Sunscreen and the FDA

Correspondence
Sunscreen and the FDA

N Engl J Med 2015; 373:197July 9, 2015DOI: 10.1056/NEJMc1507737


Elsewhere in this issue of the Journal, Sharfstein reviews issues related to sunscreen products and the review process for products intended to be sold over the counter.1 The Food and Drug Administration (FDA) is dedicated to the prevention and treatment of skin cancer, which is a growing public health problem, particularly for children. Recent breakthroughs in the treatment of advanced melanoma have benefitted from new approaches to cancer-drug development and the design of clinical trials,2,3 as well as from the FDA's priority-review and accelerated-approval pathways.4

The prevention of skin cancer remains challenging and requires contributions from all sectors, including patients and advocates, industry, the clinical and academic communities, and government agencies, including the FDA. Key preventive approaches include avoiding direct exposure to the sun and other sources of ultraviolet radiation when possible, wearing protective clothing, and applying sunscreen.

As Sharfstein has reviewed in detail, the use of sunscreen as a measure to prevent skin cancer requires it to be regulated as a drug in the United States, and it has been deemed suitable for over-the-counter status. As with all drugs, our primary concerns are that marketed sunscreen products should be safe and effective for their intended uses and have a positive balance of benefit and risk; these findings should be supported by high-quality data.

To assess the current state of knowledge concerning sunscreens, the FDA recently convened an independent Nonprescription Drugs Advisory Committee5 that assessed the research and associated data needed to ensure the safety of sunscreen ingredients. One particular focus of concern for the committee was the need for studies of systemic absorption of the chemicals in sunscreen products, especially when these products are used in children, who have a high ratio of body-surface area to weight.

We applaud the efforts of Congress to promote innovation in sunscreen products. The Sunscreen Innovation Act continues to require the use of the monograph system (www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ucm317137.htm), a complex, iterative process that includes public vetting and incorporates the “generally recognized as safe and effective” standard, as described by Sharfstein.

Although this process has been streamlined by Congress specifically for sunscreens, the standards for demonstrating the efficacy and safety of those products remain the same. We have made a recommendation to sponsors regarding a pathway that will expedite completion of the studies needed to ensure that these products are safe and effective.

A renewed commitment to collaboration by industry, patients, clinicians, and academic researchers, with the goal of enabling the creation of robust evidence from high-quality clinical studies, could lead to the kind of breakthroughs in prevention that mirror the dramatic advances recently seen in the treatment of melanoma.

Robert M. Califf, M.D.
Stephen Ostroff, M.D.
Food and Drug Administration, Silver Spring, MD
robert.califf@fda.hhs.gov