Improving FDA’s combination product review process could increase epinephrine auto-injector competition

Stephen J. Ubl
Stephen J. Ubl August 30, 2016


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Combination products that consist of a medicine and delivery device are important treatment options for patients and have the potential to improve public health. Innovator companies invest in pioneering research to bring new combination products and medicines to patients, and over time those medicines become available as lower-cost generic versions. With nearly 90 percent of all prescriptions filled in the United States with generics, their timely approval is critical to patient access and long-term sustainability of our health care system.

To help increase access to generic medicines, including combination products, we need the U.S. Food and Drug Administration (FDA) to bolster support for the development of new combination products, such as epinephrine auto-injectors, by improving the review process and continuing its efforts to address the backlog of new generic drug applications. We should also explore financial incentives that could encourage generic entry, such as a targeted grant program to support generic manufacturing investments and maintain production for eligible products. Focusing on pragmatic solutions such as these will enhance the private market and ensure we continue to deliver innovative treatment options to patients.

We also need to address the regulatory framework that governs the development and review of combination products. Innovator and generic biopharmaceutical companies face a range of challenges in developing combination products. These include but are not limited to: additional dosing and other scientific studies that may be required for approved medicines being delivered through the use of a device; and different regulatory paradigms for medicines, biologics and devices that result in inefficiencies and make review processes more complex as companies must work with multiple FDA review centers.

Through the proposed Prescription Drug User Fee Act (PDUFA) VI agreement, America’s biopharmaceutical research companies support efforts that would address the hurdles in bringing new combination products to the marketplace. These include the use of an independent third-party review to improve the FDA’s combination product review process, building FDA staff capacity and access to scientific expertise and improving coordination among FDA’s review centers. Importantly, these improvements will not only enhance the regulatory framework that governs the development and review of combination products, but also increase competition.

Learn more about PhRMA’s policy solutions for reducing the generic backlog and incentivizing competition here.

Read more about how PDUFA VI will benefit patients, advance medical innovation and build a more effective FDA at www.phrma.org/PDUFA.  

Topics: Research and Development, FDA, PDUFA, FDA Modernization, Policy Solutions