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21 December 202315 minute read

FDA Regulatory News and Trends - December 21, 2023

Welcome to FDA Regulatory News and Trends, designed to help you identify significant legal developments and navigate the evolving business, legal, and regulatory world.

Updated guidance for regulatory meetings with FDA for drugs and biological products.

  • On November 22, 2023, FDA’s Center for Biologics Evaluation and Research (CBER) published an updated Standard Operating Policy and Procedure (SOPP), entitled, “Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products.” CBER previously updated this SOPP in March 2023 to address the post-COVID-19 return to in-person/hybrid meetings and changes related to the 2023 CBER reorganization.

  • Among more general updates, the SOPP includes a new appendix D for additional information regarding CBER’s considerations for granting meetings versus issuing written response only (WRO) responses. 

Draft guidance to support “urinary tract health” claims for adult maintenance cat food.

  • On November 29, 2023, the Center for Veterinary Medicine (CVM) at FDA issued a draft guidance, entitled, “Using Relative Supersaturation to Support 'Urinary Tract Health' Claims for Adult Maintenance Cat Food.” 

  • Relative supersaturation (RSS) is a methodology to support urinary tract health (UTH) labeling for certain adult maintenance cat food. RSS measures estimated potential for crystal formation and bladder stone (urolith) growth, a common affliction in cats.  

  • The guidance provides recommendations for pet food manufacturers on how to use RSS to substantiate relevant labeling. The recommendations include (1) the wording of UTH claims based on RSS methodology for use on adult maintenance cat food labeling, (2) the RSS criteria to substantiate UTH claims, and (3) the study data CVM requests from pet food manufacturers that demonstrate the utility and target animal safety of the cat food.  

  • Interested parties should submit comments on or before February 28, 2024.

Regulators outline more potential benefits of a global pharmaceutical product identifier.

  • In a recent CDER SBIA webinar, FDA touted additional benefits and use cases related to the Identification of Medicinal Products (IDMP). IDMP involves five International Organization for Standardization (ISO) standards intended to facilitate identification and tracing of medicinal products globally through data elements and structures, pharmaceutical product identifiers, substance identification, dosage form and route of administration, and units of measurement.

  • In its March 2023 direct-to-final guidance, FDA suggested that the adoption of these IDMP standards would improve pharmacovigilance, global supply chain integrity, and exchange of medicinal product information. 

  • While the Agency has succeeded in certain efforts to align with ISO standards, FDA continues to collaborate with regulators and standards bodies to resolve remaining issues to eventually achieve a global implementation framework.

  • The November 28 webinar discussed benefits including identification of substandard products as well as the alleviation of drug shortage issues through international sourcing of alternative products in short domestic supply. Further, although rare, the Agency indicated that a Global Pharmaceutical Product Identifier (PhPID) that links similar products in various jurisdictions/languages could facilitate access to replacement prescriptions for international travelers.

CDER deprioritizes unresolved citizen petitions based on periods of inactivity.

  • According to FDA’s response to a citizen petition originally submitted in 2015, CDER intends to reduce the backlog of unresolved citizen petitions through a review of petitions that were submitted over five years ago and that may no longer be considered timely.

  • Specifically, the Agency stated that “having to respond to these old petitions diminishes the Center’s capacity to address in a timely fashion pressing public health issues. Therefore, these petitions have a lower priority[…].”

  • In this particular response, FDA states that, if the petitioner wishes to keep the petition active, that petitioner must respond in kind within 30 days – otherwise, the petition will be “considered to have been voluntarily withdrawn without prejudice to resubmission.”

FDA finalizes rule on DTC drug advertisements concerning “major statement” requirement.

  • On November 21, 2023, FDA published a final rule in the Federal Register that amends its regulations regarding direct-to-consumer drug advertisements for human prescription drugs in TV or radio format. These requirements will go into effect on May 20, 2024, and the compliance date is set for November 20, 2024.

  • This final rule specifies five standards to ensure that the major statement, which provides the side effects and contraindications, is presented in a clear, conspicuous, and neutral manner in TV and radio advertisements.

  • The five standards are as follows:

    1. Information must be presented in language that is readily understandable by consumers

    2. Audio information must be understandable in terms of volume, articulation, and pacing used

    3. For ads in TV format, the major statement must be presented concurrently using both audio and text (ie, dual modality)

    4. Textual information must be placed appropriately and be presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily, and

    5. The advertisement must not include distracting elements (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.

FDA withdraws from the Global Harmonization Working Party.

  • On November 27, 2023, FDA announced that it had withdrawn as a member of the Global Harmonization Working Party (GHWP), which focuses on harmonizing medical device regulations globally. FDA had been a member of the group since December 2021.

  • FDA stated several reasons for leaving the group, such as lack of leadership that is representative of a global perspective, imbalance of regulator and industry participation, lack of transparency in the document creation process, and potential duplication of efforts from other harmonization groups.

  • FDA also made clear that it is continuing its involvement in the International Medical Device Regulators Forum (IMDRF), a separate group which is also focused on international harmonization of device regulations: "In 2024, FDA, as chair of IMDRF, will continue to work collaboratively to reach consensus on common goals, foster global regulatory convergence, and leverage resources to make safe and effective medical devices available globally."

Proposal to reclassify certain wound dressing and liquid wound washes based on antimicrobial characteristics.

  • FDA recently published a proposed rule that, if enacted, would reclassify certain wound dressing and liquid wound washes based on their antimicrobial characteristics.

  • Wound care devices reviewed by CDRH encompass all risk classes – I (low-risk), II (moderate-risk), and III (high-risk) – depending on intended use and materials. At a high level, the recently proposed rule splits regulation of wound dressings and washes into either Class II or Class III depending on whether they use or contain “medically important antimicrobials.” 

  • To be included under the proposed rule, the antimicrobials in question must be either preservatives or protectants. Notably, the proposal would classify some currently unclassified wound care devices and would additionally allow some products currently regulated as combination products to be regulated as medical devices. 

  • FDA also issued a proposed order outlining a tiered pre-market submission timeline based on the proposed rule.

  • The proposed rule and associated order are open for comment through February 28, 2024. A Medical Device Advisory Committee meeting will likely consider the proposals before they are finalized.

Small-entity compliance guidance for milk and cream products and yogurt products.

  • In November 2023, FDA announced the availability of a Small Entity Compliance Guide to help food manufacturers producing yogurt products for the US market comply with the Agency’s “Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt.”

  • Published in June 2021, and modified in December 2022 and April 2023, the Final Rule revoked the Standard of Identity (SOI) for lowfat yogurt and nonfat yogurt and modernized the SOI for yogurt, allowing for new ingredients and manufacturing methods. Under the November 2023 guidance, lowfat yogurt and nonfat yogurt must comply with the general definition and SOI in 21 C.F.R. 130.10 for foods deviating from standardized foods due to compliance with a nutrient content claim.

  • The guidance outlines the scope of FDA’s changes to the SOI for yogurt, addresses required and optional ingredients to produce yogurt as well as minimum dairy requirements, discusses other yogurt specifications including the requirements for milkfat and milk solids-not-fat and yogurt pH, clarifies the requirements around optional ingredients such as sweeteners, and details labeling and naming requirements.

  • Manufacturers must comply with the rule for products labeled on or after January 1, 2024.

Bumpus promoted to FDA's second-highest leadership role.

  • On November 29, 2023, FDA Commissioner Dr. Robert Califf announced that the Agency’s chief scientist Dr. Namandjé Bumpus had been selected as FDA’s next Principal Deputy Commissioner. Dr. Bumpus, a pharmacology doctorate specializing in HIV research, will replace Dr. Janet Woodcock upon her retirement in early 2024.

  • As FDA’s second in command, Dr. Bumpus will work with Agency leadership to develop public health initiatives, oversee FDA's daily activities, and create an updated model for the Agency's Office of Regulatory Affairs, Dr. Califf said in a statement.

  • Dr. Bumpus, credited as a “a champion of plain language” in public health communication by Dr. Califf, will also work on the organization of the unified Human Foods Program alongside James “Jim” Jones, who joined the Agency as the first Deputy Commissioner for Human Foods in September.

FDA provides additional information to help industry comply with the Food Traceability Rule.

  • FDA recently updated its website to include additional Frequently Asked Questions and other tools to assist industry as they prepare to comply with the Food Traceability Rule issued pursuant to the FDA Food Safety Modernization Act. The Food Traceability Rule established additional recordkeeping requirements for manufacturers, processors, packers, and holders of foods on the Food Traceability List.  Entities subject to the rule will have to establish, maintain, and share key data elements through the supply chain that will facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. FDA has authority to request data from industry in the event of an outbreak or other food safety event.

  • The additional tools supplied by FDA include: 
    • A new webpage with information regarding traceability lot codes, including examples of how Key Data Elements (KDEs) could appear on invoices and bills of lading

    • A video highlighting certain technological components of product tracing systems

    • Examples of a traceability plan

    • New Frequently Asked Questions

    • New supply chain examples for deli salads

    • Information on how to apply for a waiver or exemption, if eligible

  • The compliance date for this rule is January 20,2026, but industry is encouraged to start preparing now in order to meet this deadline.  Preparation should include understanding if and how the rule affects your business; understanding what and how data is currently kept; conducting a gap analysis with new regulatory requirements; discussing the rule with supply chain partners to determine how data will be shared; implementing any needed technology solutions; and perhaps changing supply chain contracts, if applicable.

  • While the new tools may prove useful, confusion still exists around the rule requirements.  FDA has been requested to provide additional information, particularly around traceability lot codes, distribution centers, and examples of data requests from the Agency.

FDA, USDA, and EPA propose national strategy to reduce US food loss and waste.

  • FDA, USDA, and EPA released "Draft National Strategy for Reducing Food Loss and Waste and Recycling Organics." The goal of the strategy is to prevent the loss and waste of food and increase recycling of organic materials, reduce greenhouse gas emissions, save households and businesses money, and build cleaner communities.   

  • This draft strategy has four main objectives:

    • Objective 1: Prevent the loss of food where possible.

    • Objective 2: Prevent the waste of food where possible.

    • Objective 3: Increase the recycling rate for all organic waste.

    • Objective 4: Support policies that incentivize and encourage food loss and waste prevention and organics recycling.

  • The agencies are seeking comment from stakeholders on all aspects of the draft strategy but are encouraging input on the following key questions:

    • What actions could help the US meet its goals that are not reflected in the draft?

    • What type of research should be funded?

    • What actions would result in more equitable outcomes for underserved and/or food insecure communities?

    • The comment period will be open through January 4, 2024.