Public Access to SunScreens Coalition Responds to Centers for Disease Control and Prevention's Call for Public Comments Regarding Skin Cancer Prevention in U.S.

PASS Coalition Calls on CDC to Urge FDA to Clear 10-Year Backlog in Sunscreen Applications
(Washington, DC) --The Public Access to SunScreens (PASS) Coalition this week submitted comments to the Centers for Disease Control and Prevention (CDC) in response to the CDC's request for public comments regarding efforts to help prevent skin cancer in the United States. The CDC's request made in the Federal Register can be seen here:
In its comments, PASS requests the CDC to "urge the FDA to clear the 10-year backlog in new sunscreen applications and create a predictable, transparent and timely review process for pre-market approval of new sunscreen ingredients."
PASS notes that "American consumers have limited choices when it comes to broad-spectrum sunscreen products. This is attributed to FDA's decade-long delay regarding eight new sunscreen ingredient applications. This sunscreen technology currently awaiting approval before FDA has been widely available in Europe, Asia, Central and South America, in some cases for over 15 years."
PASS continues by saying, "At a time when cases of skin cancer outnumber the occurrence of all other cancers, and one American dies every hour from melanoma, a lethal form of skin cancer, it is imperative for Americans to have access to the latest safe and effective sunscreen products available."
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 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 current membership of the PASS Coalition includes: the Melanoma Research Alliance, the Melanoma Research Foundation, the Prevent Cancer Foundation, The Skin Cancer Foundation, the Sun Safe Tee Program, Dr. Harry Fallick, Dr. Elizabeth Hale, Dr. Henry Lim, Dr. Warwick Morison, Dr. Nadim Shaath, Dr. Steven Wang, Ashland Inc., BASF Corp., Beiersdorf, DeWolf Chemical, Inc, Fitz Chem Corporation, L’Oréal USA Products, Inc, McCullough & Associates, Proctor & Gamble and the Suncare Research Laboratories.
PASS Coalition's full comments can be accessed here:!documentDetail;D=CDC-2013-0014-1013

Public Health Advocates Seeing Red Over Delay in Sunscreen Products

Published in The Hill
By Julian Hattem

Public health advocates are seeing red over the federal government’s failure to approve new ingredients for sunscreen.

The Food and Drug Administration (FDA) has spent more than a decade reviewing sunscreen products that have long been on store shelves in Europe, Canada, Mexico and other countries.

The delay has gone on long enough, say lawmakers, skincare companies and public health organizations who want to do something about the 3.5 million Americans who are diagnosed with skin cancer every year.

“The fact that we have things on the market in other developed countries for over a decade that are not available here just doesn’t make any sense,” said Tim Turnham, executive director of the Melanoma Research Foundation.

Applications to approve three new sunscreen chemicals have been sitting at the FDA since 2002 with no response. Five more have since been added to the list.

The applications have been tied up in an arcane FDA process for reviewing products that have been on the market “to a material extent and for a material time” in other countries. That process, known as the Time and Extent Application (TEA), is broken, according to advocates who want the new sunscreen ingredients approved.

FDA spokeswoman Andrea Fischer told The Hill in an email that the agency is “working diligently to evaluate the submitted data” according to current standards.

Fischer added that the FDA was “also investigating ways, consistent with existing regulations, to inform stakeholders in a more expedited fashion on the status of TEAs that are currently being evaluated.”

Supporters of the new sunscreen ingredients aren’t satisfied with that response.

Wendy Selig, head of the Melanoma Research Alliance, compared the delay to a halt for a new cancer treatment.

“If we’re basically saying what’s out there now is what we knew about 10 years ago, think about what we knew on the treatment side. That would be ridiculous, right?” she said.

FDA approval would allow sunscreen manufacturers to make a wider variety of products. The new formulations might be appealing to people who don’t currently use sunscreen, industry officials told The Hill, and get more people to protect themselves from ultraviolet rays.

The delay is also discouraging skincare companies from even trying to develop new products for the U.S. market.

“There are other fillers that have been developed and launched within the past decade that haven’t even been submitted because the backlog has not been cleared out yet,” said Al Pearce, a senior marketing manager at the BASF skincare company.

The health and skincare groups are part of a coalition that has been launched to pressure the FDA to act on the submissions.

But they’re not alone, as lawmakers in Congress have also taken notice of the delays.

In recent weeks, nine legislators including Sens. Jack Reed (D-R.I.), Dianne Feinstein (D-Calif.) and Chuck Schumer (D-N.Y.) sent a letter to FDA Commissioner Margaret Hamburg calling it “critical" that sunscreens “contain ingredients that offer the strongest possible protection from the sun.”

Reed has been working with Sen. Johnny Isakson (R-Ga.), to “explore possible ways to improve this process so that new sunscreens with demonstrated safety and effectiveness can come to the market," according to a statement to The Hill from Isakson spokeswoman Lauren Culbertson.

She added that Isakson was “very troubled by the lengthy delays“ in approving the applications. “As a skin cancer survivor, Sen. Isakson believes it is important for Americans to have access to the best sunscreen products,” she said.

In the House, the annual agriculture appropriations bill under consideration instructs the FDA to finish its review of the sunscreen ingredients by next June.

The legislation also requires the FDA to work with Congress, cancer groups and manufacturers “to develop a new process that will allow safe and effective sunscreen ingredient market applications to receive a final decision from FDA within one year of application date.”

In a letter to Rep. John Dingell (D-Mich.) earlier this month, FDA Deputy Commissioner for Policy, Planning and Legislation Sally Howard wrote that a proposed rule on three of the sunscreen ingredients is expected in September.

But that’s little comfort to the coalition looking for the ingredients to be approved.

“I wouldn’t say that we’re cynical and skeptical, except there is a little bit of wait-and-see attitude,” said Turnham, “except not very much interest in waiting very long.”