PASS Coalition Submits Comments in Response to FDA's Draft Guidance on OTC Sunscreens' Safety and Effectiveness

For Immediate Release: February 22, 2016

Contact: Aimee Steel Lubin, This email address is being protected from spambots. You need JavaScript enabled to view it. / 202-828-1895

(Washington, D.C.) — The Public Access to SunScreens (PASS) Coalition submitted comments in response to the FDA's Draft Guidance “Over-the-Counter Sunscreens: Safety and Effectiveness Data Draft Guidance for Industry” (the Guidance) published in the Federal Register on November 23, 2015, as required by the Sunscreen Innovation Act (Public Law 113-195).

The Act required FDA to issue draft and final guidance on the safety and effectiveness data to be used in the agency's review of new sunscreen ingredients. The final guidance is required under the Act by November 26, 2016. The following is a brief excerpt of the Coalition's comments:

 

The PASS Coalition appreciates that the FDA has issued this guidance and is attempting to balance benefit and risk when determining the appropriate safety and effectiveness data manufacturers must provide. Nonetheless, in our view the approach proposed falls short. By calling for manufacturers to complete new tests prior to marketing – including tests never before used on sunscreen ingredients, tests required by no other countries and for which there is no agreed-upon protocol – the FDA’s proposal may simply continue to deny Americans access to the latest skin cancer prevention products available throughout the rest of the world.

 

The PASS Coalition remains willing to work collaboratively with the FDA to develop and appropriate testing regime for new sunscreen ingredients - that will ensure safety while balancing the need for new and effective sunscreens to combat the ever-increasing risk of cancer.

 

"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. Since skin cancer is the most common form of cancer in the United States, removing the red tape for new broad spectrum sunscreens would be a moonshot victory for the 5 million Americans that will be diagnosed with the disease this year," said Michael Werner, PASS Coalition Policy Advisor

When the bipartisan Sunscreen Innovation Act was signed into law in 2014, Americans expected that they would soon be able to get the latest in sunscreen technology long available to citizens of countries all over the world. But well over a year has gone by and the FDA still has not approved these sunscreens despite their track record of safety and effectiveness,” Werner concluded. "The PASS Coalition looks forward to working with the FDA in an effort to get the latest in sunscreen technology in the hands of consumers, thus helping to reduce the risk of melanoma.”

Skin cancer is the most common form of cancer diagnosed in the U.S. Each year there are more new cases of skin cancer — including melanoma — than the combined incidence of breast cancer, prostate cancer, lung cancer and colon cancer.  From 1975-2011, rates of melanoma in young men and women ages 20-39 years increased by 34% in men and by 84% in women.

According to the Surgeon General, nearly 5 million Americans are diagnosed with skin cancer and one person dies every hour of every day from melanoma, the deadliest skin cancer.  The cost to treat skin cancer is over $8 billion, which doesn’t include the pain and suffering for families that lose their loved ones from the disease.  The Surgeon General and CDC both regularly call on Americans to wear sunscreen to prevent skin cancer.

The bipartisan Sunscreen Innovation Act (Public Law No: 113-195) streamlined the approval process for new sunscreen ingredients to ensure that new sunscreen ingredients receive a transparent review within a predictable timeframe. The law was intended to ensure the American public gains access to the latest safe, effective and innovative sunscreen products to protect against the sun’s most harmful rays.

The last over-the-counter (OTC) sunscreen ingredient to be approved by FDA was in the 1990s. Since 2002, eight new sunscreen applications have been filed and are still awaiting final decisions 13 years later. New sunscreen technologies currently awaiting approval in the U.S. have been widely available in Europe, Asia, and Central and South America, in some cases for more than 15 years.

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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 OTC sunscreens. Click here to see the full membership of the PASS Coalition.


PASS Coalition Commends Dr. Robert Califf for His Commitment to Work to Ensure New Sunscreens Get to Market

 On the Brink of Year Anniversary of the Sunscreen Innovation Act Becoming Law,
Nothing Has Changed Except Rising Melanoma Rates

 

(Washington, D.C.) —The Public Access to SunScreens (PASS) Coalition today commended Dr. Robert Califf on his public commitment to work with Senator Johnny Isakson (R-GA), other congressional leaders, and stakeholders to ensure new sunscreens are available in the U.S. in a reasonable timeframe as laid out by the Sunscreen Innovation Act signed into law in 2014. Dr. Califf expressed these comments today during his confirmation hearing for Commissioner of the Food and Drug Administration, (FDA).

“We are pleased that, in response to a question from Senator Isakson during his confirmation hearing, Dr. Califf expressed his commitment to working together with patient groups, cancer groups, and other stakeholders to bring new sunscreen ingredients to the U.S. market,” said Michael Werner, PASS Coalition Policy Advisor. “Senator Isakson, a melanoma survivor himself, rightly pointed out that on November 26th, it will be a year since the Sunscreen Innovation Act became law and still the FDA not reached an agreement with stakeholders on an appropriate approval standard for new sunscreen ingredients in spite of increased U.S. melanoma rates. Dr. Califf, who also has a family history of melanoma, acknowledged that we have to do better at preventing melanoma.”

“Americans have gone more than a decade without the kinds of innovative sunscreen products citizens in other countries have enjoyed for years. Meanwhile, skin cancer has become a public health crisis that is only getting worse according to the U.S. Surgeon General and Centers for Disease Control," said Werner.

“When the bipartisan Sunscreen Innovation Act was signed into law last year, Americans expected that they would soon be able to get the latest in sunscreen technology long available to citizens of countries all over the world. But almost one year has gone by and the FDA still has not approved these sunscreens despite their track record of safety and effectiveness,” Werner concluded. “We are hopeful that when confirmed, Dr. Califf will work with Senator Isakson and stakeholders to get these new ingredients to market in the near future.”

Skin cancer is the most common form of cancer diagnosed in the U.S. Each year there are more new cases of skin cancer — including melanoma — than the combined incidence of breast cancer, prostate cancer, lung cancer and colon cancer.  From 1975-2011, rates of melanoma in young men and women ages 20-39 years increased by 34% in men and by 84% in women.  According to the Surgeon General, nearly 5 million Americans are diagnosed with skin cancer and one person dies every hour of every day from melanoma, the deadliest skin cancer.  The cost to treat skin cancer is over $8 billion, which doesn’t include the pain and suffering for families that lose their loved ones from the disease.  The Surgeon General and  CDC both regularly call on Americans to wear sunscreen to prevent skin cancer.

The bipartisan Sunscreen Innovation Act (Public Law No: 113-195) streamlined the approval process for new sunscreen ingredients to ensure that new sunscreen ingredients receive a transparent review within a predictable timeframe. The law was intended to ensure the American public gains access to the latest safe, effective and innovative sunscreen products to protect against the sun’s most harmful rays.

The last over-the-counter (OTC) sunscreen ingredient to be approved by FDA was in the 1990s. Since 2002, eight new sunscreen applications have been filed and are still awaiting final decisions 13 years later. New sunscreen technologies currently awaiting approval in the U.S. have been widely available in Europe, Asia, and Central and South America, in some cases for more than 15 years.

PASS Coalition website: http://www.passcoalition.com/

PASS Coalition Facebook page: https://www.facebook.com/PASSCoalition?ref=hl

PASS Coalition Twitter page: https://twitter.com/PASSCoalition

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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 OTC sunscreens. Click here to see the full membership of the PASS Coalition.


FDA’s Announcement on Ecamsule and Enzacamene Applications Demonstrates Clear Disregard for Increased Rates of Melanoma, Public’s Demand for Latest Sunscreen Technology.

Like the Six previously Pending Ingredients

Ecamsule and Enzacamene Will Continue to be Held Hostage by the FDA

Today, the Public Access to SunScreens (PASS) Coalition released a statement regarding FDA’s recent announcement of two sunscreen ingredient applications, ecamsule and enzacamene.

Michael Werner, policy advisor to the PASS Coalition stated, “Today’s action taken by the FDA regarding ecamsule and enzacamene means that Americans will not have access to innovative products that have been used safely all over the world– in some cases for more than a decade. With skin cancer and melanoma rates increasing dramatically, Americans need more options to protect themselves from the sun’s harmful UV rays. Last fall, the US Surgeon General issued a Call to Action on skin cancer urging the federal government to work with the private sector and take necessary steps to respond to this public health crisis. FDA’s latest action is inconsistent with this approach.

Werner stated, “Ecamsule is unique among pending sunscreen ingredients because it has already been approved by FDA through the New Drug Application (NDA) process since 2006. The application was submitted for approval under the Time and Extent Application (TEA) for broader use in the OTC space, but prior to today, and despite its approval as an NDA, the application languished for almost 8 years at FDA without a decision. Like with the other products FDA has not approved under the TEA process, the agency’s message today is that manufacturers must submit data through a process with requirements that mimic the NDA process. This is not tenable for sunscreen and will result in delayed access to new products for Americans.”

Werner concluded, “Last year, Congress unanimously enacted the Sunscreen Innovation Act to get these products to the market quickly and respond to the public health crisis from growing rates of skin cancer and melanoma. We look forward to working Members of Congress and FDA to ensure the legislation is implemented to achieve that objective.”


The Sunscreen Innovation Act Signed By President Obama

(Washington, D.C.) —The Public Access to SunScreens (PASS) Coalition applauds President Barack Obama for signing the Sunscreen Innovation Act (S.2141). The PASS Coalition looks forward to working with the Congress and the Food and Drug Administration (FDA) to ensure the new law is implemented quickly and the 12-year sunscreen backlog is cleared so that Americans have access to the latest sunscreen ingredients by the summer of 2015.
 
"The signing of the Sunscreen Innovation Act by President Barack Obama is the culmination of persistent, bipartisan work by Congress and stakeholders to provide Americans with access to the latest sunscreen products to help curb future cases of skin cancer, particularly melanoma," said Michael Werner, PASS Coalition Policy Advisor.
 
The PASS Coalition thanks Congressional champions Representative Ed Whitfield (R-KY), Representative John Dingell (D-MI), Senator Jack Reed (D-RI) and Senator Johnny Isakson (R-GA), the full House Energy & Commerce Committee, the full Senate HELP Committee, as well as House Speaker John Boehner (R-OH), House Democratic Leader Nancy Pelosi (D-CA), Senate Majority Leader Harry Reid (D-NV) and Senate Republican Leader Mitch McConnell (R-KY) for their persistent work on this issue and enacting the Sunscreen Innovation Act during the Lame Duck session of Congress.
 
“We are confident that the new law will enable Americans to have greater choice when it comes to protecting their skin from the sun’s harmful UVA and UVB rays,” Werner said.
 
Skin cancer is the most common form of cancer diagnosed in the U.S. Each year there are more new cases of skin cancer — including melanoma — than the combined incidence of breast cancer, prostate cancer, lung cancer and colon cancer.  On average, one person dies every hour from melanoma, the deadliest of the skin cancers because of its ability to move quickly and spread to distant organs in the body, and melanoma rates are rising dramatically across demographics. Over the past 40 years, melanoma rates have increased 800 percent among young women and 400 percent among young men.
 
The last over-the-counter (OTC) sunscreen ingredient to be approved by FDA was in the 1990s. Since 2002, eight new sunscreen applications have been filed and are still awaiting review 12 years later.
 
With President Obama’s approval of the bipartisan Sunscreen Innovation Act, FDA must now work with applicants, Congress and stakeholders to implement the new law.  FDA must render a decision on the eight pending sunscreen application according to statutory timelines created by the legislation, with some decisions expected as quickly as six months from enactment.  
 
“The President’s approval of the Sunscreen Innovation Act demonstrates that the White House and Congress agree that FDA should ensure all sunscreens receive a transparent review within a predictable timeframe.  With this law, Congress has helped answer the U.S. Surgeon General's Call to Action to Prevent Skin Cancer.  The PASS Coalition and other stakeholders will now focus on working with FDA to guarantee the new law is implemented as quickly as possible,”  Werner concluded.
 
The PASS Coalition, public health groups, leading dermatologists, sunscreen ingredient manufacturers, key opinion leaders, skin cancer advocates, and the Congress will work together to ensure FDA is held accountable and meets the timeline requirements under the Sunscreen Innovation Act.