From the U.S. Government Accountability Office, www.gao.gov Transcript for: Sunscreen Innovation Description: Some of the sunscreens Europeans have been applying for years can't be found in the U.S. So, where's the rub? We took a look at the Sunscreen Innovation Act. Related GAO Work: GAO-18-61: Sunscreen: FDA Reviewed Applications for New Active Ingredients and Determined More Data Needed Released: November 2017 [ Background Music ] [ Marcia Crosse: ] Because they are recommended to be applied frequently, in larger volumes, over large portions of your body, and including on children, they want to be sure that they're safe and effective. [ Background Music ] [ Jacques Arsenault: ] Welcome to GAO's Watchdog Report, your source for news and information from the U.S. Government Accountability Office. I'm Jacques Arsenault. Using sunscreen may help reduce the risk of skin cancer, the most common form of cancer in the United States. Yet, some of the sunscreens that Europeans have been applying for years can't be found in the U.S. So you may ask, "Where's the rub?" I sat down with Marcia Crosse, a director in our Health Care team, to find out more about GAO's new report that takes a look at the Sunscreen Innovation Act and how the FDA determines whether a sunscreen ingredient is safe and effective. I wanted to know, "What's the advantage of sunscreen ingredients that are used in Europe but can't be found in the U.S.?" [ Marcia Crosse: ] Well, first, I have to say that we don't actually know if those ingredients are any better, but there are more ingredients and more choices for consumers in what's available in Europe. And in part that's because the European process is one that's more akin to things like cosmetics whereas in the United States sunscreens are regulated as over-the-counter drug products because of the health claims that they make for things like helping to prevent skin cancer. [ Jacques Arsenault: ] So it would be more akin to something like Tylenol than hand lotion. [ Marcia Crosse: ] Yes. [ Jacques Arsenault: ] So then how difficult is it to bring a new sunscreen ingredient into the U.S. market? [ Marcia Crosse: ] Well, there is a regular process where you have to be sure the FDA has the information it needs to modify what's called the monograph, which is like a recipe book for the active ingredient that can be used in an over-the-counter product like this. And it's -- it's been difficult because FDA has said they haven't had the necessary resources and they've been taking a long time to actually review the applications that were submitted. In some cases, they took more than 8 years to get back with an answer to a sponsor. And the answer was not an approval of their sunscreen; the answer was we need more information. [ Jacques Arsenault: ] So you would submit an application and 8 years later FDA would come back and say this is not quite enough for us to make a final decision or to approve. [ Marcia Crosse: ] Yes, in some cases that's exactly what happened. And in part because of the lengthy periods of time, the Sunscreen Innovation Act that was enacted in 2014 actually set deadlines for FDA to make a decision and FDA has since that time met those deadlines, but their decision has been "we need more information." [ Background Music ] [ Jacques Arsenault: ] The way we thought about sunscreen in the U.S. certainly seems to have changed over the years, and I know it's a much bigger deal now as a father of two boys than it was when I was a kid myself. I asked Marcia to tell me whether FDA has grown more concerned in recent years about what's in sunscreen products and has that approval process changed. [ Marcia Crosse: ] Yes, well, that's actually part of what's going on here. FDA officials have become aware of that change in how sunscreens are used. And because they are recommended to be applied frequently, in larger volumes, over large portions of your body, and including on children, they want to be sure that they're safe and effective. And there's a better understanding now that lotions and other things like this that are creams that are applied on your skin can be absorbed through the skin and FDA wants information on what the long-term effects of that and the higher doses that are now being used, what that might mean for people who use these products for years and years. [ Jacques Arsenault: ] So it seems then that there's this greater recognition or awareness or move toward using sunscreen, and so on one hand that may increase the pressures for companies to offer more products, but at the same time it increases the scrutiny that FDA is looking to put on what they allow. [ Marcia Crosse: ] Yes, exactly. And so I think that's part of what's led us to this current situation where there's a bit of an impasse where FDA wants more information and the drug sponsors aren't sure that the investment that it would take to get that information is worth it to them. [ Jacques Arsenault: ] Can you explain a little bit more about that? [ Marcia Crosse: ] Well, the way that these ingredients work, as I said, there's something like a recipe book, the monograph, and it's for the active ingredient, and different manufacturers can buy that same active ingredient. And so for one manufacturer to undertake all of the work to do the studies and maybe to do clinical trials or other kinds of studies for a long period of time, you know, months with different individuals, it may not be worth it to them if then another manufacturer can just come along after them and use that same ingredient once it's approved. And so whether that investment when they don't have exclusive control is worth it to the company, that's something that they have to make a business decision about and right now we're at a bit of an impasse. [ Jacques Arsenault: ] So finally then, what would you say is the bottom line of this report? [ Marcia Crosse: ] I think that the bottom line is that it's still important for people to be using sunscreens to protect against skin cancer, but, you know, we are in a bit of a dilemma where industry and the regulators are not in agreement about what's necessary in order for us to move forward in this area. And so I think the bottom line is stay tuned because there may be more products coming to the market, but not yet. [ Background Music ] [ Jacques Arsenault: ] Thanks for listening to the Watchdog Report. To hear more podcasts, subscribe to us on Apple Podcasts. [ Background Music ] [ Jacques Arsenault: ] For more from the Congressional watchdog, the U.S. Government Accountability Office, visit us at gao.gov.