FDA commissioner nominee stresses need to improve combination product reviews

Drug-eluting stents are a combination product that’s reviewed by the FDA’s devices arm (CDRH), while prefilled syringes go through the drug or biologics pathway, since the drug they contain is the key element.  The syringe is still regulated by the CDRH, though.

A recent legal decision does not support some controversial FDA decisions to regulate certain combination products as drugs, likely offering some relief to the industry.  However, regulatory snafus can and do continue afterward, regardless of a product’s designation as a drug or device, Dr. Robert Califf, the FDA’s deputy commissioner for medical products and tobacco acknowledged in a blog post, writing, “While we already have policies and processes in place to address such issues, we know we can do more.”  Califf has been nominated to be the new full-time commissioner of the FDA, so his interest in the topic is all the more significant.

Citing a lack of coordination and communication between the FDA’s drug, devices and biologics arms (at least two of which play a role in all combination product reviews, by definition) and poorly justified decisions by FDA regulators, a survey by the Combination Products Coalition last year found that 70% of product sponsors reported delays during the combination product review process.  One-third of the delays lasted at least a year.

Along with co-author Jill Hartzler Warner, the FDA’s associate commissioner for special medical programs, Califf promised to implement reforms in a just-released internal report on combination product reviews.  The reforms are rather mundane, reflecting the need to overcome excessive bureaucracy within the agency and break down internal silos.

They include the establishment of clear guidance on combination product reviews (meaning the creation of more guidance documents), simplified and access to data systems across the FDA’s three arms, the creation of a “combination-product-specific organizational chart and contact directory” and the “establishment of a mechanism for estimating time spent on intercenter consults so resources can be allocated appropriately to organizational units to assure adequate review performance.”  In addition, the report called for an update to the Intercenter Consult Request form.

Califf and Warner note in the blog post that Congress has taken up the issue in the 21st Century Cures bill to reform regulation of the life science industries, though it appears the emphasis of the act is on the initial product designation decision, rather than the day-to-day realities of regulating products across centers. The bill is awaiting a vote in the Senate after passing easily in the House.  “Some improvements are already in place and others will be coming this year and next.  We continue to want to hear your ideas for enhancing how we work with you on combination products.  We are listening–and excited to do our part by evaluating innovative combination products and helping to improve the well-being of patients by approving new safe and effective therapies,” Califf and Warner write.

REFERENCE:  Fierce Medical Devices; 19 OCT 2015; Varun Saxena

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