have to keep a close eye on this to note any changes or improvements.
Russ King is President of Methodsense, a consulting firm that helps clients deliver medical and technological breakthroughs by effectively meeting the requirements needed to bring their products to market.
