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Congress Ensures New Drug Review Program Remains Funded

Federal review of new drugs and devices should continue to happen in a timely manner, thanks to the recent reauthorization of user fee amendments by Congress.

Federal Drug and Device Review

The Food and Drug Administration is responsible for determining whether new medical devices and prescription drugs, including generics, are safe and effective for patient use. That work is funded in part by fees manufacturers pay to have a drug or device application reviewed.

User fee amendments, sometimes shortened to “UFAs,” allow the FDA to accept these fees. In turn, the FDA can acquire new expert resources, which allow the agency to improve and evolve its processes to better meet the changing needs of drug review.

Improving Access to Generics

The generic drug user fee amendment is the rules and fees agreement specifically for generic drugs. It first passed in 2012 with the goal of improving access to safe, high-quality and affordable generic medications. And it has proven valuable. In the United States, nine in 10 prescriptions that are filled are for generics.

The recent reauthorization of this user fee amendment represents an agreement between industry and the FDA to continue supporting timely review of generics – even as the medications get more complex. Aptly named, complex generics are often a combination of two chemical medications. The term can also apply to the use of a medication in combination with a device.

Review of complex generics is more complicated than review for simple chemical molecule drugs. A generic inhaled medication, for example, requires not just review of the medication, but also of the delivery device.

Putting Patients at the Center

In preparation for the reauthorization process and to help inform the next evolution of generic drug review, the FDA held a series of listening sessions with patient advocacy organizations.

The Generics Access Project used the opportunity to emphasize the value of patient input in FDA’s priority setting. The group also requested that the federal agency prioritize its review of applications for the first and second generic of a specific medication. Introducing those will likely yield a greater benefit than, for example, a sixth or seventh generic option for the same medication.

A generic medication can cost 80-85% less than its brand-name counterpart, generating savings to both patients and the broader health system. Now, with the FDA’s review resources secured, even more generics – and complex generics – can be reviewed timely, and even greater savings are possible.

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