NDAC Input Sought On Sunscreen Ingredient Data Necessary For Approval

FDA’s Nonprescription Drugs Advisory Committee will meet Sept. 4-5 to discuss the scope and safety of testing necessary for OTC sunscreen ingredients. The announcement comes after FDA earlier this year rejected time and extent applications to add new sunscreen actives to the OTC monograph.

FDA is following through on a plan noted earlier this year in its rejection of time and extent applications for sunscreen ingredients by scheduling an advisory committee meeting to discuss the scope of safety testing necessary for OTC approval of such ingredients.

The Nonprescription Drugs Advisory Committee will meet Sept. 4-5 at FDA’s White Oak Campus headquarters in Silver Spring, Md., to discuss the need for various types of safety data, including clinical and nonclinical data, for sunscreen ingredients, according to a notice prepared published in the July 29 Federal Register.

“The discussion will take into consideration that sunscreens are typically used chronically in ingredients over the age of six months to help prevent skin cancer and skin aging,” the notice adds.

The announcement appears to formalize a plan FDA made in February when it rejected time and extent applications by 3V Inc., [Symrise AG]and Ego Pharmaceuticals Pty. Ltd for sunscreen ingredients amiloxate and diethyhexyl butamido triazone. FDA said the TEAs had insufficient data to support the ingredients’ status as generally recognized as safe and effective.

A time and extent application a procedure to incorporate a new product or a product condition (such as an active ingredient or botanical drug substance) in an OTC drug monograph.

FDA said in letters to the firms that it would hold a public meeting in the spring of 2014 “to discuss current considerations in FDA’s evaluation of OTC sunscreen active ingredients.” Agency officials since then have said the meeting would be later in the year.

The agency also listed in the letters specific additional information it needed from the firms to determine the ingredients’ GRASE status (Also see "MHRA on herbals" - Pink Sheet, 31 Jul, 2006.).

“We are looking to understand the NDAC’s perspective on the recommendations” in the TEA feedback letters, an FDA spokesman confirmed.

FDA’s approach to adding new ingredients to the OTC monograph is only one part of the agency’s fragmented overhaul of how sunscreens are regulated. The agency continues to work through feedback it received in 2007 when it proposed a final sunscreen monograph in a piecemeal fashion.

The data listed in the letters included information about sunscreen active ingredients’ effectiveness and effect on skin irritation and sensitization, photo-safety, bioavailability, adverse events and serious side effects, dermal and system carcinogenicity, fertility and fetal development and toxicokinetics.

FDA’s rejection in June of BASF AG’s TEA to add octyltriazone to the OTC sunscreen monograph also revealed more details on the type of information the agency deems necessary to approve new ingredients.

In a letter to the firm, FDA said it needed information about the systemic exposure of the ingredient, such as from studies designed to detect and quantify the ingredient in a subject’s blood or body fluids. It also requested animal studies and data on actual and repeat dose toxicities, genotoxicity and mutagenicity assay, photocarcinogenity and reproductive toxicity (Also see "FDA Faults BASF Sunscreen Ingredient Data In Latest TEA Rejection" - Pink Sheet, 24 Jun, 2014.).

FDA’s rejection of the three TEAs came years after they were submitted – signaling to many that the TEA process is broken and not the efficient method for adding ingredients to the OTC monograph it was intended as (Also see "TEA Changes, GRASE Basics Central To CHPA Monograph Comments" - Pink Sheet, 15 May, 2014.).

Advocates for approving additional OTC sunscreen ingredients say many have been available in products marketed in other countries for many years and U.S. consumers also should have access to them.

Legislation Could Have Influence

The meeting also comes as Congress considers legislation to require FDA to be more transparent about how sunscreen ingredients can become recognized as GRASE (Also see "Revised House Sunscreen Bill Promotes Review Transparency, Feasibility" - Pink Sheet, 21 Jul, 2014.).

The Sunscreen Innovation Act – H.R. 4250 and S. 2141– was introduced in March, within weeks of FDA rejecting the first round of TEAs for sunscreen ingredients, to streamline FDA’s sunscreen approval process for OTC sunscreen ingredients to ensure a transparent review with a predictable timeline.

While S. 2141 has not been discussed since being introduced and assigned to the Health, Education, Labor, and Pensions Committee, the House passed its bill July 28 after amending it to direct FDA to issue decisions on pending sunscreen TEAs within one year, and to review the safety of new TEAs in less than two years.

The original bill language, which remains in the Senate bill, proposed eight- and 12-month timeframes for those actions.

H.R. 4250 also would require FDA to be more forthcoming on how sunscreen applicants can achieve the status of generally recognized as safe and effective for their ingredients, which is required for substances to be added to over-the-counter drug monographs prior to market entry.

If FDA’s Center for Drug Evaluation and Research fails to meet these deadlines, the application would go to the Office of the Commissioner for review within 60 days.

While the Senate bill dictates specific safety and testing requirements for sunscreen TEAs that FDA would evaluate – including data on skin and eye irritation, sensitization, absorption rates across various skin types/conditions, carcinogenicity and endocrine disruption, among other safety and toxicity endpoints – H.R. 4250 leaves it up to the agency to set the requirements.

Final Monograph Remains In Limbo

FDA’s approach to adding new ingredients to the OTC monograph is only one part of the agency’s fragmented overhaul of how sunscreens are regulated.

The agency continues to work through feedback it received in 2007 when it proposed a final sunscreen monograph in a piecemeal fashion. Rather than finalize the monograph and changes at once, the agency has opted to use enforcement discretion and issue separate rules for different components of the monograph.

For example, in 2011 it issued a final rule on testing and labeling requirements for sunscreens and a separate advanced notice of proposed rulemaking on the safety and efficacy of several sunscreen formulas, including spray and powder sunscreens (Also see "FDA Questions Spray Sunscreen Safety, Efficacy And Monograph Status" - Pink Sheet, 27 Jun, 2011.).

[Editor’s note: Each week, “The Pink Sheet” includes a story contributed by “The Tan Sheet” highlighting a current topic in the consumer medicines or nutritional supplements sectors.]