During a House Energy Committee hearing earlier this month, Rep. Debbie Dingell (D-MI) spoke about President Trump and Health and Human Services Secretary Robert F. Kennedy Jr.'s decision to cut a number of employees from the Food and Drug Administration.
00:00I now recognize the gentlelady from Michigan, Ms. Dingell.
00:05Thank you, Mr. Chair.
00:06Thank you for holding this important hearing on a range of critical public health topics,
00:12including the over-the-counter monograph drug user fee program that's expiring this year.
00:17I'm very proud to have helped led it with my colleague, Diana DeGette,
00:21and my two colleagues on the other side of the aisle in a bipartisan effort
00:25to create the program and its enactment in the CARES Act.
00:29Through discussions involving members, patients, doctors, pharmacists, and advocates,
00:34I'm glad we were able to take the first step towards reauthorizing OMUFA
00:40before it expires this year on September 30th.
00:43But as we work towards a reauthorization that will improve access to safe, effective,
00:49over-the-counter products, I'm very concerned about the ability to implement this reauthorization
00:55without a strong FDA workforce.
00:58In April, more than 3,500 FDA employees were laid off,
01:03a roughly 15% reduction in force.
01:07Secretary Kennedy has announced that he would reverse a portion of the broad cuts
01:12without specifying how this would occur.
01:15Firing key drug safety officials in the name of efficiency, I believe is short-sighted,
01:22it's not the way that our health care system should be run and that it risks American safety.
01:27The Trump administration has stated that anticipated cuts to the FDA workforce will not affect product reviewers or inspectors.
01:36Even if these positions are spared from terminations, gutting the agency workforce leaves them with more responsibility and fewer resources.
01:46The idea that they will not be impacted is simply not realistic,
01:50especially when the FDA is already understaffed and behind on inspection deadlines.
01:56Dr. Corrigan-Carray, I understand you can't answer questions about RIFs, so I won't put you in the position of asking you a question on that specifically.
02:07However, we do need to ensure the agency has necessary staffing to enable product evaluations without compromising FDA's dedication to scientific integrity, public health, regulatory standards, patient safety, and transparency.
02:24The user fees are central to that.
02:27So what I will ask is the impact on staffing if this program is not reauthorized on time.
02:34For example, what happens to staff and the workflow and availability of patients?
02:40Thank you for that question.
02:41You are correct.
02:42If this program was not authorized on time, approximately 44 percent of the scientists, reviewers, and others working in this area would have to be terminated.
02:52And what would happen is we would stop meeting on development programs.
02:56The proposed orders we have out, including the one on changing the dosage forms, would not get done and delay the new sunscreen that we're trying to work.
03:05We would miss those deadlines and we would fall back on the innovation that we're working on.
03:11So my colleagues, we've got to work together on this.
03:13As a co-chair of the Skin Cancer Caucus, I'd like to turn to the issue of sunscreen regulation and recognize we have skin care patients and advocates in the audience today.
03:25Thank you for being here and for your advocacy and dedication to the cause of skin cancer prevention.
03:30I have introduced a bipartisan bill, the Safe Sunscreen Standards Act, alongside my fellow co-chair, Representative John Joyce, which would streamline the FDA review process of the effectiveness and safety of new ingredients for non-prescription sunscreens.
03:47But we do want to make sure everybody's safe.
03:50Sunscreen is critical in the prevention of skin cancer, yet there are concerns that the current FDA regulations regarding sunscreen active ingredients aren't sufficient.
04:00There hasn't been an approved new active ingredient in sunscreen since 1999.
04:07You can go to Europe, you can get much better product than you can get here.
04:11Dr. Curran-Curray, I first want to get your opinion on the current situation of the sunscreen testing requirements.
04:17Do you see opportunities for Congress to act to alter the requirements on testing to increase the available active ingredient list?
04:27Thank you for that question.
04:28I think we're willing to work with you on legislation.
04:32We do want new sunscreens on the market.
04:35We want to make sure they're safe.
04:38We do have a new product.
04:39The first Omar was for a sunscreen.
04:41So we hope that, you know, perhaps we'll get, break that 1999 record.
04:45But, you know, these are drugs.
04:47And when we see that they're systemically absorbed at a rate that they could have systemic effects, we need to evaluate that.
04:55And we're willing to look at ways to evaluate it, provided we get the information that will allow us to determine it's safe.
05:01I'm going to submit more questions for the record because I'm out of time.
05:05But I do think we've got to figure out how the FDA balances health and environmental concerns with the need to access the most updated sunscreen technology and medicine.
05:15So I'm going to have questions for the record and yield back, Mr. Chair.
