Senate Bill Seeks to Streamline Regulatory Approval Process for Combination Medical Products

July 28, 2015—United States Sen. Johnny Isakson (R-Georgia) announced a bipartisan bill, Combination Product Regulatory Fairness Act of 2015 (S. 1767), that seeks to make innovative medical treatments available to patients through a streamlined, efficient regulatory pathway. The bill, which is cosponsored by Sen. Robert Casey (D-Pennsylvania) and Sen. Pat Roberts (R-Kansas), was introduced in the Senate by Sen. Isakson on July 15th.

In a press release, Sen. Isakson asserted that the bill would improve an outdated and inefficient regulatory process for innovative products that currently do not fall under a single categorization for approval by the US Food and Drug Administration (FDA). The legislation is designed to implement a transparent, innovation-friendly, and risk-based approach to regulation while improving efficiency through greater certainty in the interpretation of regulatory standards in the approval pathway. Finally, this legislation emphasizes the ability of manufacturers and the FDA to rely on existing safety and efficacy data for a previously approved drug component and to rely on previously approved premarket approvals to prevent a duplicative regulatory process from stalling products’ accessibility to patients.

Additionally, the legislation would assign a leader center within the FDA to address whether a product is reviewed as a drug, device, or biologic, based on the primary intended purpose for the product. Sponsors would be allowed to submit and work out a Combination Product Review Plan with the FDA that would detail a clear regulatory process for the combination product, addressing necessary clinical studies, timelines, and an evaluation of incremental risks posed by the combination product.

In the announcement, Sen. Isakson stated, “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. 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.”

Sen. 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.”

In a statement from the Advanced Medical Technology Association (AdvaMed), Stephen J. Ubl, the organization’s president and CEO, commented, “Combination products—whether device/drug, device/biologic, or drug/biologic—represent some of the most innovative treatment options for American patients. Unfortunately, FDA’s process for determining which of its centers has primary responsibility for reviewing these products, as well as the actual review itself, often lacks predictability and efficiency, delaying patient access to these cutting-edge advancements. AdvaMed commends Sens. Johnny Isakson, Robert Casey, and Pat Roberts for introducing legislation that seeks to address this complex issue. We look forward to working with Congress, FDA, and other key stakeholders to move this legislation forward.”