Source: https://www.federalregister.gov/articles/2014/02/24/2014-03884/over-the-counter-drug-monograph-system-past-present-and-future-public-hearing
Timestamp: 2015-09-03 02:30:33
Document Index: 719729883

Matched Legal Cases: ['art 330', 'art 330', '§ 330', '§ 330', '§ 330', '§ 330', '§ 15', '§ 15', 'art 15', 'art 10', '§ 10', '§ 10', '§ 15', 'art 15', '§ 15']

Federal Register | Over-The-Counter Drug Monograph System-Past, Present, and Future; Public Hearing
Dates: Public Hearing: The public hearing will be held on March 25 and 26, 2014, from 9 a.m. to 4 p.m. The meeting may be extended or may end early depending on the level of public participation. Register to attend or provide oral testimony at the meeting by March 12, 2014. See Registration and Request To Provide Oral Testimony for information on how to register or make an oral presentation at the meeting. Written or electronic comments will be accepted until May 12, 2014.
-10172 (5 pages)
Document Number: 2014-03884
Shorter URL: https://federalregister.gov/a/2014-03884 Action
The public hearing will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, rm. 1503A, Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Registration and Request To Provide Oral Testimony: The public hearing is free and seating will be on a first-come, first-served basis. If you wish to attend the public hearing or make an oral presentation, see section IV of this notice (Attendance and/or Participation in the Public Hearing) for information on how to register and the deadline for registration. For those who cannot attend in person, information about how to access a live Webcast of the meeting will be located at: http://www.fda.gov/Drugs/NewsEvents/ucm380446.htm.
FDA's regulations in 21 CFR part 330 describe the conditions for a drug to be considered generally recognized as safe and generally recognized as effective (GRAS/GRAE) and not misbranded. If a drug meets each of the conditions contained in part 330, as well as each of the conditions contained in any applicable OTC drug monograph, and other applicable regulations, it is considered GRAS/GRAE and not misbranded, and is not required by FDA to obtain approval of a new drug application (NDA) under section 505 of the FD Act (21 U.S.C. 355).
The lengthy notice and comment rulemaking procedures for evaluating each therapeutic category are set forth at § 330.10. These regulations require a three part regulatory rulemaking process including the publication of an Advanced Notice of Proposed Rulemaking, a Tentative Final Monograph (TFM) or Proposed Rule, and a Final Monograph or Final Rule to establish the conditions under which drugs under the OTC Drug Review are considered GRAS/GRAE and are not misbranded. FDA does not require OTC products conforming to the conditions of a final monograph and other applicable regulations to have approved NDAs prior to marketing. As a corollary, it has also generally been FDA's enforcement approach since the early days of the OTC Drug Review to not pursue regulatory action against OTC products marketed in conformance with the conditions proposed in a TFM. (See Compliance Policy Guide Section 450.200 Drugs—General Provisions and Administrative Procedures for Recognition as Safe and Effective at: http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074388.htm).
Our examination, however, has revealed significant challenges associated with the OTC Drug Review as it functions today. When we look at how rapidly science now evolves and the impact this has had on the emergence of drug safety issues and on drug development, it is clear to us that questions need to be asked about whether this impact necessitates a more agile and responsive process than the OTC Drug Review allows. When the OTC Monograph Process was initially established and implemented in the early 1970s, the multistep rulemaking strategy was thought to be an effective and efficient approach to reviewing large categories of active ingredients in drug products at the same time given what was the current thinking about the known science related to these ingredients. Indeed, the questions we are raising in this notice about the OTC Drug Review become all the more important to the public health when we compare the statutory changes that have been made to update the regulation of prescription NDA drugs to address the scientific advances in evaluating drug safety. These changes give FDA the ability to quickly obtain new information and take administrative action as needed efficiently and effectively.
c. Product Formulation. Under the OTC Drug Review, the monographs set forth the conditions under which a specific active ingredient used in a drug product is GRAS/GRAE and not misbranded. The monographs, however, generally do not dictate what other non-active ingredients can be added, or other aspects of the formulation (other than the general requirement that they be safe and suitable and not interfere with the effectiveness of the preparation, see § 330.1(e)). Thus, under the OTC Drug Review, products in their final formulation are not specifically evaluated by the Agency to ensure product safety, effectiveness, and consistency. Although FDA regulations require that inactive ingredients not interfere with the safety or efficacy of the drug product, for drug products marketed under the OTC Drug Review, FDA generally does not receive information about specific varying formulations that it can use to ensure that the final finished drug products meet the standards for safety and effectiveness.
Eligibility for the OTC Drug Review is limited to active ingredients that were on the market in their specific dosage forms at the inception of the OTC Drug Review, and products that have become eligible under the Time and Extent Application process set forth at § 330.14. Thus, when manufacturers develop new combinations of ingredients or new dosage forms (e.g. dissolving films or tablets), the OTC Drug Review is not facile in accommodating these types of changes. Due to these changes, products that are not eligible for consideration under the OTC Drug Review would otherwise require an NDA prior to marketing.
II. The Future: Modernizing the OTC Drug Review Back to Top
This idea would involve establishing a process similar to that enacted by the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144) for device reclassifications. FDASIA changed the process by which devices are reclassified under section 513(e) of the FD Act from notice and comment rulemaking to an administrative order process (see 21 U.S.C. 360c(e)(1)(A)(i)). Under this model, monographs could be established by administrative order, after issuance of a proposed order for comment.
The OTC Drug Review regulations provide a process for approving a drug product that complies with the conditions of a final monograph except for a deviation (§ 330.11). In this instance, a sponsor can apply for an NDA deviation by submitting an NDA showing that the product complies with the conditions of the monograph except for the deviation and providing the necessary data to demonstrate the safety and effectiveness of the product with the deviation. For example, an OTC monograph may not cover certain dosage forms of a monograph ingredient. The manufacturer of a proposed different dosage form could submit an NDA that relies on the final monograph to demonstrate the safety and efficacy for the drug except for the differences related to the change in dosage form. The NDA would also need to include the appropriate data to demonstrate the safety and effectiveness of the new dosage form. The approved NDA would be specific only to the NDA sponsor and would not amend the monograph.
FDA is holding this public hearing to seek input on possible ways to modernize the OTC Monograph Process in order to make the process more responsive to emerging safety information and scientific advances. We would like feedback from a variety of interested members of the public, including consumers; industry; and pharmacists, physicians, and other members of the medical community. FDA is interested in obtaining information and public comment in the following areas: A. Strengths and Weaknesses of the Existing OTC Drug Review
Participants should submit a copy of each presentation to Mary Gross or Georgiann Ienzi (see FOR FURTHER INFORMATION CONTACT) no later than 5 p.m. on March 12, 2014. We will file the hearing schedule, indicating the order of presentation and the time allotted to each person, with the Division of Dockets Management (see Comments and Transcripts). FDA will post an agenda of the public hearing and other background material at least 3 days before the public hearing and additional information will be available at: http://www.fda.gov/Drugs/NewsEvents/ucm380446.htm (select this hearing from the events list).
Under § 15.30(f), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation (§ 15.30(e)). Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (21 CFR part 10, subpart C) (§ 10.203(a)). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b). (See section VII for more details.) To the extent that the conditions for the hearing as described in this document conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in § 15.30(h).