PASS Expects FDA’s Sunscreen Innovation Approach Will Surprise Capitol Hill

The Public Access to Sunscreens coalition says FDA’s approach to reviewing sunscreen TEA applications is contrary to congressional intent in the Sunscreen Innovation Act and renders the process “virtually meaningless.” The discord largely stems from differing regulatory interpretations and unmet expectations.

The Public Access to Sunscreens coalition expects Congress will be “surprised” by FDA’s Sunscreen Innovation Act procedural outlook, which is at odds with the group’s expectations for streamlining the agency’s evaluation of UV filters already marketed in other countries.

FDA is not implementing the SIA as Congress intended, according to Michael Werner, policy advisor for PASS and a partner at law firm Holland & Knight in Washington.

Werner said that “given the conversations that we had while the bill was being drafted,” he expects Capitol Hill will respond to positions agency officials stated at a recent meeting with the coalition and other stakeholders.

“There’s going to be a lot of members of Congress that are surprised at FDA’s response, that no new sunscreens are expected any time soon despite historic legislative reforms,” he said.

In an interview, Werner expressed frustration with explanations FDA offered, during a Feb. 4 public meeting with stakeholders, about insufficient-data determinations published in 2014 on the six sunscreen time and extent applications the agency reviewed. He noted PASS will continue working to streamline FDA’s TEA process to allow UV filters proven safe in other countries to be marketed in the U.S.

“The idea that companies should spend the money that it takes to get an NDA, which only gives an approval for one formulation of a product, just isn’t realistic. We have to figure out a way to make the TEA process more viable, and work with FDA to make the TEA process a process that works.” – Michael Werner, PASS policy advisor

FDA emphasized the “high bar” sponsors must clear to establish their ingredients as generally recognized as safe and effective, the fundamental for adding an ingredient to an OTC drug monograph. Agency officials suggested it could be several years before firms are able to complete all of the safety testing necessary to cover data gaps and FDA can evaluate their updated dossiers (Also see "Sunscreen TEA Advocates Want Help Scaling FDA’s ‘High Bar’ For OTC Monographs" - Pink Sheet, 6 Feb, 2015.).

Those statements have come as blows to the industry and other SIA advocates who foresaw the legislation opening the gates to bring to market sunscreen ingredients stalled in FDA’s TEA queue, some for longer than a decade.

However, the SIA only imposed deadlines for FDA’s review of TEAs – it did not guarantee GRASE designations.

Moreover, FDA’s 2014 insufficient-data findings for TEAs were issued before the SIA passed and placed the agency under time constraints for its decisions.

The discord between FDA and its detractors largely is a matter of differing regulatory interpretations and unmet expectations on either side, regarding not only SIA’s promise but also the overall TEA system.

From the perspective of many industry stakeholders, the TEA program was created in 2002 to present a streamlined path to market for OTC drug conditions, including active ingredient usage, that previously would have required a new drug application.

Eligible conditions included those backed by safe and effective marketing experience in foreign markets “to a material extent” and “for a material time.”

FDA’s final rule establishing the TEA framework noted conditions found eligible on a TEA basis “would be evaluated for general recognition of safety and effectiveness in accordance with FDA’s OTC drug monograph regulations.”

On its website, the agency currently notes that “at minimum, the general acceptance of a product as GRASE must be supported by the same quality and quantity of scientific and/or clinical data necessary to support the approval of a new drug application.”

However, that was not the universal understanding when the TEA mechanism was introduced. And some, including Werner and PASS, believe FDA’s GRASE requirements have surpassed NDAs in terms of sponsors’ burden of proof.

That notion was corroborated to a large extent during stakeholders’ meeting with FDA. Office of New Drugs Director John Jenkins said “if some ingredients had been submitted as NDAs, they’d probably be approved.”

Such a position puts manufacturers in a difficult spot, according to Werner.

He maintains that NDAs for sunscreens “are not feasible from a business perspective” because sunscreens are not “blockbuster drugs,” but rather inexpensive, seasonal products with multiple formulations that can be manufactured by different companies at the same time.

“The idea that companies should spend the money that it takes to get an NDA, which only gives an approval for one formulation of a product, just isn’t realistic,” he said. “We have to figure out a way to make the TEA process more viable, and work with FDA to make the TEA process a process that works.”

In a summary paper on the meeting, PASS asserts “FDA's approach renders the TEA process virtually meaningless as there is no benefit to waiting five years to develop foreign safety and effectiveness data because companies will either be forced to file for an [NDA] or comply with a testing regime that is equivalent or might even exceed NDA filing requirements.”

Risk-Benefit Metric ‘Off The Table’

PASS further questions FDA officials’ comments underscoring the agency’s rigid stance on safety requirements for TEAs, specifically that “the risk-benefit calculus was ‘off the table’” in decisions on sunscreen TEAs.

Werner says agency should acknowledge the “public health crisis” caused by rising incidence of skin cancer and focus more on that immediate wide-scale threat than any latent risks from sunscreens.

FDA “seems to be turning the risk-benefit calculations on its head,” Werner said. “FDA seems to be more and more worried about a hypothetical risk from products that have been used all over the world for years, in some cases for more than a decade, versus a real risk of skin cancer and melanoma.”

Werner also has concerns about the protocol officials described for FDA meetings with TEA sponsors to discuss data needs and other considerations. According to PASS’s recap, agency officials indicated that a docket would be created for each TEA meeting and the meetings would be open to the public, regardless of proprietary information that may be discussed.

“That’s kind of unusual that a company would have a meeting about their proprietary data for a pending application and it’s not a private meeting with the agency. And if that’s true for other FDA-regulated OTC products, that’s also pretty significant. It remains to be seen how this will play out, but that’s what they were indicating at the meeting,” Werner said.

Center for Drug Evaluation and Research officials at the meeting at the agency’s headquarters in Silver Spring, Md., noted FDA will publish guidance “as soon as possible” to help answer questions about required safety data in sunscreen TEAs. The SIA requires draft guidances within one year of the law’s enactment in late November 2014, and finalized documents within two years (Also see "Sunscreen Innovation Act Starts Clock Ticking On FDA Review Of TEAs" - Pink Sheet, 17 Nov, 2014.).