Docket No. FDA-2015-D-3990 Sunscreen Innovation Act: Section 586C(c) Advisory Committee

Transcription

1 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Rm Rockville, MD Via Fax: RE: Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process; Draft Guidance for Industry, Docket No. FDA-2015-D-3990 Dear FDA Desk Officer, The Natural Products Association (NPA) is submitting this letter as formal comments to Docket No. FDA-2015-D-3990 Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process; Draft Guidance for Industry, published in the Federal Register on November 23, 2015 (80 FR 72972) On behalf of the Natural Products Association (NPA), we thank you for the opportunity to comment on this important regulatory matter. NPA was founded in 1936 to promote and protect the unique values and shared interests of retailers and suppliers of natural nutritional foods and natural products. NPA is a non-profit 501(c) (6) association whose mission is to advocate for the rights of consumers to have access to products that will maintain and improve their health, and for the rights of retailers and suppliers to sell these products. We are the

2 Page 2 oldest and largest trade association in the natural products industry representing over 1,900 members accounting for almost 10,000 retail, manufacturing, wholesale, and distribution locations of natural products, including foods, dietary supplements, and health/beauty aids. NPA created the natural standard for the personal care industry, and since 2010 the NPA Natural Seal Standard has certified over 1,500 personal care ingredients and products, many of which include sunscreen products. As such, the policies which dictate the Nonprescription Drug Advisory Committee (NDAC) meeting process is of great importance to us and to NPA members. Executive Summary NPA Applauds FDA for Establishing Policies Directing NDAC Meetings with Regards to 586A Requests NPA urges the Agency to Allow for Additional 586A Requests to be Presented to the Advisory Committee Per NDAC Meeting NPA Does Not Support the Early Sponsor Request for NDAC Meeting Background The Sunscreen Innovation Act (SIA), enacted on November 24, 2014, established a new process for the safety and efficacy review of active ingredients in non-prescription sunscreens and added 586D(a)(1) to the Food Drug & Cosmetic (FD&C) Act. 1 Prior to the SIA, the Time and Extent Applications (TEA) process was the sole regulatory process in place that allowed FDA to evaluate active ingredients used in over-the-counter (OTC) products, which includes non- 1 Section 586D(A)1() of the FD&C Act (21 U.S.C. 360fff-4(a)(1))

3 Page 3 prescription sunscreens. The SIA supplements the TEA process, amending the FD&C Act and establishes new procedures to ensure that nonprescription sunscreen active ingredients or combinations of active ingredients are GRASE and not misbranded. Currently, sunscreen products are regulated by one of two processes: New Drug Approval (NDA) process (21 CFR part 314) OTC Drug Review (21 CFR part 330), as supplemented by the SIA If an active ingredient is currently listed under an OTC monograph, the sunscreen product does not require additional FDA approval before being marketed. However, if a product contains an active ingredient not listed under an OTC monograph, it must first gain FDA approval through the New Drug Application (NDA) process before a company may market or sell the OTC product. Throughout the review process, it is the company s responsibility to provide sufficient data to determine if the active ingredient is safe and effective. Once the active ingredient is approved as GRASE through the NDA process, the company has the option to have the ingredient included as part of an OTC monograph. If an active ingredient qualifies as an OTC drug in the US and was only marketed outside the U.S., the active ingredient would additionally be required to receive pre-market approval through the NDA process (Section 505 FD&C Act) prior to marketing the active ingredient in the U.S. Finally, if an active ingredient was marketed before the OTC drug review process began in 1972, a pre-market approval through the NDA process (Section 505 FD&C Act) would also be required. Prior to the enactment of the SIA, the TEA process was the only way a company could request a nonprescription active ingredient be included in the OTC drug monograph system.

4 Page 4 The TEA process is a two-step process, whereby the company first submits a TEA application to deem the nonprescription drug active ingredient to be eligible for GRASE. Once the TEA application is approved, FDA publishes a notice of eligibility and requests data on the safety and efficacy of the active ingredient. Safety and efficacy data may be submitted to the FDA by the sponsor as well as by the general public. Similar to the TEA process, the SIA process is initiated with an initial eligibility determination phase, which is then followed by submission of safety and efficacy data, and finally a GRASE determination is made. However, unlike the TEA process, the SIA dictates determination by the Agency in the form of orders. The Advisory Committee is an essential component of FDA drug reviews and an important piece of the 586A review and SIA process. The Nonprescription Drugs Advisory Committee (NDAC), established under the Federal Advisory Committee Act, 2 was created to offer independent expert advice to the Agency in matters regarding complex scientific, technical, and policy issues. 3 The Agency will be responsible for identifying additional members (including experts such as dermatologists), 4 preparing all briefings and presentations, publishing notice of the NDAC meeting in the Federal Register, as well as organizing all logistics of the NDAC meetings. The Agency notes in the draft guidance the process of arranging a NDAC meeting may take anywhere between four and six months 5 and encourages sponsors to request NDAC meetings as early in the 568A process as possible. NPA commends the steps taken by FDA to 2 Public Law (5 U.S.C. Appendix) 3 Advisory Committees: Implementing Section 120 of the Food and Drug Administration Modernization Act of 1997 (Advisory Committee Guidance), 4 Advisory Committee Guidance, supra note 8, at 2. 5 Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process Guidance for Industry

5 Page 5 implement Section 586C(c) Advisory Committee Process. However, we would like to address several concerns in the current draft guidance. NPA urges the Agency to allow for Additional Requests to be Made to the Advisory Committee Per Meeting NPA is concerned with the policies governing the NDAC as they are currently laid out in Section 586C(c) of the FD&C Act. Specifically, our concerns lie in the frequency with which the committee meets and the maximum number of pending 586A requests allowed to be reviewed by the committee per meeting. In the draft guidance, it is stipulated FDA is not required to 1) convene the NDAC more than once with respect to any request under section 586A or any pending request; 2) convene the NDAC more than twice in a calendar year with respect to review under this section; and 3) submit more than a total of 3 requests under section 586A or pending requests to the Advisory Committee per meeting. 6 Under these limitations NDAC will review a maximum of six 586A requests per year. This scheduling does not allow for many reviews over a 12 month period. The FDA issued a draft guidance in 2008 regarding the convening of advisory committee meetings. The draft guidance does not address the frequency with which meetings may be held but instead references the grounds which warrant the convening of an advisory committee. The factors in which the FDA warrant the convening of the advisory committee include the following: 6 Section 586B(b)(3)(A), 586C(a)(4), and 586C(b)(7) of the FD&C Act (21 U.S.C. 360fff-2, 360fff-3)

6 Page 6 1) Is the matter at issue of such significant public interest that it would be highly beneficial to obtain the advice of an advisory committee as part of the agency s regulatory decision-making process? 2) Is the matter at issue so controversial that it would be highly beneficial to obtain the advice of an advisory committee as part of the agency s regulatory decision-making process? 3) Is there a special type of expertise that an advisory committee could provide that is needed for the agency to fully consider a matter? 7 Sun protection is a significant public health issue in the United States and skin cancer is one of the most common cancer diagnoses. In 2012 alone, over 67,000 people were diagnosed with a skin melanoma. 8 The high rate of skin cancer incidences suggests that new active ingredients, developed to improve sunscreens, would qualify as a matter significant to public health. Moreover, within the NDAC s Charter, no limitations have been placed on the frequency with which NDAC meetings may be scheduled to review OTC drug products. Within the NDAC Charter, FDA estimates NDAC meetings will convene approximately four times over a calendar year. 9 In 2014 the committee met a total of five times. 10 Currently, in the FDA's tentatively scheduled advisory committee meetings for 2016, the NDAC has not yet determined to be needed and therefore has not been scheduled to date. 11 Since NDAC meetings are often 7 Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings 8 Skin Cancer Statistics 9 Nonprescription Drugs Advisory Committee Charter: mmittee/ucm htm 10 Which of FDA's Drug Advisory Committees Were Most Active in 2014? - See more at: Were-Most-Active-in-2014/#sthash.6IcyaxyR.dpuf Advisory Committee Tentative Meetings:

7 Page 7 scheduled months in advance, the absence of any scheduled meeting implicates a lack of OTC drug products to be reviewed. NPA believes that placing limitations on the frequency of NDAC meetings and 586A requests reviewed during NDAC meetings will create a significant backlog of 586A requests. The enactment of the SIA was intended to increase the efficiency at which sunscreen active ingredients products are reviewed by FDA. New and potentially safer sunscreen active ingredients have been developed for almost a decade. These same active ingredients are often approved as safe and effective for use in sunscreen products in other countries. However, these active ingredients are unavailable to the American consumer because of delays in FDA s regulatory process. There are currently six active sunscreen ingredients pending review, 12 and therefore, it seems unlikely that the NDAC, under the limitations in the draft guidance, would be able to meet and review the pending 586A requests in the 60-day timeframe to remain compliant with the SIA. Additionally, if new 586A requests are submitted in 2016, it seems more than likely that these requests would not be reviewed until 2018 due to the stipulations laid out in this draft guidance. This delay, created by imposing strict NDAC meeting limitations, appears contradictory to the goals of the SIA. Moreover, if review of active ingredients is delayed by Agency-imposed limitations on the 586A requests presented during NDAC meetings, it further prevents the American consumer from accessing new, innovative, and potentially more efficacious OTC sunscreen products. Furthermore, the limitations placed on the frequency with 12 Regulatory Policy Information for the Sunscreen Innovation Act:

8 Page 8 which the NDAC is allowed to meet and review 586A requests appears to be arbitrary compared to the review polices set for all other OTC drug products. NPA requests FDA to make provisions regarding the frequency of NDAC meetings held concerning 586A requests or that the Agency increase the number of 586A requests allowed to be presented to the NDAC for the duration of the first two years of the implementation of the SIA or until NDAC is able to review requests within twelve months of submittal. NPA Does Not Support the Early Sponsor Request for NDAC Meeting In the draft guidance, the Agency places strict limitations on the frequency with which the NDAC can review 586A requests, but it places no constraints on the timeframe a sponsor can submit a request for a NDAC meeting. The draft guidance states that a sponsor can request FDA to convene the NDAC and should submit such request as early as possible even while the 586A request is still pending. NPA does not support that NDAC requests should be made as early as possible. In the draft guidance, FDA repeatedly iterates that it values the time of NDAC members, realizes the committee requires a significant time commitment, and limits the use of such meetings to important matters. However, encouraging a sponsor to submit a NDAC meeting request so early in the process will result in the misuse of the NDAC s already limited time to spend on 586A pending requests. Furthermore, as FDA is responsible for convening NDAC meetings, FDA will be required to devote considerable resources identifying additional members, preparing all briefing and presentations, publishing notice of the NDAC meeting in the Federal Register, and organizing logistics of the NDAC meetings. It appears senseless for FDA to spend resources organizing an

9 Page 9 NDAC meeting to review an active ingredient when the active ingredient in question has not yet received a filing determination. NPA proposes the Agency modify the current draft guidance to urge sponsors to submit NDAC meeting requests only when the 586A request is no longer pending. NPA is confident that this modification to the guidance document will ensure the NDAC s time is confined to important matters by limiting the reviews to only non-pending requests, expediting the active ingredient review process, and ensuring sunscreen products are GRASE and not misbranded. Conclusions The NDAC is an important component of FDA drug review and an important piece of the 586A review and SIA process. NPA urges the Agency to allow for additional requests to be made to the advisory committee per meeting. We do not support the current draft guidance, specifically the frequency which the NDAC committee meets and the maximum number of pending 586A requests allowed to be reviewed by the committee per meeting. Furthermore, we believe that placing limitations on the frequency of NDAC meetings and 586A requests reviewed during NDAC meetings will create a significant backlog of 586A requests. The backlog of 586A requests caused by Agency imposed limitations, further prevents the American consumer from having access to new and potentially more efficacious OTC sunscreen products and directly contradicts the objectives of the SIA. Additionally, NPA does not support the early sponsor request for an NDAC meeting. NPA believes it is senseless for FDA to spend valuable resources organizing an NDAC meeting reviewing an active ingredient when the active ingredient has not yet received a filing determination. If FDA truly wishes to restrict the time of the NDAC to important matters than

10 Page 10 it would benefit the Agency to only accept NDAC meeting requests from requests that have already received a filing determination. NPA thanks FDA for the opportunity to comment on this draft guidance. NPA applauds FDA s establishment of the Advisory Committee Process an important step in the enactment of the SIA. However, we would like FDA to reconsider the frequency which the NDAC meets as well as the number of pending 586A requests reviewed by the committee. In addition, NPA recommends the Agency allow for an NDAC request to be made only when a request is no longer pending. We believe expediting the process which sunscreen active ingredients are reviewed will greatly serve the American consumer, allowing them access to new efficacious sunscreen products which will support the important goal of reducing instances of skin cancer in the United States. NPA again thanks the FDA for the opportunity to comment on this important regulatory process, and we look forward to working with FDA as they continue to develop and implement the SIA. Sincerely, Daniel Fabricant, Ph.D. CEO, Executive Director Natural Products Association