MURPHY SECURES COMMITMENT FROM FDA NOMINEE TO CONTINUE CRITICAL WORK ON SESAME LABELING, ELECTRICAL STIMULATION DEVICES ON CHILDREN, TRANSPARENCY

WASHINGTON—At the nomination hearing of Dr. Stephen M. Hahn to become the commissioner of the U.S. Food & Drug Administration (FDA), U.S. Senator Chris Murphy (D-Conn.), a member of the U.S. Senate Health, Education, Labor and Pensions Committee, questioned Dr. Hahn on his priorities if confirmed to be the next commissioner of the FDA. During his questions, Murphy secured a verbal commitment from Hahn to continue some of the work of his predecessor, including the FDA moving to consider labeling products that contain sesame, following a letter Murphy sent to former Commissioner Scott Gottlieb after a hearing directly from Connecticut families about the lack of sesame labeling; and moving forward with an FDA proposed rule to ban electrical stimulation devices on children. They also discussed the need to better understand the gaps in innovation and advancements in mental health treatment options.

Murphy asked: “I just want to get your commitment on the record to continuing to work on them if you are confirmed for this post. The first is an FDA current proposed rule to ban electrical stimulation devices. These are devices that have been used in many cases on children with little efficacy and many long term negative side effects. The second is the increasing propensity of children to show allergy to sesame and there is a conversation happening about labeling sesame, as one of the regulated allergens through FDA. Can you just commit to me, again, in public to continue to work with us on both of these issues?”

Hahn responded: “Senator, if I'm fortunate enough to be confirmed, I commit certainly to working with you on those both of those issues.”

A complete transcript of Murphy’s exchange with Dr. Hahn is below:

MURPHY: “Handful of questions. First, we had the chance to talk privately about two priorities of mine, and I just want to get your commitment on the record to continuing to work on them if you are confirmed for this post.

“The first is an FDA current proposed rule to ban electrical stimulation devices. These are devices that have been used in many cases on children with little efficacy and many long-term negative side effects. The second is the increasing propensity of children to show allergy to sesame and there is a conversation happening about labeling sesame, as one of the regulated allergens through FDA. Can you just commit to me, again, in public to continue to work with us on both of these issues?”

HAHN: “Senator, if I'm fortunate enough to be confirmed, I commit certainly to working with you on those both of those issues.”

MURPHY: “Second, we've had a problem in other areas of the administration where information is often readily shared with Republicans, but is withheld intentionally from Democrats. That was not the case with your predecessor. Scott Gottlieb was, I think, very good about making sure that both Republicans and Democrats were informed a little bit easier on the FDA, because there's not a lot of politics that plays into the decisions that you make. But I just want to make sure that you'll commit to this committee to work with all members, Republicans and Democrats, to share updates and to gather input without regard for party.”

HAHN: “Senator, I commit to that. As you and I discussed in your office, many of these issues are not party based. They're bipartisan, and I certainly commit to that, sir.”

MURPHY: “And lastly, I certainly agree with your testimony. This is really exciting time for American medicine and science. But we have a drug and device manufacturing system that is rewarded, really solely for bringing to market products that can lead to strong profits. And often we talk about this in the context of rare diseases that go unmet by drug discoveries. But, you know, frankly, the real scandal is that even in many common disease states, we've had very little innovation. And as someone who works a lot on mental health, it's remarkable how little innovation we have seen over the last 50 years when it comes to drugs that treat depression, for instance, which you know, is a common disease state, inflicted upon millions and millions of Americans. In fact, this year was the first time in decades that the FDA approved any new major depression drugs. And so you're in a really unique position as a physician to bring together clinicians and patients and other stakeholders to hear about how these gaps impact patient care.

“So if you're confirmed, what kind of things do you think you can do at the FDA to identify those areas of medicine where we just haven't seen advancements in treatment options, especially when it comes to mental health, where people are crying out for additional treatments and drugs?”

HAHN: “Senator, thank you for the question. And you're right—mental health we have lagged behind in terms of innovations. I think the other area are the neurodegenerative disorders, ALS, etc., Parkinson’s disease. And these are areas where there is fantastic research going on. I don't understand completely why there is this gap between that research and product development. I know that there are best practices at the agency with respect to some areas, and I look very much forward to working with you and Congress, finding how we can spread those best practices across all of the different units of the agency.”

MURPHY: “I had one of the few major pharmaceutical companies that is investing some major money in mental health drug development pathways and, they identified patient and human testing as an area that they really saw opportunity for reform in. Once you got a drug into those tests, it was much harder to prove efficacy than it was for other disease states. And, you know, that's certainly something that you and FDA can work with these companies on trying to reform and perfect.”

HAHN: “Senator, this is an area of particular interest to me. As you know, I'm a clinical trial list, and what endpoints we use in clinical trials, which is exactly what you're getting. It could help actually expedite some of this medical product development. We have to be pragmatic, but we also have to make sure that they're validated endpoints. I'm very interested in working with all stakeholders on this.”

MURPHY: “I hope you'll allocate sufficient time and attention to it. It could really use some leadership from the top. Thank you, Mr. Chairman.”

###