Friday, January 27, 2017 11:00:34 AM
A potential President Donald Trump choice for US Food and Drug Administration (FDA) commissioner -
http://www.raps.org/Regulatory-Focus/News/2017/01/24/26670/Potential-Trump-FDA-Commissioner-Choice-A-QA-With-Dr-Joseph-Gulfo/
Gulfo: “I was commenting on Trump transition goals, if you will, about cutting red tape. I think the agency has the best intentions but there’s a fear – and even when they get it right they get beat up.
Out of that fear, the intent and letter of the original law [establishing FDA] is to promote health by ensuring safety and effectiveness [of medical products], but that has migrated over the years slowly and steadily…like a chronic, insidious disease. It’s been slow but I’ve watched it over my career. When I came into the industry – drugs were labeled for safe use and now there’s this absolute notion of safety, we’ve moved from safety and effectiveness… And now safety has become a discussion of benefit and risk and in big diseases, this has become long-term outcomes and survival. That’s all happened out of fear and is not in the regulations. What I’ve proposed is getting FDA back to safety and effectiveness..
The only way you’re going to get a meaningful impact is with combination therapies, so some nuance here: if we get things on the market that show activity with a biomarker, always start with safety, and some activity, at least some patients helped, then get them on the market and then they can be used in combination with other drugs coming onto the market. Change the path and get more products that may only be a single, or a single stretched into a double, but get more out there and then we might hit some grand slams."
Focus: Do you have any concerns that speeding up approvals and increasing approvals would put patients at risk?
Gulfo: “FDA has an awesome, daunting responsibility and no, we don’t want to compromise that. We want safe products. No buts about that. I always go to the mission of the FDA in the law: To promote health. A client once said: there’s got to be a balance. I believe safety and effectiveness with yes, continuing safety, observational studies to better inform the label, pull it or black box it or what not is the way to go. I don’t want toxic stuff out there. I believe you can do it without putting people in jeopardy. FDA gets hit from all sides, groups say they’re not doing enough or moving too slow."
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Phase1/2A proves Safety and Tolerability!!!!!
and that is exactly why SequestOx should have been approved. This was proven in the successful 163 person P3 Bunionectomy trial which had ZERO adverse events
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