FDA says it is already simplifying access to its IT system, revising SOPs, updating its organizational charts and putting out more guidance documents, as recommended in an internal assessment of its inter-center consultation process for combination products that was released by the agency Oct. 14.

The assessment, conducted by the agency's Office of Planning, was launched in 2014 in response to complaints from industry that the product centers within FDA were not effectively coordinating and communicating, leading to confusion and delays in the review of combination products. In the meantime, the number of intercenter consultations has skyrocketed in recent years (see graph below), a significant portion of which are initiated as questions by drug center reviewers to the device center about device human factors issues. (See Also see "Human Factors Questions Drive Rise In FDA Inter-Center Consults" - Medtech Insight, 7 May, 2015..)

The internal study affirmed what many in industry and at the agency say they already knew: that "differences in communication, policies, practices, systems and application types can be challenging when the centers work together on a review of a combination product," Robert Califf, FDA's deputy commissioner for medical products and tobacco, and Jill Hartzler Warner, associate commissioner for special medical programs, noted in an Oct. 15 blog post summarizing the report.

Specifically, the report found that the different review timelines and application types between the centers – for example, the vast differences in expectations for a 510(k) clearance and drug approval – was one key source of complication in intercenter collaboration.

In addition, the assessment linked review delays to simple lack of cross-center access to different IT systems used to track reviews, unclear communication channels and a lack of targeted resources for 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," the report found.

To address the issues, the Office of Planning concluded that FDA should:

Issue specific guidance documents detailing data expectations for common combination product submissions;
Establish simplified processes for access to the device center's and drug center's separate review tracking systems;
Update its standard operating procedures for intercenter consultations;
Create and maintain a combination-product-specific organizational chart and contact directory; and
Establish a mechanism for estimating time spent on intercenter consults so resources can be allocated appropriately to organizational units to assure adequate review performance.

According to Califf, FDA is already directly addressing most of these points. In a response letter addressed to the agency's associate commissioner for planning, he pointed to ongoing efforts on a draft guidance on the role of human factors studies in the design and development of combination products, expected out later this year, as its first effort to provide more guidance.

He also confirmed that the agency is simplifying IT access across the agency and taking steps to make it easier for staff to request and monitor intercenter consults. And, further, FDA is updating its internal contact directory and SOPs.

The one recommendation Califf did not specifically address is the last one, to establish a mechanism for estimating time spent on intercenter consults as a means to improve resource allocation.

It is possible that issue might be addressed as part of the reauthorization of the device and drug user fee programs, which expire in 2017. Both FDA officials and industry representatives have already tagged the combination products review process as ripe for reform in conjunction with the recently started user fee negotiations.

In particular, agency officials have suggested the need for new user-fee-supported performance goals specifically targeting combination product reviews. (See Also see "Combo Product Reforms Are A Priority For Next User Fee Round, FDA Officials Say" - Medtech Insight, 24 June, 2015..) Industry is also pushing for legislative changes to redirect FDA's "primary mode of action" determinations in a manner that would allow more combination products to go through device, rather than drug, review pathways. (See Also see "Senate Bill Aimed At Streamlining Combo Product Regulation" - Medtech Insight, 20 July, 2015..)

FDA Says It's Taking Steps To Simplify Combo Product Consultations

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