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/

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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.


The Sunscreen Innovation Act Heads to the President’s Desk for Signature

(Washington, D.C.) — Today, the Public Access to SunScreens (PASS) Coalition applauds the House of Representatives for passing the Senate version of the Sunscreen Innovation Act (S.2141) by unanimous consent. The next stop for the legislation, introduced earlier this year, is the President’s desk for his signature.

"Today’s passage of the Sunscreen Innovation Act is the culmination of almost a years’ worth of hard work by Congress 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.

“Today’s passage brings us one step closer to a streamlined and transparent review process for innovative sunscreen ingredients,” said Wendy Selig, President & CEO of the Melanoma Research Alliance. “We are grateful for the collaborative effort to get this bipartisan bill passed, even at a time when achieving strong bipartisan action is challenging. This effort would not have been possible without the leadership of the Public Access to SunScreens (PASS) Coalition, a unique group comprised of both the nonprofit and for profit sectors.”

The PASS Coalition praises champions Representative Ed Whitfield (R-KY), Representative John Dingell (D-MI), Senator Jack Reed (D-RI) and Senator Johnny Isakson (R-GA), 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 Sunscreen Innovation Act 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.

Once signed by the President, the bipartisan Sunscreen Innovation Act (H.R. 4250/S. 2141) would streamline the approval process for new sunscreen ingredients to ensure that new sunscreen products receive a transparent review within a predictable timeframe.

The PASS Coalition looks forward to the Food and Drug Administration (FDA) implementing the new law and approving the eight pending sunscreen ingredients by the end of 2015. 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.

“Americans lack access to the latest sunscreen ingredients, which have been widely available in Europe, Asia, and Central and South America, in some cases for over 15 years. The Sunscreen Innovation Act will ensure FDA approves the latest sunscreens in a predictable timeframe, and enable future generations of sunscreen products to reach American consumers in a timely fashion,” Werner concluded.