President Trump's newest potential pick to head the Food and Drug Administration, Joseph Gulfo, MD, believes agency changes could help reign in high drug costs.
Dr. Gulfo is the executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University in Teaneck, N.J. He recently spoke with Regulatory Focus about his potential nomination and the state of the FDA.
Here are six soundbites from the interview.
1. On being considered for the role of FDA commisioner: "I don't want to speak out of turn, but I had some people approach me and had some discussions."
2. On cutting red tape: "When I came into the industry, drugs were labeled for safe use and now there's this absolute notion of safety. [W]e'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 … and we can do this one of four ways: with biomarkers, clinical science and symptoms (i.e. blood pressure, tumor size), with disease modification (bouts of migraines per month) and lastly with long-term outcomes."
3. On using the "Internet of Things" to share information: "When FDA laws were written, if you wanted to get something written into a scientific meeting, you had to do it 10 months in advance. But now, if you have something profound … you can get really earth-shattering news out really quickly. I'm not saying we should 'rely on it' but suggesting we live in a different environment of information dissemination and that has to be considered in the way drugs get approved."
4. On the length and complexity of the FDA's approval process: "I was at a biotech showcase recently and saw 95 companies in cancer, three-fourths of them developing a drug for acute myeloid leukemia and pancreatic cancer because there are significant, unmet needs there and these companies can gain incentives if they [earn] approvals ... but the pathway is so onerous that you're not even seeing the development."
5. On patient safety in regards to accelerated approvals: 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 don't want toxic stuff out there. I believe you can do it without putting people in jeopardy."
6. On the FDA's role in drug prices: "If approvals on a calendar basis were shortened, even by just two years, there are models that the contribution of development time to approval would mean less of a need for price increases and more exclusivity … those two years would reduce the development expenses and then with longer exclusivity, companies can recoup research and development funds easier. Also, more approvals is more competitors which equals lower prices."
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