Posted 24 February 2015 | By Alexander Gaffney, RAC,

Despite congressional pressure to approve several new sunscreen ingredients long pending before reviewers, the US Food and Drug Administration (FDA) says it will not bow to pressure and will instead continue to insist the companies provide it with data to show the products are both safe and effective.

Background

FDA's regulation of sunscreen ingredients popped up as a major issue starting in late 2013, when sunscreen manufacturers banded together to form a coalition aimed at persuading Congress to reform a rarely used regulatory pathway known as the "Time-and-Extent" (TEA) process.

At its inception in 2002, the TEA process was envisioned as a regulatory shortcut of sorts. If a drug had been marketed in another country—England, for example—a company could obtain regulatory approval from FDA by showing that it had been marketed for a meaningful time and to a meaningful extent, and was therefore safe for use in the US.

That's the theory, anyway. In practice, the TEA process has rarely been used, and has proven to be anything but a shortcut. That's because regulators still have questions about the safety or efficacy of a product, regardless of how long or to what extent a product has been used elsewhere. The process can also point out glaring differences between the manner in which drug products are approved in various regions. In Europe, for example, sunscreen ingredients are regulated as cosmetic products, and are not subject to an extensive regulatory review process or rigorous adverse event reporting after approval. In the US, a sunscreen ingredient is regulated as a drug, and is subject to rigorous pre-market review and postmarket monitoring.

Congressional Action

In December 2014, US President Barack Obama signed into law the Sunscreen Innovation Act (SIA), a law intended to make reforms to FDA's TEA process in the hopes of getting new sunscreen ingredients approved more quickly.

Supporters of the bill cited the amount of time taken to review eight sunscreen ingredients. Three—amiloxate, enzacamene and octyl triazone—had been under review since 2003, and several other ingredients have been under review for almost as long. Legislators, citing surging rates of skin cancer in the US, said the new ingredients could potentially help protect patients.

The SIA aimed to speed up FDA's review of these products by requiring it to, within 60 days, notify a sponsor of an existing sunscreen TEA application if its application is sufficiently complete to support a regulatory approval decision.

New Rejections

FDA now has an answer for all existing sunscreen applicants: Your applications don't contain enough data.

That's not necessarily an unexpected outcome. As Regulatory Focus wrote in July 2014 after the SIA was approved by the US House of Representatives:

"A key question for proponents of the bill may be if it succeeds in accelerating the approval of sunscreen ingredients, or simply leads to more timely rejections of applications by FDA regulators."

As explained in a blog posting on FDA's website, in the case of all eight ingredients, FDA regulators found that companies had not sufficiently shown the sunscreen ingredients were "generally regarded as safe and effective"—the threshold all over-the-counter drug ingredients must meet before being approved.

"We tentatively determined … that we need more data to decide if these ingredients are, in fact, GRASE for use in OTC sunscreen products," wrote Theresa Michele, FDA's director of Nonprescription Drug Products.

As such, all eight ingredients have been rejected and sent back to applicants with requests for additional data.

The post goes on to explain that while TEA-type data is useful at showing general safety and efficacy, it doesn't provide regulators with an adequate understanding of how the drug might affect pregnant women or babies, for example.

"The law does not change FDA’s standard for general recognition of safety and effectiveness," Michele added.

FDA Voice