NDAC Input Sought On Sunscreen Ingredient Data Necessary For Approval
This article was originally published in The Rose Sheet
Executive Summary
FDA’s Nonprescription Drugs Advisory Committee will meet Sept. 4-5 to discuss the scope of safety testing necessary for OTC sunscreen ingredients, following FDA’s rejection this year of three time-and-extent applications to add new sunscreen actives to the OTC monograph. The committee’s input will be valuable if FDA faces deadlines for sunscreen TEA decisions under the Sunscreen Innovation Act, which passed the House July 29.
FDA follows through on a plan sketched earlier this year in its rejection of time-and-extent applications for sunscreen ingredients by scheduling an advisory committee 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 for publication in the July 29 Federal Register.
“The 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 notice adds.
The announcement appears to formalize a plan FDA made in February when it rejected TEAs 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.
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 fall 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, which could be an indication of the types of data that will be discussed at the meeting (Also see "FDA Rejects Sunscreen TEAs, Plans Public Hearing On Ingredient Review" - HBW Insight, 10 Mar, 2014.).
The data listed in the letters included information about sunscreen active ingredients’ effectiveness, associated adverse events and serious side effects, capacity for skin irritation and sensitization, photo-safety, bioavailability, dermal and system carcinogenicity, fertility and fetal development and toxicokinetics.
Aimed at expediting FDA’s review of sunscreen TEA applications and promoting transparency, the Sunscreen Innovation Act passed in the House July 29, prompting the Public Access to Sunscreens coalition to call for passage of the Senate version “as soon as possible.”
FDA’s rejection in June of BASF AG’s TEA to add octyltriazone to the OTC sunscreen monograph 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 systemic exposure to the ingredient, potentially from studies designed to detect and quantify the ingredient’s presence in a subject’s blood or body fluids. It also requested animal studies and data on actual and repeat dose toxicities, genotoxicity and mutagenicity, photocarcinogenity and reproductive toxicity (Also see "FDA Faults BASF Sunscreen Ingredient Data In Latest TEA Rejection" - HBW Insight, 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 that it was intended to be (Also see "Sunscreen Ingredient TEA Decisions Highlight Challenges Of NDA Scale" - HBW Insight, 7 Jul, 2014.).
Advocates for approving additional OTC sunscreen ingredients say many have been available in products marketed in other countries for years and U.S. consumers also should have access to them.
Sunscreen Bill Passes In House
The meeting also comes as legislation is moving through Congress to expedite FDA’s review of TEA applications and require the agency to be more transparent about how sunscreen ingredients can achieve GRASE status.
The Sunscreen Innovation Act (H.R. 4250) passed in the House July 29 by voice vote, after having been amended to require FDA’s decisions on pending sunscreen TEAs within one year, and to review the safety of new TEAs in less than 18 months, according to the Public Access to Sunscreens Coalition. The original bill language, which remains in the Senate bill, proposed eight- and 12-month timeframes for those actions (Also see "Revised House Sunscreen Bill Promotes Review Transparency, Feasibility" - HBW Insight, 16 Jul, 2014.).
The legislation was introduced in March, within weeks of FDA rejecting the first round of TEAs for sunscreen ingredients, aimed at streamlining FDA’s approval process for OTC sunscreen ingredients to ensure a transparent review with a predictable timeline.
In a same-day release, PASS Coalition Policy Advisor Michael Werner states: “Today’s swift action taken by House of Representatives in passing the Sunscreen Innovation Act is a major step toward addressing the urgent public health crisis posed by skin cancer, and particularly melanoma. … The American consumer has waited too long for the latest in sunscreen technology. We now call on the Senate to follow the lead of the House and pass their version of the Sunscreen Innovation Act as soon as possible.”
The Senate version, S. 2141, has not been discussed since being introduced and assigned to the Health, Education, Labor, and Pensions Committee. However, the bill’s sponsors reportedly expect a Senate vote on the legislation in September.
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 delivered piecemeal. Rather than finalize the monograph and changes all 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 untraditional sunscreen formats, including spray and powder sunscreens (Also see "FDA Questions Spray Sunscreen Safety, Efficacy & Monograph Status" - HBW Insight, 27 Jun, 2011.).