FDA Empowers Patients to Speak Up

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Better patient outcomes start with increased patient engagement. The fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V), under the Federal Drug Administration Safety and Investment Act, promises to achieve this goal. Last week, as the FDA concluded a two-day public workshop, this promise took another step toward becoming a reality.

This public workshop gave patients and their advocates a better understanding of the FDA's benefit-risk assessment process, where the FDA weighs the benefits of a new medicine against its potential risks. The benefit-risk assessment plays a critical role in the FDA's decision whether to approve a new treatment for public use. Generally, the FDA must decide to approve a new medicine based on limited data that attempts to predict the potential effects of the medicine on the general public.

However, patient input at this stage of the process can help regulators make this determination, and the PDUFA V agreement gives patients more opportunities to have their voices heard. Through public workshops like this one, patients and advocates can tell the FDA what they need from future treatments. This information can impact the way regulators view a medicine's benefits during the assessment process.

Last week's public workshop provided just one of the many opportunities patients have to make their voices heard. With 13 additional public disease area meetings scheduled through 2015, patients have an unprecedented opportunity to impact the types of treatments available to them in the future. For those patients who want to have a voice in the process, the FDA needs you to get involved.

Comments

Why does FDA drag their feet on medications already approved in Europe? They have taken 20 years to approve a medication and still find out it has sometimes devastating affects. Stem cells should be used and approved so insurances will cover it. We already know the benefits out weigh any side affects.