Most OTC drugs, including nearly all sunscreen products, are marketed in  the United States by following the OTC monograph process. The sunscreen monograph currently includes 16 active ingredients. To be eligible for review under the TEA  process, the sponsor must submit an application showing that the active  ingredient has been marketed in OTC drugs for a material time and to a  material extent, as shown by, for example a minimum of 5 continuous years in the same country, or multiple  countries outside the United States, or in an OTC product with an  approved NDA in the United States; and a sufficient quantity as measured by the total number of dosage units  or weight of active ingredient sold, and in a population reasonably  extrapolated to the population of the United States. FDA Implemented SIA Requirements for Reviewing Applications for Sunscreen Active Ingredients within Mandated Time Frames

FDA implemented requirements for reviewing applications for sunscreen  active ingredients within the time frames required by SIA. FDA’s Review of Sunscreen Active Ingredient Applications Determined Additional Safety and Effectiveness Data Needed, and Most Took More than 8 Years

As of February 2015, FDA completed its review of the safety and  effectiveness data—that is, the initial GRASE determination—for each of  the eight sunscreen applications submitted between the creation of the  TEA process in 2002 and SIA’s enactment in 2014. For all eight pending sunscreen applications, FDA requested additional  safety and effectiveness data to support a GRASE determination. FDA’s 2016 guidance on safety and effectiveness data for sunscreen  states that its approach for evaluating the safety of sunscreen active  ingredients is based on the agency’s current scientific understanding of  topical products for chronic use. However, FDA  reports that the increase in the amount and frequency of sunscreen  usage, coupled with advances in scientific understanding and safety  evaluation methods, has changed the agency’s perspective on what it  needs to determine if sunscreen active ingredients are GRASE. Without the act, some  of them questioned whether FDA would have reviewed the sunscreen  applications or provided feedback to the sponsors. Sponsors Questioned FDA’s Request for Additional Safety and Effectiveness Data; No Additional Data Have Been Provided

Sponsor representatives and some stakeholders questioned the  additional safety and effectiveness data requested by FDA citing the  following reasons
Requested test not previously conducted on sunscreen. Some  of these sponsor representatives and stakeholders said there is a lack  of knowledge by sponsors and testing laboratories on how to conduct  this test, as well as a lack of testing protocols. Some stakeholders noted that sunscreen  active ingredients that are currently marketed are not subject to this  level of scrutiny. Some stakeholders supported FDA’s request that sponsors provide  additional safety and effectiveness data to determine if an active  ingredient is GRASE for use in sunscreens. According  to sponsor representatives we spoke with, the sponsors are either still  considering whether to conduct the additional tests FDA requested or  they do not plan to do so. The reasons cited by the sponsor  representatives and stakeholders included
Return on investment. Sponsor representatives said the testing FDA  requested is extensive, would cost millions of dollars, or take several  years to conduct. Alternatives not accepted. Some sponsor representatives and  stakeholders said that when alternative testing methods were  proposed to FDA in place of the MUsT and other tests recommended  by the agency, FDA rejected the alternatives. Animal testing. Some sponsor representatives and one stakeholder  mentioned concerns about conducting tests on animals, because of  the effect it may have on a company’s ability to market products  worldwide. Additionally, one sponsor and one stakeholder expressed concern  that sunscreen manufacturers may face backlash from animal rights  groups and shareholders if animal testing is conducted. Agency Comments

We provided a draft of this report to the Department of Health and Human  Services for review and comment. The department provided technical  comments, which we incorporated as appropriate. Appendix I: Steps the FDA Has Taken To Review Applications for Non-Sunscreen Active Ingredients

To examine the steps the Food and Drug Administration (FDA) has taken  to review time and extent (TEA) applications for non-sunscreen active  ingredients, we reviewed the Sunscreen Innovation Act (SIA), applicable  FDA regulations and guidance, and other relevant documentation  associated with the non-sunscreen TEAs. If FDA determines  that the application can be filed, the agency then has 2 years after the  filing date to issue a proposed order determining whether the ingredient is  generally recognized as safe and effective (GRASE). One non- sunscreen TEA that was submitted in 2004 to add an anti-dandruff  ingredient to the over-the-counter monograph was pending FDA  review as of August 2017.
Why GAO Did This Study

Using sunscreen as directed with other sun protective measures may help reduce the risk of skin cancer—the most common form of cancer in the United States. In the United States, sunscreen is considered an over-the-counter drug, which is a drug available to consumers without a prescription. Some sunscreen active ingredients not currently marketed in the United States have been available in products in other countries for more than a decade. Companies that manufacture some of these ingredients have sought to market them in the United States by applying to add the ingredients to the sunscreen monograph, which lists ingredients that can be used in sunscreens without FDA's premarket approval. FDA reviews the applications and corresponding safety and effectiveness data for the ingredients.
The Sunscreen Innovation Act includes a provision for GAO to examine FDA's implementation of the act. This report examines (1) the extent to which FDA implemented requirements for reviewing applications for sunscreen active ingredients within mandated time frames, and (2) the status of the sunscreen applications. GAO reviewed FDA regulations and guidance documents, Federal Register notices, and FDA and sponsor documents for all eight sunscreen applications. GAO also interviewed FDA officials; sponsors of sunscreen applications; and stakeholders with interests in sunscreen, including health care providers, researchers, and industry groups. Stakeholders were selected based on knowledge of the monograph process and sunscreen active ingredients. The perspectives of these stakeholders are not generalizable.

What GAO Found

The Food and Drug Administration (FDA), within the Department of Health and Human Services, implemented requirements for reviewing applications for sunscreen active ingredients within time frames set by the Sunscreen Innovation Act, which was enacted in November 2014. For example, the agency issued a guidance document on safety and effectiveness testing in November 2016.
As of August 2017, all applications for sunscreen active ingredients remain pending after the agency determined more safety and effectiveness data are needed. By February 2015, FDA completed its initial review of the safety and effectiveness data for each of the eight pending applications, as required by the act. FDA concluded that additional data are needed to determine that the ingredients are generally recognized as safe and effective (GRASE), which is needed so that products using the ingredients can subsequently be marketed in the United States without FDA's premarket approval. To make a GRASE determination, FDA requested that the application sponsors provide additional data, including human clinical studies, animal studies, and efficacy studies.
Sponsors of some of the sunscreen applications and some stakeholders GAO interviewed questioned FDA's requests, stating, for example, that the agency's recommended absorption test has never been conducted on sunscreen ingredients and there is a lack of knowledge on how to conduct it. At the same time, other stakeholders support the additional testing FDA requested. FDA reports that the increase in the amount and frequency of sunscreen usage, coupled with advances in scientific understanding and safety evaluation methods, has informed the agency's perspective that it needs additional data to determine that sunscreen active ingredients are GRASE. However, none of the sponsors reported current plans to provide the requested information—that is, they are either still considering whether to conduct the additional tests or they do not plan to do so. They cited the following reasons:
Return on investment. The testing FDA requested is extensive, would cost millions of dollars, or take several years to conduct, according to sponsor representatives. Some stakeholders and sponsor representatives said that sponsors are currently working to develop newer sunscreen ingredients and are therefore reluctant to invest in the testing FDA requested for the older ingredients covered by the pending applications.
Alternatives not accepted. Some sponsor representatives and stakeholders said that when they proposed alternative testing methods for absorption, for example, the agency rejected the alternatives.
Animal testing. One stakeholder and some sponsor representatives reported concerns about the effect that the animal testing requested by FDA may have on companies' marketing of sunscreen products worldwide. Additionally, one stakeholder and representatives from one sponsor expressed concern that sunscreen manufacturers may face backlash from animal rights groups and shareholders if animal testing is conducted.
The Department of Health and Human Services provided technical comments on a draft of this report, which GAO incorporated as appropriate.