Regular visitors to MedShadow know that as a nonprofit organization, we strive to make the voice of the patient heard more — not only by doctors, but by regulatory agencies, especially the FDA, as well. So I was pleasantly surprised last week to see the FDA publish a statement from Commissioner Scott Gottlieb dealing with “new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making.”
Any effort to give patients more of a say in the development of drugs and medical products, as well as regulatory decisions, is a positive. Gottlieb’s statement was quite long, but the crux of his message, as it relates to patients, follows:
I couldn’t agree more. And as Gottlieb mentioned, the FDA has held Patient-Focused Drug Development (PFDD) meetings in over 20 disease areas, such as opioid abuse, HIV, autism and Parkinson’s. Bravo to the agency for holding these meetings. The agency also came out with reports on what they learned from patients; you can read more about it here.
Next Topic: Chronic Pain
The next PFDD meeting is scheduled for July 9 and will focus on chronic pain. The meeting will be webcast, and you can submit comments related to the meeting through September 10. If chronic pain is an issue for you or someone you love and you have something to say, this is your opportunity to have your voice heard.
While it’s fine to have patient meetings to collect patients’ input, the big question is, will drug developers be listening to and incorporating these patient concerns? It’s hard to say. However, the FDA did issue new guidance for stakeholders to do just this. You can take a look at it here if you like.
The bottom line is that the FDA is giving patients more and more input in the drug development process. If there’s a disease area you are concerned with or have strong feelings about, speak up. It could provide valuable insight for a new drug.