From chemical sunscreen to the measles outbreak and drug approvals to product recalls, dermatology experienced its share of firsts and controversies in 2019.
Chemical Sunscreen Controversies
Controversial concerns about the effects of chemical sunscreen on coral reefs took an unprecedented turn in the United States this last year. On February 5, 2019, an ordinance was passed in Key West, Florida, prohibiting the sale of sunscreen containing the organic UV filters oxybenzone and/or octinoxate within city limits.1 On June 25, 2019, a similar law that also included octocrylene was passed in the US Virgin Islands.2 In so doing, these areas joined Hawaii, the Republic of Palau, and parts of Mexico in restricting chemical sunscreen sales.1 Although the Key West ordinance is set to take effect in January 2021, opponents, including dermatologists who believe it will discourage sunscreen use, currently are trying to overturn the ban.3 In the US Virgin Islands, part of the ban went into effect in September 2019, with the rest of the ban set to start in March 2020.2 Companies have started to follow suit. On August 1, 2019, CVS Pharmacy announced that, by the end of 2020, it will remove oxybenzone and octinoxate from some of its store-brand chemical sunscreens.4
On February 26, 2019, the US Food and Drug Administration (FDA) proposed that there are insufficient data to determine if 12 organic UV filters—including the aforementioned oxybenzone, octinoxate, and octocrylene—are generally recognized as safe and effective (GRASE).5 Although these ingredients were listed as GRASE by the FDA in 2011, the rise in sunscreen use since then, as well as changes in sunscreen formulations, prompted the FDA to ask manufacturers to perform additional studies on safety parameters such as systemic absorption.5,6 One study conducted by the FDA itself was published in May 2019 and showed that maximal use of 4 sunscreens resulted in systemic absorption of 4 organic UV filters above 0.5 ng/mL, the FDA’s threshold for requiring nonclinical toxicology assessment. The study authors concluded that “further studies [are needed] to determine the clinical significance of these findings. [But] These results do not indicate that individuals should refrain from the use of sunscreen.”7 Some in the industry have suggested it may take at least 5 years to generate all the data the FDA has requested.6
End of the New York City Measles Outbreak
On September 3, 2019, New York City’s largest measles outbreak in nearly 30 years was declared over. This announcement reflected the fact that 2 incubation periods for measles—42 days—had passed since the last measles patient was considered contagious. In total, there were 654 cases of measles and 52 associated hospitalizations, including 16 admissions to the intensive care unit. Most patients were younger than 18 years and unvaccinated.8
The outbreak began in October 2018 after Orthodox Jewish children from Brooklyn became infected while visiting Israel and imported the measles virus upon their return home.8,9 All 5 boroughs in New York City were ultimately affected, although 4 zip codes in Williamsburg, a neighborhood in Brooklyn with an undervaccinated Orthodox Jewish community, accounted for 72% of cases.8,10 As part of a $6 million effort to stop the outbreak, an emergency order was placed on these 4 zip codes, posing potential fines on people living or working there if they were unvaccinated.8 In addition, a bill was passed and signed into law in New York State that eliminated religious exemptions for immunizations.11 In collaboration with Jewish leaders, these efforts increased the administration of measles-mumps-rubella vaccines by 41% compared with the year before in Williamsburg and Borough Park, another heavily Orthodox Jewish neighborhood in Brooklyn.8
Drug Approvals for Pediatric Dermatology
On March 11, 2019, the IL-4/IL-13 inhibitor dupilumab became the third biologic with a pediatric dermatology indication when the FDA extended its approval to adolescents for the treatment of atopic dermatitis.12 The FDA approval was based on a randomized, double-blind, placebo-controlled trial in which 42% (34/82) of adolescents treated with dupilumab monotherapy every other week achieved 75% or more improvement in the Eczema Area and Severity Index at week 16 compared with 8% (7/85) in the placebo group (P<.001).13
In October 2019, trifarotene cream and minocycline foam were approved by the FDA for the treatment of acne in patients 9 years and older.14,15 As such, both became the first acne therapies to include patients as young as 9 years in their studies and indication—a milestone, considering the fact that children have historically been excluded from clinical trials.16 The 2 topical treatments also are noteworthy for being first in class: trifarotene cream is the only topical retinoid to selectively target the retinoic acid receptor γ and to have been studied specifically for both facial and truncal acne,14,17 and minocycline foam is the first topical tetracycline.15