The PASS Coalition stands for the Public Access to SunScreens Coalition. The PASS Coalition is a multi-stakeholder coalition of public health organizations, dermatologists, sunscreen ingredient companies and concerned citizens who will work collaboratively with the Food and Drug Administration (FDA), the White House and Congress to establish a timely and transparent framework for approval of the next generation of UV active filters for Over-the-Counter (OTC) sunscreens.
The FDA regulates sunscreens as OTC drugs in the United States. A new sunscreen ingredient must be approved by the FDA before it is available for sale in the United States.
In January 2002, the FDA created the “time and extent application” (TEA) process to address gaps in the approval processes for new OTC products not covered by the New Drug Applications (NDAs) or the existing OTC monographs. TEAs attempted to provide an approval route for OTC drugs whose safety and efficacy could be reviewed and determined based on a minimum of five continuous years of safe use. The final rule set forth a streamlined approval process in which the FDA will “strive to complete TEA evaluations in 90 to 180 days.” In 2002, FDA estimated that it would approve 30 TEA applications per year.
Unfortunately, the TEA process is broken. The FDA has not approved a single sunscreen ingredient through the TEA process since the creation of the program in 2002. Eight OTC sunscreen ingredients have been submitted to the FDA for review and approval. The FDA has not completed a review of ANY of these applications.
- Amiloxate (2002)
- Enzacamene (2002)
- Octyl Triazone (2002)
- Bemotrizinol (2005)
- Bisoctrizole (2005)
- Iscotrizinol (2005)
- Ecamsule (2007)
- Drometrizole Trisiloxane (2009)
Approvals the above active ingredients have been on hold for over a decade in some cases — and at the expense of enhanced safety for American consumers. The UV filters Bisoctrizole and Bemotrizinol, for example, have been widely used in Europe and other countries since 2000 and have proven to provide broad-spectrum formulations for more efficacious products. Other safe ingredients such as Ecamsule and Drometrizole Trisiloxane have also been commercially available around the world in various broad-spectrum topical formulations including creams, lotions, spays and sticks since the 1990s.
Over the past decade, the FDA has struggled to review pending applications for OTC sunscreen ingredients. The current pre-market review process needs to be reformed to ensure timely review and add transparency and predictability. While the agency has stated it is committed to completing consideration of pending sunscreen applications, it has indicated that regulatory delays and a lack of resources currently stand in the way. This is unacceptable.
The mission of the PASS Coalition is to work to establish a regulatory pathway for timely pre-market review of new, safe and effective sunscreen ingredients. The Coalition is considering a variety of reform solutions that will ensure a predictable and transparent review of sunscreen ingredient applications.
One possible solution is for Congress to pass legislation that will reform the current FDA sunscreen ingredient review process and ensure all sunscreens receive a transparent review within a predictable timeframe. This reformed process should include an expedited review of the backlog of sunscreen applications and establish a new process that allows future sunscreen ingredient applications to receive a decision within one year of submission.
A reformed sunscreen ingredient review process would benefit the American public because:
- Consumers would gain more rapid access to the safest and most effective sunscreens.
- New active ingredients would receive a thorough review for effectiveness within a predictable timeframe.
Regardless of the mechanism used to expedite the review of OTC sunscreen ingredients, it is clear that we cannot wait any longer for action. The current system is broken and Congress must act now to fix it.
A U.S. National poll conducted February 4 - 8, 2013 found that 86 percent of Americans support a program that allows for better sunscreen products (margin of error of +/- 3.1%).
Contact your Member of Congress and urge them to support establishing a timely approval process for sunscreen products at the FDA. To find out who your Member of Congress is, please visit the following websites:
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