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Regulatory Focus™ > News Articles > House Legislators Clear Sunscreen Innovation Bill, but Questions Remain

House Legislators Clear Sunscreen Innovation Bill, but Questions Remain

Posted 29 July 2014 | By Alexander Gaffney, RAC

House Legislators Clear Sunscreen Innovation Bill, but Questions Remain

The US House of Representatives has voted in favor of a bill that would require the US Food and Drug Administration (FDA) to speed up its assessment process for new sunscreen ingredients that have been awaiting regulatory approval for as long as a decade in some cases.


The bill, the Sunscreen Innovation Act(H.R. 4250) requires FDA legislators to speed up their review of sunscreen ingredients submitted under the Time-and-Extent Application (TEA) process.

That process allows companies to submit applications for approval (based on amending existing monographs) based not on original clinical trials data, but instead based on a product's record of safe use in another country or regulatory region, such as the EU.

Sponsors of TEAs must undergo a five-part process, any part of which can experience lengthy delays:

  1. Sponsor must generate a TEA application, including information about the drug, the time and extent of its marketing, and its use.
  2. FDA must then determine if the drug is eligible under the monograph system. In essence: Would this drug be able to be used without the supervision of a healthcare professional by most people?
  3. The TEA submission is then opened to public comment, including comment from rival manufacturers and public interest groups.
  4. FDA determines whether the ingredient is generally regarded as safe and effective (GRASE), and thus eligible under the monograph system.
  5. FDA then proposes and later finalizes a regulation (rule) on adding the drug ingredient to the sunscreen monograph. In some cases, it also publishes an advanced notice of public rulemaking, which is a notice that it plans to issue a draft regulation in the future.

At present, there are at least eight ingredients pending before FDA, all of which are seeking approval under the TEA process. The problem for some of those ingredients: Sunscreen ingredients are regulated as cosmetic products in the EU, but as drugs in the US, meaning some products don't have much data regarding their safety or efficacy—or at least not data meeting FDA's expectations.

The result has been years of delays. At least three ingredients have been awaiting FDA approval since 2003, while two others have been awaiting approval since 2005. Three others have been on hold since 2006, 2008 and 2010, respectively.

For more on the regulation of sunscreen ingredients, please read Focus' Regulatory Explainer on the topic.

The Sunscreen Innovation Act: New Drugs

The bill would require FDA to review new sunscreen ingredients seeking over-the-counter (OTC) approval more quickly.

The bill calls for FDA to conduct an initial review of an application within 60 days to determine if it is complete, at which point the agency would either accept the application or send it back to the filer for additional details. Companies can also appeal a refuse-to-file decision, the legislation states. (More on 'refuse-to-file' determinations here)

Once a drug application is accepted by FDA and filed, the agency then has 300 days—about 10 months—to complete a review of the application. Because the application is for OTC status, FDA isn't just looking to determine if a drug is safe and effective—it's looking to find that a drug is GRASE.

As explained on FDA's website, finding a drug to be GRASE hinges on three findings:

  1. Evidence—well-controlled clinical investigations—indicates that the drug is safe and effective.
  2. That evidence has been published and is available for scrutiny by qualified experts.
  3. Experts agree that the product is safe and effective.

Because OTC products are used without the supervision of a doctor, they are generally held to very high standards of safety, and should be for conditions that are amenable to self-diagnosis (which isn't really a factor for the review of sunscreen).

After a positive decision is made, FDA is then supposed to issue a proposed rule within 60 days regarding its intent to approve the drug, which should be subject to a 45-day comment period. Ninety days after the close of the comment period, FDA should issue its final regulation

Within that same 300-day period, FDA can also convene an advisory committee meeting to review each new sunscreen ingredient.

If FDA fails to approve an ingredient within the required amount of time, the application will be elevated within FDA to the commissioner for immediate action.

Further information requests from FDA should, once the company responds, be reviewed by FDA within 210 days, the legislation states.

Sunscreen ingredients that have already been under FDA review—sometimes for years—will be treated much in the same way as new filings, but under an accelerated timeframe for approval, and with the option for sponsors to convene an advisory committee meeting if they want one.

Other Bill Provisions

The bill also calls for the Government Accountability Office (GAO) to file a report on FDA's efforts within one year of the passage of the Sunscreen Innovation Act, and for FDA to issue a guidance document on bringing a sunscreen ingredient to market using the Time and Extent process.

Bill Passes

On 28 July 2014, the House of Representatives agreed to pass the bill based on a unanimous voice vote—an extraordinary rarity in a political environment in which healthcare legislation had been a near-constant source of tension.

The bill now heads to the Senate, where an identical companion bill, S.2141, has experienced similar levels of bipartisan support and is expected to pass.

The bill's passage came on the same day FDA issued a meeting notice indicating that its Nonprescription Drug Advisory Committee (NDAC) plans to meet in early September 2014 to discuss "the scope of safety testing that should be required for sunscreen active ingredients to be marketed in U.S. over-the-counter (OTC) sunscreen products."

Explained FDA: "This discussion will take into consideration that sunscreens are typically used chronically in individuals over the age of 6 months to help prevent skin cancer and skin aging. The need for various types of safety data, including clinical data and nonclinical data, will be discussed."

Will the Bill Succeed?

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.

One key problem underlying most applications so far has been a lack of data. While the US regulates sunscreen ingredients as drugs, some markets, such as the EU, regulate them as cosmetic products, leaving sponsors with less data than FDA would like to establish a product's safety and efficacy.

For example, see FDA's rejection letter regarding the proposed sunscreen ingredient diethylhexyl butamido triazone. "We have reviewed the available public data on diethylhexyl butamido triazone for use in OTC sunscreens," FDA writes. "Based on that review, we have made an initial determination that the scientific record is not sufficient to establish that diethylhexyl butamido triazone is GRASE for OTC sunscreen use."

FDA said it has concerns that companies hadn't conducted small-scale studies to indicate the safety of the products, which could potentially cause photosensitivity, irritation and skin sensitivity. Sponsors hadn't always conducted bioavailability of pharmacokinetic studies, either, FDA said—both basic elements of most drug safety and efficacy reviews outside the TEA process.

Ultimately, while the Sunscreen Innovation Act might place political pressure on FDA to approve at least some of the applications under review more quickly, it might also serve to highlight the deficiencies of those same applications—and the TEA process.


Sunscreen Innovation Act

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