'We Want The United States To Lead': Bob Latta Urges Sunscreen Improvements To Catch Up With Europe

4 months ago

During a House Energy Committee hearing before the Congressional Recess, Rep. Bob Latta (R-OH) asked Acting Director for Center for Drug Evaluation and Research at the FDA Dr. Jacqueline Corrigan-Curay about sunscreen innovation.

Transcript

00:00The gentleman from Ohio.

00:06Well, thank you, Mr. Chairman.

00:08Mr. Latos, recognized for five minutes.

00:10Multiple things here this morning.

00:12Hold the clock for just a second.

00:14Let him at least get turned into his pay.

00:16I just did the same thing upstairs.

00:18I apologize to our witnesses, but we have multiple hearings going on,

00:21and we're trying to let every member who is interested in the subject matter ask their questions.

00:26I just ran upstairs to the Environment Subcommittee and asked my questions and ran back down here.

00:31I appreciate my vice chair filling in and helping me out.

00:35We both did that at some point today, but I appreciate our witnesses.

00:39Now, I believe the gentleman is ready.

00:42Well, thank you, Mr. Chairman, and I appreciate your indulgence.

00:46To our witnesses, thank you very much for being here today.

00:49This is a really important hearing, critical to public health, workforce, rural health,

00:55and over-the-counter medicines.

00:58The over-the-counter monograph drug user fee program, AMUFA,

01:02at the Food and Drug Administration gives consumers access to manage their own care

01:06in a safe and affordable manner.

01:09Five years ago, I worked with my energy and commerce colleagues

01:13to modernize how the FDA regulates most OTC medicines

01:18with the enactment of the AMUFA program.

01:22These revolutionary changes made the 40-year-old system more efficient, transparent,

01:28and open to innovation.

01:30I'm very proud to once again be leading this reauthorization of such a critical program.

01:36The AMUFA program has drastically reduced the burden on our health care system

01:40by lowering the number of visits consumers need to make to a doctor

01:43to obtain a prescription for a simple treatment.

01:47Again, five years ago, when Congress initially passed my legislation to reform OTC monographs,

01:53I entered into the record a statement of intent on data required

01:57for general recognition of safety and effectiveness for non-prescription drugs.

02:02The statement reads,

02:03Unfortunately, in the five years, I'm concerned that the FDA has not fully acted in accordance

02:20with the congressional intent by requiring superfluous information.

02:26I'm concerned that these delays, the innovation prevents consumers from benefiting from new

02:31and improved products.

02:33If I could ask my first question to Dr. Corrigan-Couray,

02:40I hope I pronounced that properly.

02:42In the last five years, how has FDA worked to improve the process for expediting the review

02:47and administrative order process for monographs?

02:52In this first five years, what we've done is we've changed this from a paper-based rulemaking

02:56to an electronic communication system.

02:59We've given fundamental guidances so the expectations are very clear.

03:04We've started meeting with companies on their programs.

03:07We're meeting all those goals.

03:09We have the first Omar for a sunscreen.

03:11We've issued 33 final orders, and we have five proposed orders to update some of the safety labeling,

03:19as well as a new proposed order that would allow innovation in terms of dosage form.

03:25So you could go from tablet or capsule to an oral disintegrating or a chewable,

03:30and so that would allow children and those who have trouble swallowing.

03:34So we've done a lot.

03:35There's more to do.

03:37And in MUFA II, we want to provide more opportunities for interactions with the FDA and companies

03:42so they know our expectations, looking at their protocol synopsis.

03:45We'll work on issues in quality.

03:48We'll work on transparency, transparency in exclusivity, transparency in fees,

03:52and who's paying the fees and who's not paying the fees.

03:55So we think we're on a good path to continue this innovation.

03:58Just to follow up on that, what's your timeline?

04:01Because you said there's more things to do and more to get these things through the process.

04:06Is there any kind of a timeline that you're anticipating?

04:10Well, right now we are working with companies, and we're working on the proposed orders.

04:17We need to get the comments, finish the comments, and put them through.

04:20The sunscreen that is in, so this would be for a new sunscreen ingredient,

04:24we're working along with our timelines that we have in our commitment letter.

04:28The other, the new things under MUFA II would be really to sort of continue to grow the program

04:35in a way that fosters innovation by working, you know, providing other opportunities to interact

04:40with FDA and understand our expectations, provide more clarity and education on the GRACE standard,

04:46which I think is what you were saying.

04:47There may be some confusion about what our expectations are.

04:51We certainly don't want superfluous studies.

04:54We want studies that answer the question, and that's all that we need.

05:00And I'm interested, I believe this subcommittee would benefit from reviewing the study

05:05that was required in my previous OTC modernization legislation.

05:11So, you know, again, it's just, you brought up one of the issues out there.

05:15I know we've heard in this subcommittee for a good number of years, it's just like on sunscreen.

05:19And I'm sure it came up, some other members have already brought it up, but, you know,

05:23the Europeans, they always say are so much far ahead of us on this,

05:27and so we want the United States to lead.

05:29So I look forward to working with you, and I appreciate the chairman

05:34and for the work that is going to be done in this subcommittee.

05:38And I also just want to take a point of personal privilege

05:41and congratulate you on the gavel here in the health subcommittee.

'We Want The United States To Lead': Bob Latta Urges Sunscreen Improvements To Catch Up With Europe

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