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The FDA Needs to Hear From You!

At Pfizer, patients come first. That’s why it’s critical that we hear from patients like you to learn what you need – now and in the future – when it comes to developing safe and effective new medicines.

Each and every person is unique, as are the challenges they can experience from illness – and drugs need to be developed with patients’ perspectives in mind. Our vision is to integrate patient perspectives into all elements of research and development, from the earliest lab studies and clinical trials to those done following the launch of a new therapy.

In recent years, patients have played an increasingly integral role in pharmaceutical research and development – and scientific advances show they’re making a real difference. To build on this progress, the U.S. Food and Drug Administration (FDA) has hosted twenty disease-focused public meetings since 2012 to better understand patient perspectives on how their disease impacts their daily lives, the burden of symptoms, availability or lack of treatment options, and perspectives on benefit/risk tradeoffs related to potential new therapies. These meetings were part of a program implemented under the Prescription Drug User Fee Act (PDUFA), a law that supports FDA’s ability to regulate safe and effective medicines for patients.

Most people have never heard of PDUFA, but the law provides resources to the FDA to make sure new drugs are reviewed promptly and made available to patients in a timely manner. Initially signed in 1992, the bill is reauthorized every five years, often with improvements to the review process for new, potentially life-saving, medicines.

The law is up for reauthorization this year, and there is a lot at stake. While the public meetings held in 2012 were widely seen as a positive step in incorporating patient perspectives, this practice has not yet been incorporated into FDA’s formal review process. In the new version of PDUFA, there are provisions that will further develop new scientific methodologies to integrate patient input into the regulatory decision-making process.

When it comes to creating innovative new drugs, patients’ voices need to be heard from start to finish. You can help ensure the newest version of PDUFA is reauthorized this year. We can’t afford to turn back on our progress. Want to stay informed on Congress’s progress on this law? Sign up for Ready for Cures below.