April 20, 2018 – PASS Coalition Supports the Senate’s Legislation to Modernize the FDA’s Process for Considering New OTC Ingredients, Including New and Pending Sunscreen Ingredients

The Honorable Lamar Alexander
United States Senate
Washington, DC 20510

The Honorable Patty Murray
United States Senate
Washington, DC 20510

The Honorable Johnny Isakson
United States Senate
Washington, DC 20510

The Honorable Bob Casey
United States Senate
Washington, DC 20510


Dear Chairman Alexander, Ranking Member Murray, Senator Isakson and Senator Casey,

On behalf of the Public Access to SunScreens (PASS) Coalition, I am writing in strong support of the Over-the-Counter Drug Safety, Innovation, and Reform Act (S. 2315). The PASS Coalition is a multi-stakeholder coalition composed of public health groups, dermatologists, sunscreen manufacturers, and leading advocates for skin cancer patients. This legislation creates important reforms to the over-the-counter (OTC) drug review process at the Food and Drug Administration (FDA) to ensure that FDA has the resources and reforms necessary to review OTC drugs, including safe and effective sunscreen ingredients, and make final decisions in a timely manner in order to protect the health of all Americans.

According to the U.S. Surgeon General, over 5 million Americans are treated for skin cancer every year, costing American taxpayers $8.1 billion annually. Based on the skin cancer epidemic in the U.S., Americans should have access to the latest safe and effective sunscreen ingredients, especially sunscreens that have a history of safe and effective use in Europe for over 20 years in some cases.

As a result, Congress unanimously enacted the Sunscreen Innovation Act (SIA) in November 2014 to reform the OTC review process for sunscreen ingredients and set timelines for the review of pending sunscreen ingredients, many of which had been pending for over a decade. Without the critical reforms in the SIA and in S. 2315, there is no clear pathway under the current system for approval of new ingredients not already part of an existing monograph.

S. 2315 represents a strong, bipartisan collaboration between Congress, FDA, public health stakeholders, and industry that will significantly reform the FDA’s OTC review process. In particular, the PASS Coalition strongly supports Section 103(c) in S. 2315 that would provide two years of product differentiation for pending sunscreen ingredients to account for the regulatory delay of over a decade in reviewing these sunscreen ingredients. Because of this delay, many of the sunscreen ingredients pending approval have or soon will lose their patent life and other market protections, putting their entrance into the U.S. market in doubt at the expense of patients. A two-year period of product differentiation would help mitigate this concern.

The legislation also includes provisions that hold the promise of making new sunscreens available, including:

  • Section 505G establishes a user fee program that will establish a more transparent and timely review for new OTC drug applications;
  • Section 505G(c)(6)(D)(i)(II) provides flexibility to the FDA to determine when to request a new drug application from sponsors; and
  • Section 103(b) allows sunscreen sponsors to have individual meetings with FDA to discuss confidential data requirements and testing protocols.

These reforms provide significant benefit to FDA, the regulated community, and the public health of all Americans.

We look forward to working with the Committee on Section 505G(c)(6)(D)(iii)(II)(aa) to provide some additional certainty on the length of time a product in a comparable jurisdiction must establish a history of safe and effective use before it is eligible to apply through the user fee system to receive a FDA review for safety and effectiveness.

The PASS Coalition thanks you for your work on this important issue to ensure that patients and their families have access to safe and effective sunscreen products. Should you have any questions, please contact me at michael.werner@hklaw.com.




Michael Werner
Public Access to SunScreens Coalition

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