Harnessing the power of real-world evidence to benefit patients through PDUFA VI

Learn more about how real-world evidence can advance medicine.

Andrew PowalenySeptember 6, 2016

Harnessing the power of real-world evidence to benefit patients through PDUFA VI.


America’s biopharmaceutical researchers are in a golden era of medical research, discovery and development for patients. Rapid advances in technology and science have enhanced our ability to use data to discover important insights on the use, benefits and risks of medicines.

Some of these data are gathered from the real-world practice of medicine and are called real-world evidence (RWE). This type of data can come from a variety of sources, including physician electronic health records, payer administrative claims or patient registries.


Greater use of RWE could lead to more efficient drug development programs, provide more robust information about the benefits and risks of new medicines and can ultimately lead to quicker access to innovative, safe and effective medicines for patients.

To help unleash the promise of RWE, the Prescription Drug User Fee Act (PDUFA) VI reauthorization will provide additional resources to the U.S. Food and Drug Administration (FDA) to help develop a better understanding of how it can be used to benefit patients. Specifically, PDUFA VI aims to clarify the contexts within which RWE may appropriately be used in regulatory decisions by establishing a public process for stakeholders, including patients and academics, to provide their input to the FDA as it develops guidance on RWE analyses. This will strengthen the scientific rigor of these analyses, define appropriate use of the available information and foster efficiencies in drug development, thereby helping to make safe and effective medicines available to patients quickly.

Today, the United States leads the world in delivering new medicines to patients, thanks in part to PDUFA. Since 1993, the program has provided more timely access to more than 1,500 new drugs and biologics, including treatments for cancer and rare, cardiovascular, neurological and infectious diseases. It is critical that Congress reauthorizes the PDUFA program before its expiration in September 2017.

To find out more about RWE, check out our RWE fact sheet. You can also learn more about PDUFA VI and its key provisions by viewing our PDUFA VI fact sheet and recent blog post What you need to know about PDUFA VI.

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