WASHINGTON – U.S. Senator Johnny Isakson, R-Ga., today introduced legislation to make innovative medical treatments available to patients through a streamlined, efficient regulatory pathway.

The bipartisan legislation – the Combination Product Regulatory Fairness Act of 2015 – improves an outdated and inefficient regulatory process for innovative products that currently do not fall under a single categorization for approval by the Food and Drug Administration, or FDA.

“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” said Isakson. “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.”

Isakson’s legislation would 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 to prevent a duplicative regulatory process from stalling products’ accessibility to patients.

In addition to Isakson, the Combination Product Regulatory Fairness Act of 2015 is co-sponsored by Sens. Robert Casey, D-Pa., and Pat Roberts, R-Kan.

“This legislation will clarify the regulatory process for innovative treatments that do not easily fit into the current categories of FDA approval,” said Roberts. “As the Senate health committee is crafting its broader health innovation initiative, I’m proud to cosponsor this legislation to ensure this process is streamlined safely and efficiently so patients can receive the most cutting edge treatments without bureaucracy getting in the way.”

“This legislation will make the regulatory process for products that combine drugs and devices more streamlined and efficient,” Senator Casey said. “These products have tremendous potential, and this bipartisan effort will help encourage the development of these products while protecting patient safety.”

Background:

Currently, when approving products, the FDA does not take into account prior findings of safety and effectiveness of components of a combination product. The Combination Product Regulatory Fairness Act of 2015 will allow FDA to rely on prior findings of safety and efficacy for a previously approved drug component and rely on previously-approved pre-market approvals.  

Additionally, under the current process, sponsors are left with uncertainty as to what regulatory center will ultimately be charged with review of their application. 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.

###