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20 January 20239 minute read

FDA Regulatory News and Trends

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

FDA guidance encourages clearer, more informative REMS documents using the Structured Product Labeling (SPL) format. The agency recently published Format and Content of a REMS Document, Guidance for Industry, guidance which provides NDA, ANDA, and BLA holders with recommendations for drafting proposed Risk Evaluation and Mitigation Strategy (REMS) documents and converting already-approved REMS to a new, standardized format. The guidance document can be used in conjunction with a separate guide, REMS Document Technical Conformance Guide, which provides more specific and more regularly updated information for drafting REMS documents. FDA explains that since implementing REMS nearly 15 years ago, the agency has received feedback from industry and other stakeholders regarding the format of REMS. Furthermore, the guidance seeks to align REMS documents with international SPL format standards. FDA already accepts or requires SPL standards for a number of submissions, and this alignment should improve the exchange of REMS information between manufacturers, the agency, prescribers, and other stakeholders. The guidance document provides applicants with appropriate sections and headings that should be included in each submission and describes what information must be included in each section. The document also describes procedures for REMS submissions and outlines what supporting materials are needed and when they should be provided.

Potential tradeoffs in consumer understanding of drug risks and benefits in online character space limited promotion. In FDA’s 2014 draft guidance Internet/Social Media Platforms with Character Space Limitations –Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, the agency took the position that drug manufacturers choosing to make a product benefit claim should also incorporate risk information within the same character space limited (CSL) communication. Some stakeholders subsequently suggested that risk information in CSL communications could be sufficiently conveyed by including a link from the benefit information. To address this question, researchers in the Office of Prescription Drug Promotion (OPDP) studied the effects of  including substantive risk information in the CSL communication itself versus only providing a link to risk information, and including both risks and benefits versus describing only risks on the landing page to which the promotional communication links. A review of the study, completed last month, found that relatively few people click a link to read additional information about a drug product, making a case for the inclusion of critical risk information in the advertisement itself. These results provide a first look at the tradeoffs involved in promoting drugs using online CSL communications.

Federal Trade Commission issues Health Products Compliance Guidance, which replaces the 1998 Dietary Supplements: An Advertising Guide for Industry. This updated guidance applies to express and implied claims made in the marketing of any health-related product, including foods, over-the-counter (OTC) drugs, homeopathic products, health equipment, diagnostic tests, and health-related apps. This guidance elaborates on the meaning of “competent and reliable scientific evidence” which is the evidentiary standard for substantiating health-related claims. The guidance also discusses the agency’s thinking around consumer testimonials, expert endorsements, and disclosures of qualifying information.  For a more detailed analysis, see DLA Piper’s article, available here

Updates to Government Tools to Help Digital Health Product Developers Understand Legal Requirements. On December 7, 2022, the Federal Trade Commission (“FTC”), the US Department of Health and Human Services and the FDA announced updates to the Mobile Health App Interactive Tool found on FTC’s website. This interactive tool, comprised of a series of questions, is designed to help mobile health app developers identify federal regulatory, privacy and security laws and regulations that may apply to their products. The recent update adds new questions to the tool to help app developers understand legal requirements under the Children’s Online Privacy Protection Rule and the 21st Century Cures Act. This tool’s webpage states that it is not offering legal advice and is provided for informational purposes only. In addition, on December 15, 2022, FDA announced updates to its Digital Health Policy Navigator. This tool is intended to be a user-friendly resource to help product developers understand whether a software function is potentially the focus of the FDA's regulatory oversight as a device. The tool aggregates FDA's device digital health guidance documents, organizing concepts from those guidances into seven steps, each with a set of questions. The Digital Health Policy Navigator was first published on September 28, 2022 – the same day FDA finalized Clinical Decision Support (CDS) Software guidance – and the recent update incorporates additional details from the final CDS guidance into the tool. The tool can be useful for getting a feel for whether a software function might be regulated as a medical device or not, and for identifying the most relevant laws, guidances, or policies to consider, but FDA is clear that the tool’s results are not a formal FDA device determination for a product.

FDA allows retail pharmacies to dispense the abortion drug Mifeprex (mifepristone) and its generic version. On January 3, 2023, FDA modified mifepristone’s Risk Evaluation and Mitigation Strategy (REMS), removing the requirement that prohibits retail pharmacies from dispensing the drug, including its generic version. Under the modified REMS, mifepristone can be dispensed by “certified pharmacies on prescriptions issued by certified prescribers,” where “any pharmacy that meets the requirements of the Mifepristone REMS Program is eligible for certification.” The January 2023 modification is the second REMS modification in recent years to relax the restricted access to mifepristone. On December 16, 2021, the agency removed the in-person requirement, allowing telemedicine prescription and mail delivery of mifepristone by a certified pharmacy. It is unclear whether states with “near-total abortion” can benefit from this update. To address this uncertainty, the US Department of Justice issued a 21-page opinion, concluding that the Comstock Act does not prohibit the mailing of Mifepristone, regardless of state law. Both modifications arose from the agency’s review of the Mifepristone REMS Program where the FDA determined that “the available data and information support modification of the REMS to reduce burden on the health care delivery system and to ensure the benefits of the product outweigh the risks.” In addition to the REMS modification, FDA launched a new webpage, Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation, providing much-needed clarity on mifepristone REMS program and legal issues related to mifepristone.

FDA updates its Recognized Consensus Standards database for medical devices, including eight digital health-related standards. While the full list spans specialties from anesthesiology to dental to in vitro diagnostics, last month’s changes, referred to as “List 59,” include one new standard, three revised standards, two extended transition periods, as well as several digital health-related consensus standards dealing with cybersecurity, interoperability, and artificial intelligence. Specifically, IEEE Std 2621.2-2022 describes the security functional requirements of protection profiles for connected diabetes devices, while IEC 81001-5-1 Edition 1.0 2021-12 defines life cycle requirements for developing and maintaining certain health software. In addition, the listed ANSI NEMA standard is intended to assist professionals responsible for executing security risk assessments in their management of medical device security capabilities. With respect to interoperability, the ANSI AAMI UL standards specify baseline sets of risk concerns, and development and integration lifecycle requirements, for safe and secure interoperability of medical systems. Lastly, AAMI CR34971:2022 provides guidance for applying an ISO risk management process when evaluating medical technology using machine learning throughout all phases of the product lifecycle. See the FDA’s Recognized Consensus Standards database for the complete list, including standards on biological evaluation of medical devices, syringes with re-use prevention features, and more.

FDA releases new draft guidance on delaying, denying, or limiting inspections.  On December 15, 2022, FDA released a new draft guidance titled, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection.  Once finalized, this draft guidance is intended to supersede the October 2014 final guidance limited to drug inspections, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.  The draft guidance reflects the FDA Reauthorization Act of 2017, which was signed into law on August 18, 2017 and deems both drugs and devices to be adulterated if they have been “manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.”  In addition to expanding examples from the 2014 guidance to also apply to device facilities, the new draft guidance provides updates that reflect the modernization of today’s facilities, for example, by noting that removing data or locking electronic records so that data cannot be searched or analyzed would be considered limiting access to records, that a reasonable explanation to a delay in accessing records includes that the records are stored off-site, and that if photography of raw materials would adversely affect product quality, limiting such photography may be reasonable.  The draft guidance provides a new example specifying that if a facility agreed to a pre-announced inspection date, but necessary personnel are unavailable or operations are down on the agreed upon date, this would be considered delay during an inspection.  The draft guidance also adds a new sentence, “FDA will consider reasonable explanations for behavior that may otherwise be considered to be delaying, denying, limiting or refusing an inspection.”  Comments on the draft guidance are due February 14, 2023.