FDA Taking Steps To Simplify Combo Product Consultations
This article was originally published in The Tan Sheet
Executive Summary
The agency releases an internal assessment of how it handles inter-center consultations for combination products. As expected, there are some serious challenges to collaboration between the centers, but FDA says it is taking tangible steps to make it better.
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 released by the agency Oct. 14.
The agency's Office of Planning launched the assessment 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 chart below), a significant portion of which are initiated as questions by drug center reviewers to the device center about human factors issues (Also see "Human Factors Questions Drive Rise In FDA Inter-Center Consults" - Medtech Insight, 7 May, 2015.).
Improving inter-center consultations on combination product proposals could help FDA and drug makers generate results from the agency’s Nonprescription Safe Use Regulatory Extension initiative on making OTC approvals contingent on “conditions of safe use” specific to each product, such as requiring the availability of a diagnostic technology suitable for use by consumers or pharmacists. Under its current regulations FDA could evaluate a novel OTC proposal including a device as a combination product, which is cross-labeled so the instructions on each component of the switch state it must be used with the other (Also see "Combination Products Offer Regulatory Option For Novel Switches" - Pink Sheet, 23 Apr, 2012.).
The internal study affirmed what many in industry and at the agency say they already knew: "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 already is 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 the agency is simplifying IT access across the agency, taking steps to make it easier for staff to request and monitor inter-center consults, and 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 inter-center consults as a means to improve resource allocation.
The 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 (Also see "Combo Product Reforms Are A Priority For Next User Fee Round, FDA Officials Say" - Medtech Insight, 24 Jun, 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 (Also see "Senate Bill Aimed At Streamlining Combo Product Regulation" - Medtech Insight, 20 Jul, 2015.).
[Editor's note: “The Gray Sheet” also published this article. "The Tan Sheet" brings selected complementary coverage from our sister publications to our subscribers.]