Light Finally Shining on FDA’s Approval Delays of Next-Generation Sunscreen Products

sunshineGuest Commentary

by Samantha J. Malnar, a 2014 Judge K.K. Legett Fellow at the Washington Legal Foundation and a student at Texas Tech School of Law.

A “call to action” this week from the Surgeon General of the United States reports that nearly 5 million people are treated with skin cancer in America each year. Of those treated yearly, 9,000 die from melanoma. The report explains that skin cancer is the most preventable form of cancer, and urges steps government and individuals can take to reduce the risks. Regretfully, the Surgeon General failed to spotlight the role government regulation has played in increasing the risk of skin cancer. Thanks to federal regulators’ unconscionably slow action on reviewing and approving new formulas, Americans can only get the best available sunscreens overseas.

It has been fifteen years since the Food and Drug Administration (FDA) has approved a new sunscreen ingredient, even though there are eight applications pending—some dating back to 2002. Notably, the last application was submitted in 2009, which suggests that the agency’s failure to act has deterred companies from investing in the United States market. As the former head of the American Academy of Dermatologists told The Washington Post, “These sunscreens are being used by tens of millions of people every weekend in Europe, and we’re not seeing anything bad happening.” In fact, in European countries, sunscreen manufacturers can choose from twenty-seven chemicals, seven of which were specifically designed to protect against UVA rays.

As of right now—as was the case fifteen years ago—sunscreen manufacturers in the U.S. are limited to the use of seventeen sunscreen ingredients, only three of which protect against UVA rays. UVA rays are especially dangerous because they deeply penetrate the skin, normally damaging it without showing any immediate signs or symptoms of the damage, such as sunburn.

Skin cancer patient advocates have questioned FDA’s time and resource commitment to sunscreen ingredient review. Such an opinion is quite understandable when one considers the agency’s actions in other areas of its vast regulatory jurisdiction. FDA proudly touts, for instance, that the U.S. is often the first country to approve new prescription drugs and other treatments. In its 2013 Summary, FDA noted that 74% of the drugs approved that year—including two drugs associated with melanoma—were approved here first. FDA also promotes how since 2010 it has “significantly reduced” the length of time it takes for pre-market review of new medical devices.

FDA has, admittedly, taken some actions in recent years related to skin cancer prevention. In 2011, the agency required sunscreen labels to replace the word “waterproof” with “water resistant” and required that the products state how long they remain effective in water. The rule also clarified that manufacturers may only label products as “broad spectrum” if they protect against both UVA and UVB rays. In addition, FDA issued an order earlier this year on sunlamp exposure. The order dictates, among other requirements, that sunlamps be reclassified into a higher risk category and that enhanced warnings be placed on their packaging and in their promotional materials. The cancer prevention benefits that these actions will provide, however, pale in comparison to the benefits improved sunscreens can offer.

Senior agency officials routinely cite FDA’s complex regulatory regime for slowing sunscreen ingredient approval. Unlike in other countries, where sunscreens are regulated as cosmetics, here they are categorized as drug products. Sunscreen makers can pursue approval under FDA’s “monograph” process, which is nominally less rigorous than a formal New Drug Approval. An alternative to that process, known as “Time and Extent” (TEA), allows manufacturers to seek FDA endorsement of chemicals that have been approved and used in other countries. TEA, however, is far from a shortcut; it is in that process that many of the approved-overseas chemicals are currently languishing.

Help may be on the way for American sunscreen consumers from an unlikely source: Congress. On July 28, the House of Representatives passed HR 4250, The Sunscreen Innovation Act. The bill enjoyed broad bi-partisan support. Key provisions require FDA to take action within 8 months on sunscreen ingredients that are pending under the TEA process. New TEA submissions under the TEA process must be reviewed within 11 months. Senators Jack Reed and Johnny Isakson (a melanoma survivor), introduced an identical bill, S.2141, in the Senate last March. The Surgeon General’s July 29 report will undoubtedly have an impact on the Senate’s consideration of the bill.

If the Senate acts on S.2141 soon, and the President signs the eventual conference bill into law, there’s a chance that Americans could be enjoying better sunburn protection as soon as before Labor Day 2015. In the meantime, we will have to rely on the outdated products available to us, and perhaps larger hats and bigger umbrellas, to get us through the rest of this summer and early fall.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s