In a letter dated Wednesday, US Food and Drug Administration (FDA) Commissioner nominee Robert Califf endorsed an internal report detailing recommendations for how FDA could improve reviews of combination products, but says that the agency is already in the midst of addressing the issues called out in the report.

Background

Combination products, or any products combining drugs, devices, and biologicals, create complex regulatory challenges for both FDA and their sponsors.

In 2002, in order to better coordinate the review of combination products, FDA created a set of procedures for intercenter consults. These consults are intended to improve the "timeliness and consistency" of FDA staff "when requesting, receiving, handling, processing, and tracking formal consultative and collaborative reviews."

Intercenter Consult Process Study

In 2014, after an industry survey highlighted concerns over communication and coordination issues during Intercenter consults for combination products, FDA's Office of Planning (OPL) launched a study into coordination and communication at the agency.

Specifically, the study aimed to look into "management, timing, timeliness, and workload challenges" related to intercenter consults.

To conduct the study, FDA staff asked two industry groups, the Combination Products Coalition (CPC) and the Advanced Medical Technology Association (AdvaMed), for input on the issues industry faces from intercenter consults.

After receiving input from industry, the study team held a series of focus groups with staff from two of its centers, the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER). Afterward, the study team conducted 18 interviews with FDA staff ranging from those in "leadership positions [and] in key roles related to combination product review."

After reviewing the data gathered during the discussions and interviews, the study team identified four issues:

1. Different policies, practices and application types
2. Separate review and tracking systems between centers
3. Unclear communication channels between centers
4. Lack of resources to review consults

Recommendations

After considering the major issues brought up during the discussions with industry and FDA stakeholders, the study team issued five recommendations for the agency to undertake to "improve the overall efficiency, consistency, and predictability" of combination product reviews:

1. "Establish clear guidance for the review of common combination product types."
2. "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."
3. "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."
4. "Create and maintain a combination-product-specific organizational chart and contact directory, keeping personnel changes current."
5. "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's Response

After thanking OPL for its assessment and recommendations and stating his office's commitment to "effective, efficient, transparent, and consistent regulation," Califf asserts that the agency is already making strides towards many of the recommendations.

In the letter, Califf claims that the Centers, the Office of Special Medical Programs and Office of Combination Products have already made efforts "consistent with report recommendations" to the first four recommendations and says that more improvements "will be coming this year and next."

Intercenter Consult Process Study (With Letter), FDA Voice, Combination Products Coalition Recommendations