FDA’s recent public meeting on June 10th discussing a user fee program for over-the-counter (OTC) drugs indicates new activity in this program. Expert opinion was heard at the meeting with the acknowledgement that this is a very enormous undertaking with a small staff of 18 employees to manage. The idea is that implementing a user fee program may result in great benefits and advances in over-the-counter drugs to help us manage symptoms and conditions safely without the oversight of a doctor.
Zachary Brennan, RAPS, posted an article that has additional informative links that follow the current FDA activity on this topic. Brennan indicates that FDA is still seeking input/perspectives from stakeholders as they work toward a more defined approach. Help them take a first “bite” into this huge project by commenting.