FDA Unveils Updated Combination Products Effort

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By Michael D. Williamson

March 7 — An updated management plan for the premarket review of combination products at the FDA doesn't address how the agency intends to communicate with manufacturers, an attorney said March 7.

The Food and Drug Administration's plan, however, is very interesting and exciting, Bradley Merrill Thompson, a Washington-based attorney with Epstein Becker & Green PC, told Bloomberg BNA in an e-mail.

A March 7 FDA blog post announced the agency is launching a lean management model for the review of combination products.

Lean management should “build a better system for combination products review—one that’s more cohesive, more collaborative, and more systematic,” Nina Hunter, the FDA’s associate director for science policy in the Office of Medical Products and Tobacco, and Rachel Sherman, the agency's associate deputy commissioner in the same office, said in the blog.

Combination products are made up of combinations of a drug, device and/or biological product. They don't fit into the traditional categories of drugs, devices or biological products.


The new management approach is the FDA's next step in its efforts to “improve the overall efficiency, consistency, and predictability of combination product review,” the blog said. In October 2015, the agency released several recommendations on how to improve combination product review .

Lean management “begins with an analysis of what’s being done now, then designs a future state that eliminates waste and maximizes value,” the blog said.

According to the FDA, successfully implementing lean management depends upon meaningful interactions among all FDA offices and centers involved with combination products review. Active participation emphasized by lean management principles will ensure that the needed collaboration is present from the start, Hunter and Sherman said.

Combination product manufacturers currently face a somewhat cumbersome approach to premarket reviews. The FDA has certain centers for different types of products. For example, a drugmaker wanting to get a medication approved would submit its product to the FDA's Center for Drug Evaluation and Research (CDER) for review. A device maker, however, would submit its product to the Center for Devices and Radiological Health (CDRH) for review.

Reviews of combination products fall to a cross-center team of experts, but they are led by the medical product center responsible for the constituent part that provides the product’s primary mode of action, which, in the case of a syringe prefilled with a drug, would be CDER. However, the FDA's Office of Combination Products (OCP), within the Office of Special Medical Programs, oversees and coordinates the FDA’s regulation of combination products.


The lean management approach deserves wholehearted support, said Thompson, who is also the general counsel for the Combination Product Coalition (CPC), an industry group. He told Bloomberg BNA he didn't have time to consult with the CPC before commenting on the new management proposal.

“Obviously, from a resource standpoint, achieving efficiency is important,” Thompson told Bloomberg BNA, adding, “But we are even more excited about the goals of enhancing ‘communication and coordination among the groups that oversee the development, review, and approval of combination products.'”

However, Thompson criticized the agency for not addressing the need to communicate with outside groups.

Lean management shouldn't be strictly an internal exercise, and knowing when and how to coordinate reviews needs to involve the companies responsible for making the submissions, Thompson said.

To contact the reporter on this story: Michael D. Williamson in Washington at mwilliamson@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com