A bill was introduced in the U.S. Senate last month entitled, “The Combination Product Regulatory Fairness Act of 2015.” The bill is intended to streamline device/drug combination registrations at FDA by letting the agency rely on prior PMAs and approved drug findings to help support new product approvals.
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.