US FDA's Sunscreen Progress Gets Dim Review From Congressional Appropriators

House and Senate appropriators' take note that US FDA has not approved an additional OTC sunscreen ingredient since the 2014 passage of the Sunscreen Innovation Act.

In separate reports on FDA's budget, House and Senate funding committees both say they are "significantly concerned" about FDA's progress to permit marketing of  new sunscreen ingredients to be made available.

The Senate report points out that FDA has not approved an additional OTC sunscreen ingredient since implementation of the 2014 Sunscreen Innovation Act. The statute directs FDA to finalize an effective sunscreen monograph within five years and sets deadlines for detailing the process to be used in steps in evaluating applications for adding ingredients or making other changes to the monograph.

The House and Senate passed separate bills setting FDA's fiscal 2019 direct appropriation from the US Treasury as well as user fee amounts. The House approved its bill in mid-July and the Senate approved its version of the bill on Aug. 1. Each bill is discussed in a report by the respective chambers' Appropriations Committee. In addition to reviewing legislative provisions, these reports provide a vehicle for legislators to elaborate on their thinking, air concerns about agency performance, and suggest additional actions not required by the bills. Congressional leaders have not announced a timeline for reconciling differences between the bills before before the current fiscal year ends on Sept. 30.

The House bill includes $3.17bn total direct appropriation for FDA in FY2019, up from $2.8bn for FY2018, and $2.46bn total user fees, up $from2.3bn, putting the agency's total spending approved by the House at $5.57bn. The Senate's FY2019 levels are $2.96bn direct appropriation and $2.46bn in user fees for total spending of $5.63bn for the next fiscal year, which begins Oct. 1.

For the Center for Drug Evaluation and Research, which has oversight for all OTC drugs available in the US as well as prescription products, the House bill sets total spending at $2.76bn, including direct appropriation of $1.8bn and $960.6m in user fees. The Senate's figures for CDER are $2.68bn total from $1.72bn in direct appropriation and $906.6m in user fees.

Monograph Fees Noted As 'Proposal'

House and Senate appropriators that a user fee program to support FDA's OTC drugs monograph work has not been established but is included in legislation that would modernize and streamline the agency's regulations for adding ingredients, indications or dosage forms to a monograph. While Senate appropriators estimate the potential user fee amount, their House counterparts demurred.

The House committee's "recommendation does not include proposed user fee increases for ... Over-the-Counter Monograph until such fees are authorized in law," according to its report. The Senate panel, on the other hand, listed the fees as a "(legislative proposal)" and estimated the FY2019 total would be $22m.

A bill the House passed in July, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, H.R. 5333, would allow FDA to use administrative orders, rather than conduct notice-and-comment rulemakings, to change monographs, which govern the majority of OTC drugs available in the US. A Senate monograph reform bill, S. 2315, was approved by the Health, Education, Labor and Pensions Committee, but a full Senate vote is yet to be scheduled.
(Also see "House Passes US OTC Monograph Reform And Committee Clears HSA Change" - Pink Sheet, 18 Jul, 2018.)

The current House and Senate measures differ mainly on marketing exclusivity periods, an issue that, should the Senate pass its bill as currently written, likely would be ironed out in eventual conference committee negotiations.

In addition to their sunscreen comments, appropriators from both chambers direct FDA to tighten its oversight of vitamin, mineral and supplement manufacturing and marketing, though they are not aligned on funding for the agency's work in the area. The Senate bill also suggests the agency accelerate efforts to create a pathway for approval of products as medical food that is made available under a physician's direction (see sidebar below).

Spray Rule Has Senate's Attention

Regarding sunscreen ingredients, the Senate report offers detailed views on new ingredient reviews. It "directs the FDA to meet with sponsors regarding the development of a testing regimen for sunscreen ingredients, consistent with current scientific standards, that appropriately balances the benefit of additional skin cancer prevention tools versus the risk of skin cancer.

Sunscreen ingredient firms and other stakeholders contend FDA is setting its bar too high to approve ingredients as generally recognized as safe and effective, the threshold criteria for adding ingredients to a monograph. The bar is particularly high for substance safety, they say. Through the time and extent application pathway, sponsors have proposed adding to the sunscreen monograph ingredients with a history of use in other countries, but FDA is asking for broader and more in-depth data on the ingredients' safety than firms have provided. (The TEA pathway is another route for getting new ingredients approved, based on data drawn from being marketed for a material time and extent in other countries.)

The Senate panel also "is disappointed FDA has yet finalized a rule limiting the maximum sun protection factor to ``50'' or ``50+'' as required by the FY2018 Consolidated Appropriations Act that Congress passed in February. The committee "directs FDA to finalize the rule immediately." (Also see "Gottlieb Showing Capitol Hill Skills With Funding Success" - Pink Sheet, 24 Mar, 2018.)

Additionally, Senate appropriators noted disappointment in FDA failing to issue a proposed rule to establish testing and labeling standards for sunscreen sprays and directed "FDA to do so immediately."

Although a proposed rule has not been published, FDA did issue guidance in May stating that spray sunscreens are compliant when the products' active ingredients are tested as required in the Center for Drug Evaluation and Research's a 2011 advanced notice of proposed rulemaking on GRASE standards for sprays and other novel sunscreens and are labeled with information on usage and application not required for other dosage forms. The 2011 ANPR directed sunscreen manufacturers to submit data on the safety of spray and other novel forms of sunscreen. (Also see "Spray Sunscreens Stay In FDA Enforcement Discretion Shade" - Pink Sheet, 23 May, 2018.)

House Notes Skin Cancer Rates, Surgeon General Call

The House report comments that US consumers lack additional choices in sunscreens "despite increased skin cancer rates in the United States, the Surgeon General’s 2014 Call to Action to Prevent Skin Cancer, unanimous passage of the Sunscreen Innovation Act (SIA) in Congress and having a number of ingredients pending approval for more than 15 years." It directs FDA to continue to work with application sponsors "to reach a path forward on a testing regimen for sunscreen ingredients that is consistent with current scientific standards, has a proven track record with sunscreen ingredients, and appropriately balances the benefit of additional skin cancer prevention tools."

In addition to its enforcement guidance on sprays and other novel sunscreens, CDER in May released draft guidance that underscores FDA increasing reliance on maximal usage trials to support including sunscreen and other topical ingredients in OTC drug monographs. The document could have more companies contemplating new drug approval pathways as an alternative to GRASE review, a process in which stakeholder confidence has eroded significantly since its implementation in the early 1970s. (Also see "FDA’s MUsT Draft Guidance Extends Challenge To Wider OTC Drug Industry" - HBW Insight, 22 May, 2018.)

From the editors of the Tan Sheet.