Murkowski Questions FDA Nominee
Washington, DC – U.S. Senator Lisa Murkowski (R-Alaska) today questioned the President's nominee to be Commissioner of the Food and Drug Administration (FDA), Martin Makary, during his appearance before the Health, Education, Labor, and Pensions (HELP) Committee. Murkowski raised the FDA’s handling of the Vaccine Advisory Committee, the handling of clinical trials for rare diseases, and funding for state and local governments to conduct food safety inspections.
Full Transcript:
Senator Murkowski: Doctor, welcome, it was a good conversation that we had, and I appreciated that. I thank you for the encourage to read that provision in your book, it was great airplane reading for me.
Dr. Makary: Thank you, Senator.
Senator Murkowski: I also want to thank you for the assurance you gave to Senator Collins regarding the Vaccine Advisory Committee, and ensuring there would be meetings going forward. I think for several of us who had I thought good substantive conversations with Secretary Kennedy, we had received assurances about things like the vaccination committee. So, we’re making sure again that important input goes forward is important to many of us, so I appreciate that.
I wanted to talk to you this morning about an issue we discussed in my office, and that is with regards to ALS. The FDA’s accelerated approval pathway has really been important, and I think very promising for treatments for ALS and some other rare diseases. You have advocated for using common sense alongside science in regulatory decisions. So, very briefly, how do we define common sense here as it applies to the regulatory decisions of the FDA. How do we make sure that ALS patients who are looking at a very, very limited time frame, they can’t wait for the traditional approval process, there are some emerging measures using digital technologies, is this in your realm of common sense? Give me a little bit of insight here on how you would like to proceed on these approval pathways.
Dr. Makary. Thank you, Senator. I very much enjoyed our time together, and talking through a bunch of these issues. We have to customize the regulatory process to the condition that we’re trying to be able to offer hope, so, if a condition affects 19 people in the world as a partial triplication chromosome 15 disorder does, or a disease that affects 52 kids in the world, we cannot require two randomized control trials. We have to customize the regulatory process to what we’re trying to do if our goal is to try to provide safe and effective therapies. So, I do believe firmly in that approach, and I do think we can use some commons sense to ask some big questions we’ve never asked before at the FDA. Why does it take 10 years for a drug to get approved? Why does a college student who suffers from chronic abdominal pain for years, and we have no idea what’s going on, and they go to Italy for a summer and they are suddenly cured of their abdominal pain? Why does a peanut allergy medication that’s been safe with data for decades get approved in Europe before the United States when nearly 10% of our population has a food allergy? So, I do think there’s a lot of areas where we can ask, does a drug need to be prescription, when it could be over-the-counter, why are requiring continuous glucose monitors to have a Doctor’s prescription when it’s good for people to use these monitors and learn about what they’re eating. We don’t just want to limit continuous glucose monitoring to people with diabetes, we want to prevent diabetes when 30% of our nation’s children has diabetes or pre-diabetes or some form of early insulin resistance. Why are we holding these tools to help people, empower them about their health, until after they’re sick, same with continuous blood pressure monitoring.
Senator Murkowski: Well, as you point out, why do we wait. We want to make sure that there is a level of safety, that’s the job there through the FDA. But, again, being able to accelerate these in ways that are meaningful, and to your point, that actually fit with the population that you’re speaking to. So know that I’m going to be pushing you on this, as well as many other advocates out there.
Dr. Makary: Thank you.
Senator Murkowski: I want to quickly ask you about food safety inspections. State and local governments conduct about 60% of food processing facility inspections, 90% of produce safety inspections, 100% of retail food inspections. What has happened is we have seen in the Biden Administration, FDA planning to cut funding for state and local food safety programs. This impacts us in the state of Alaska when it comes to our seafood industry, and in other areas. So, I’m looking for a commitment from you that under the Trump Administration, the FDA is going to maintain funding for these contracts with state and local governments. They’ve proven that it’s more cost effective, more efficient, and it also is what Congress has asked for. So I’d like to know that you’re going to be supportive in that regard to state and local governments.
Dr. Makary: I’m happy to look at that with you, Senator.
Senator Murkowski: Very good. Thank you, Mr. Chairman.
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