U.S. Sens File Bill To Streamline Combination Products Regulation

By Jof Enriquez,
Follow me on Twitter @jofenriq

Three United States senators have filed a bill that would streamline the current regulatory pathway for combination products, which are products that combine drugs, devices, and/or biological components. 

Sponsored by Sens. Johnny Isakson (R-Ga.), Robert Casey, (D-Pa.), and Pat Roberts (R-Kan.), the bill will allow the U.S. Food and Drug Administration (FDA) — when considering new combination products for approval — to review past studies about the safety and efficacy of drug components, and to rely on previous pre-market approvals. Currently, the FDA does not consider the prior safety and effectiveness profiles of combination products’ components, according to a news release. This legislation would require the agency to do otherwise, as its sponsors believe the expedited processs would save lives and promote investment opportunities.

“The Combination Product Regulatory Fairness Act of 2015 will eliminate the high level of uncertainty in approval standards that currently exists for innovative companies, both small and large, when deciding to invest in a new product,” Isakson said in the statement. “This bill creates a clear regulatory pathway for products to come to market that will directly translate to greater access and more innovative medical products for patients who will benefit most.”

Under the present regulatory process, a combination product under review, depending on its intended use and primary mode of action, is assigned to one of three product centers: the Center for Devices and Radiological Health (CDRH) for medical devices, the Center for Biologics Evaluation and Research (CBER) for biologics, and the Center for Drug Evaluation and Research (CDER) for drugs.

While this setup has worked reasonably well in the past, the evolving complexity of combination products are making it more challenging for the FDA to designate these products and for manufacturers to prepare appropriate product submissions.

"This legislation would assign a leader center within FDA to address whether a product is reviewed as a drug, device, or biologic, based off of the primary intended purpose for the product. Isakson’s legislation would allow sponsors to submit and work out an agreement with the FDA on a Combination Product Review Plan that details a clear regulatory process for the combination product, addressing necessary clinical studies, timelines, and an evaluation of incremental risks posed by the combination product," according to the statement.

Combination products — which include pre-filled syringes, drug-eluting stents, companion diagnostics, and the more advanced tissue-engineering products — are "clearly an area of rapid growth and great opportunity for medical device makers," states Michael Drues, Ph.D., president of Vascular Sciences, in a Med Device Online article. He says that one-third of all medical products under development today are combination products and, according to Research and Markets, the drug-device combination products segment will grow to $115 billion by 2019.

Facilitating this projected growth depends on a more streamlined, less fragmented regulatory pathway offered by the Combination Product Regulatory Fairness Act of 2015, according to bill sponsors.

“This legislation will clarify the regulatory process for innovative treatments that do not easily fit into the current categories of FDA approval,” Roberts stated. Casey added, “This legislation will make the regulatory process for products that combine drugs and devices more streamlined and efficient. These products have tremendous potential, and this bipartisan effort will help encourage the development of these products while protecting patient safety.”

Within existing mandate, the FDA has eased some processes regarding combination products. Specifically, it has issued guidance on current good manufacturing practice (cGMP) requirements for combination products, which allow device makers to create their own cGMP process and to follow selective compliance to requirements under certain allowable conditions.