Expert Spotlight: Michael Werner
Despite passage of the SIA, no new sunscreen ingredients have been approved in the US.
Former President Obama signed the Sunscreen Innovation Act (SIA) into law in late November 2014. The SIA was designed to speed the approval of new sunscreen ingredients and formulations, many of which have been available in Europe, Asia, and Latin America for years. The last over-the-counter sunscreen ingredient to be approved by FDA was in the 1990s. Since 2002, eight new sunscreen applications have been filed and are still awaiting final decisions. Michael Werner, Policy Advisor to the Public Access to SunScreens (PASS) Coalition and Partner at Holland & Knight LLP in Washington, DC where he serves as co-leader of Healthcare & Life Sciences Industry Team, discusses the hold up and what dermatologists can do to move things forward.
It’s been a while since President Obama signed the SIA. What gives?
“Since enactment of the SIA, the FDA has met the timelines required by the Act. However, still no new sunscreen ingredients have been approved. The FDA was required under SIA to issue proposed orders for the eight pending sunscreens and develop draft and final guidance for testing of sunscreen ingredients. Although all eight of the pending sunscreen ingredients have been used all over the globe for many years, FDA’s proposed orders required more testing for all, including one sunscreen ingredient that was already approved under a New Drug Application [Editor’s note: Ecamsule (Mexoryl)]. In November 2015, FDA issued draft guidance on sunscreen safety and effectiveness testing. FDA’s draft guidance received 12 sets of public comments from toxicologists, dermatologists, public health groups, and sunscreen manufacturers raising significant concerns regarding FDA’s approach. Two independent scientists—Dr. Ed Sargent and Dr. Jeff Travers—completed and published a peer-reviewed scientific paper identifying inconsistencies between FDA’s approach with current science and international testing standards in the Journal for Regulatory Toxicology. In November 2016, FDA finalized this guidance without addressing the significant concerns submitted in public comments. The FDA chose not to make any significant changes to their approach.”
What do European and other countries have ingredient-wise that we don’t?
“European and other countries have choices of more sunscreen filters than are available in the United States because these countries have approved sunscreens that are one or two generations more advanced than the United States. Starting in the 1970s, the United States focused on approving UVB filters to prevent sunburn. According to the latest science, UVA rays penetrate deeper and are the primary cause of premature skin aging. In Europe and other countries, they have access to more UVA filters, which allow for more broad spectrum sunscreens.”
What can and should dermatologists do to better advocate for their patients?
“Full implementation of the Sunscreen Innovation Act consistent with internationally accepted testing standards that ensures that Americans have access to the latest sunscreen technology is an important first step. Dermatologists that would like to see more broad spectrum sunscreens in the United States should call Congress to insist on full implementation of the Sunscreen Innovation Act by adopting an internationally accepted scientific approach in the evaluation of new sunscreen ingredients to ensure that Americans have access to the latest safe and effective sunscreen technology as soon as possible.”