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From Health Law Daily, November 23, 2015

FDA puts sunscreen safety on thick with four new guidance documents

By Bryant Storm, J.D.

Four draft guidance documents related to the safety and effectiveness of sunscreen under the Sunscreen Innovation Act (SIA) (P.L. 113-195) were released by the FDA. The draft guidance documents relate to four components of FDA determinations regarding whether an active ingredient in over-the-counter (OTC) sunscreen is generally recognized as safe and effective (GRASE). The documents cover the withdrawal of GRASE requests to the FDA, circumstances governing the formation of an advisory committee to make GRASE determinations, content submissions to support GRASE determinations, and the necessary data to support a GRASE determination (Notice, 80 FR 72970, November 23, 2015; Notice, 80 FR 72972, November 23, 2015; Notice, 80 FR 72973, November 23, 2015; Notice, 80 FR, 72975, November 23, 2015).

Sunscreen approval. Sunscreen in the U.S. is regulated under one of two processes: (1) the new drug approval process (21 C.F.R. Sec. 314) or (2) the OTC drug monograph process (21 C.F.R. Sec. 330). The SIA created new procedures for establishing that nonprescription sunscreen active ingredients under the OTC drug monograph are GRASE and not misbranded when used under the conditions specified in a final sunscreen order (GRASE determination). The SIA process calls for an initial eligibility determination, followed by submissions of safety and efficacy data, and a GRASE determination phase.

Requests. The first draft guidance (80 FR 72970) relates to the process for withdrawing a 586A request for a GRASE determination submitted to the FDA under the federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.). The draft guidance explains that while a manufacturer can withdraw a request, the request will remain part of the public docket and will be published under agency discretion. The guidance describes the specific written and electronic withdrawal procedures and explains how failures to provide the FDA with information in a timely manner will be construed as a withdrawal of a request. The draft guidance also describes the effect that the withdrawal of a 586A request will have at certain points in the evaluation process.

NDAC. The second draft guidance (80 FR 72972) explains the circumstances under which the FDA intends to convene the Nonprescription Drugs Advisory Committee (NDAC) to provide a recommendation as to whether an active ingredient in sunscreen is GRASE. The NDAC is designed to provide independent technical advice as part of a GRASE determination. The draft guidance explains that a decision to convene the NDAC will turn on the public health importance, the controversy, and the complexity involved in a GRASE determination. The guidance also explains circumstances where the FDA is not required to convene the NDAC and informs manufacturers that they are permitted to request that the FDA convene the NDAC to make a GRASE determination.

Submissions. The third draft guidance (80 FR 72973) describes the content and format that the FDA expects for submissions to the FDA in support of a GRASE determination under the SIA. A GRASE determination is based on the FDA’s review of safety and effectiveness data and other information submitted by the request’s sponsor. When submissions are incomplete, the FDA may refuse to file them. Accordingly, the draft guidance intends to prepare manufacturers for a GRASE determination submission. The draft guidance explains that it “does not detail the specific clinical and nonclinical data that should be submitted to support a GRASE determination.” However, the document does identify “key structural elements, topics to be addressed, and recommended organization of a complete and fileable GRASE data submission.”

Data. The final draft guidance (80 FR 72975) addresses the specific data necessary to determine that an OTC sunscreen active ingredient evaluated under the SIA is GRASE. The draft guidance aims to help sponsors identify and obtain the safety and effectiveness information necessary to support a GRASE finding. Data must address clinical testing, including findings from human dermal safety studies, human absorption and maximal use studies, and pediatric considerations. Nonclinical safety testing data should include findings from dermal and systemic carcinogenicity studies, developmental and reproductive toxicity studies, and data regarding animal toxicokinetics. The FDA also expects to receive data on post marketing safety, effectiveness testing, and anticipated final formulation testing.

MainStory: TopStory FDAGuidanceNotices FDCActNews AdulterationNews ClinicalNews DrugBiologicNews MisbrandingNews OTCNews PrescriptionDrugNews SafetyNews

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