February 22, 2016
Kristen Hardin
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 22, Rm. 5443 Silver Spring, MD 20993-0002
RE: Public Comments on Draft Guidance “Over-the-Counter Sunscreens: Safety and Effectiveness Data Draft Guidance for Industry” [Docket No. FDA-2015-D-4021]
Dear Ms. Hardin,
The following are the comments of the Public Access to SunScreens (PASS) Coalition, on the draft guidance entitled “Over-the-Counter Sunscreens: Safety and Effectiveness Data Draft Guidance for Industry” (the Guidance) published in the Federal Register on November 23, 2015, as required by the Sunscreen Innovation Act (Public Law 113-195). As a result of President Obama’s announcement of an Administration-wide initiative led by Vice President Biden to prevent and cure cancer at his last State of the Union address, making sure we get the final Guidance right is critical to ensure that Americans have access to the latest sunscreen technology to prevent skin cancer, the most common form of cancer in the United States.
General Comments
Background on the PASS Coalition
The PASS Coalition is a multi-stakeholder coalition comprised of public health groups, leading dermatologists, sunscreen manufacturers, and concerned citizens. Our membership includes the leading advocates for skin cancer patients. The PASS Coalition formed to ensure Americans have access to the latest sunscreen technology to curb the skin cancer epidemic in the United States. The Coalition’s mission is to work collaboratively with the FDA, the White House, Congress, health providers, consumer organizations and sunscreen manufacturers to establish a transparent review within a predictable timeframe for pending time and extent applications (TEAs) for over-the-counter (OTC) sunscreen ingredients. This comment letter represents the consensus view of the PASS Coalition, but does not necessarily indicate the view of each individual member.
A Moonshot to Prevent and Cure Cancer
Not long after his son died of cancer, Vice President Biden began calling for a “moon shot” to prevent and cure this disease. Addressing the prevention and cure of cancer became an official Administration priority when President Obama announced a new initiative lead by Vice President Biden to develop a strategy and lead this moon shot effort at his final State of the Union address before Congress. It is expected that the President will issue an executive order directing all federal agencies and departments to coordinate with the Vice President as a part of this cause.
One of the best ways to survive cancer is to prevent it in the first place. Since skin cancer is the most common cancer in the United States, ensuring that Americans have access to the latest skin cancer prevention technology should be a part of the moon shot initiative. This Guidance is critical to determining whether there will be a viable pathway for new skin cancer prevention technology to enter the US marketplace.
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