Enhance patient and advocate views to FDA risk-benefit decision-making processes

As we posted last week, The Pink Sheet and FDA News are reporting that the FDA and industry representatives from PhRMA and the BIO have reached an agreement on the reauthorization of the Prescription Drug User Fee Act (PDUFA V) - the first major milestone in the reauthorization process. The letter deals with a lot of technical issues, and we thought it would be helpful to explore what those really mean for patients:

Enhance patient and advocate views to FDA risk-benefit decision-making processes

One issue the FDA must consider when reviewing any new medicines is weighing the level of benefit versus the level of risk to potential patients. While medicines bring benefits to people, all drugs have risks. During the drug development process, the benefits and risks of medicines must be considered together and weighed against benefits and risks of not treating or not preventing the condition. How the benefits and risks are assessed, and which stakeholders can participate in that discussion, will be an important piece of the next PDUFA agreement.

According to the March 31, 2011 meeting minutes from FDA and Industry negotiations over PDUFA V, the new PDUFA technical agreement tentatively includes a provision that will enhance benefit-risk assessment in regulatory decision-making - including concentrating on patient-focused drug development. Patients remain strong advocates for new drug development and their voices can be helpful during the FDA review process. This provision is part of a solution that will result in more timely, balanced and higher quality decisions by the FDA.

As the PDUFA reauthorization process moves forward, this is a topic we will be watching closely. Timely access to new, innovative medicines is good for all patients. This proposed change will help meet that goal.