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  • 7/3/2025
During a House Energy Committee hearing last week, Rep. Thomas Kean (R-NJ) asked Health and Human Services Secretary Robert F. Kennedy Jr. about layoffs at the Food and Drug Administration.

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00:00The chair now recognizes the last member of the subcommittee, the gentleman from New Jersey,
00:07Representative Keene, for five minutes of questioning.
00:09Thank you, Mr. Chairman. And I want to thank Secretary Kennedy for being here today.
00:16I am very interested in learning about the plans for restructuring and streamlining at HHS.
00:21I'm especially interested to hear how these changes will improve New Jersey's impressive
00:27biopharmaceutical industry. Right now, there are many innovators in my district who are developing
00:33treatments to diseases that currently have no treatments, or they're improving the quality of
00:39life of patients around the country by developing improvements to existing therapies. New Jersey's
00:45innovators should be proud of their work, and Congress and HHS should do everything that we can
00:50to enable this innovation to benefit patients. Secretary Kennedy, in your testimony, you discussed
00:57the changes happening across HHS, and I'm hopeful that your efforts can improve processes across
01:03your department's various agencies. I've heard from stakeholders in New Jersey about these changes,
01:09and they could impact the prescription drug approval process. Could you speak to how you are looking
01:14to ensure that these changes have no negative impact on drug application review and approval
01:20timelines, new guidance, or general FDA response times to drug sponsors?
01:25Are you talking about the personnel changes? They're not going to have any impact, and we
01:31have met repeatedly with the biotech industry, including people from New Jersey,
01:37to assure them of that. We want to light a fire under biotech in this country, and that's exactly what
01:43we're going to do. It is the future of medicine. The stuff that is happening, the developments and innovations
01:49that are happening in that space should be exciting to all of humanity, and we're going to make sure
01:55that the United States remains the center of the biotech revolution. China is putting huge amounts of
02:04money into this space, and it's important that we do the same thing. We're going to try to take down,
02:11dismantle the barriers to biotech development and approval, and to make sure that we do everything
02:18that we can to support that industry. Thank you. Second question, Secretary Kennedy. I appreciate
02:25your comments earlier on innovation and the role that cell and gene therapies play in that space.
02:31However, we must not forget the innovation that continues in the small molecule drug space,
02:37especially since these drugs can often be more convenient for patients. So amidst changes at
02:42FDA over the past several months, including the Centers for Drug Evaluation and Research, how are you
02:49ensuring that FDA can continue to enable innovation and flexibility in its reviews and approval of small
02:56molecule drugs? I mean, that is a delicate path that I think we all have to talk about. We have to work
03:05work with Congress to reform the pill penalty, and there is a provision in that in the Big Beautiful
03:13Pill, and it's something that Congress ultimately is going to decide. We want to make sure that,
03:21you know, it's the small molecule drugs that you can take at home, the pills that the elderly consume in
03:28this country, and we want to make sure those are available and that those are at a convenient cost.
03:34And to some extent, the pill penalty has dampened innovation in that space, and a lot of the
03:42money has, the investment money has moved to the large molecules, the long molecule space,
03:50and, but it's a delicate balance. And, and we try to resolve that in the Big Beautiful Bill. I think
03:57it's something that both sides of the aisle have an interest in, and that we all ought to be trying to
04:02strike the right balance. I look forward to working with you in that regard, legislatively or
04:08administratively. Earlier this year, Secretary Kennedy, the administration issued an executive
04:14order that called for you and the FDA commissioner to look at administrative and legislative
04:20recommendations to improve the process by which prescription drugs can be reclassified as over-the-counter
04:26medications. This is commonly referred to as switch and important to me since New Jersey has a number of
04:35over-the-counter drug manufacturers. How can we work together to make sure that FDA approaches its work
04:41on OTC medicines, including switches, in a common sense and least burdensome manner to make sure that we realize
04:48the full potential of OTC benefits for American consumers? This is an opportunity that we're
04:53deeply interested in, that we're committed to at FDA, and I would urge you to talk not just to me, but to
05:01Marty McCary about that. I think you'll be very, very gratified by the interest, by his openness to those
05:09kind of innovations. The gentleman's time has expired. Thank you, Secretary. You're back.

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