Ahead of this Wednesday’s Senate Health, Education, Labor and Pensions (HELP) Committee markup of the bipartisan Sunscreen Innovation Act, I had the opportunity to interview Michael Werner who serves as the Policy Advisor for the the Public Access To SunScreens (PASS) Coalition . The coalition is the leading organization working to establish a regulatory pathway for timely pre-market review of new, safe and effective sunscreen ingredients. With 15 co-sponsors and expectations that the bill will advance through committee to the Senate floor, Michael provided an overview of what both consumers and the industry can expect in the coming months, along with insights into the importance of building strong coalitions.

Sheena: The coalition is made up of various health organizations, sunscreen ingredient companies, and citizens that have come together to advocate for the approval of the next generation of Over-The-Counter (OTC) sunscreens. How do you work with such a diverse group to determine strategy and goal setting?

Michael: There has been remarkable consensus since the Coalition’s inception about the seriousness of the public health problem posed by the flaws in the OTC/TEA process and the need for a comprehensive solution. The Coalition has met regularly for the past 18 months to maintain that consensus. Members of the Coalition have also met with Members of Congress, FDA, and other policy makers during that time.

Sheena: Why is it important to have such a diverse group of organizations apart of the coalition? Do Members of Congress see the coalition and its members as a positive component for passing meaningful legislation?

Michael: Diversity of membership is critical. It ensures that the policies the Coalition advocates are representative of the views of the entire sunscreen/skin cancer prevention community. It is essential for Congress and other policy makers to hear not only the concerns of manufacturers but also learn about the public health implications of current policy as articulated by public health and research groups. Therefore, the Coalition’s diversity ensures that Congress and policy makers get a comprehensive perspective of the problem and learn the importance of a comprehensive solution.

Sheena: The coalition had a recent success with the passage of the Sunscreen Innovation Act, H.R. 4250. What challenges lie ahead with passing the Senate companion bill, S. 2141? What plans does the coalition have for 2015?

Michael: The Coalition is confident that the Senate will pass the Sunscreen Innovation Act in September and the legislation will be enacted prior to Congressional adjournment this fall. Looking ahead to 2015, the Coalition will be working with Congress and FDA on implementation of the key provisions of the legislation.

Sheena: What advice would you give to independent and larger cosmetics companies that are hesitant to participate in advocacy efforts such as coalitions or lobbying activities with trade associations?

Michael: Each situation is different. But often when organizations can join forces they can be more effective than when they operate alone.


Michael Werner is a Partner at Holland & Knight with three decades of experience in healthcare law, lobbying, regulatory, and policy development in Washington. As the Policy Advisor for the  PASS Coalition he also service as the groups spokesperson. To learn more about the PASS Coalition visit their website at http://www.passcoalition.com

1938 is the online magazine blog for Well-Kept Beauty, formally entitled Primer.

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