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# PhRMA Seeks Improved Product Review to Prevent EpiPen-like Events
- URL: https://www.fdaweb.com/phrma-seeks-improved-product-review-to-prevent-epipen-like-events/
- Published: 2016-08-30T12:00:00.000Z
- Updated: 2026-09-14T21:28:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136648

An improved FDA combination product review and approval system could help speed needed products to market, like generic copies of Mylan’s EpiPen that has drawn a lot of attention lately due to allegedly unwarranted price increases, Pharmaceutical Research and Manufacturers of America (PhRMA) argues in a new blog post. With nearly 90% of all prescriptions filled in the U.S. with generics, “their timely approval is critical to patient access and long-term sustainability of our health care system,” the group says. “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.”

PhRMA also calls for new approaches for developing and reviewing combination products. “Innovator and generic biopharmaceutical companies face a range of challenges in developing combination products,” the group says. “ 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.”

PhRMA looks toward the recently proposed [Prescription Drug User Fee Act (PDUFA) VI](http://catalyst.phrma.org/what-you-need-to-know-about-pdufa-vi?ref=fdaweb.com) agreement for efforts that would address hurdles in bringing new combination products to market. “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,” PhRMA says. “Importantly, these improvements will not only enhance the regulatory framework that governs the development and review of combination products, but also increase competition.”