Welcome to FDA in Flux \u2014 A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.<\/p>\n
The August 2025 edition highlights four significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.<\/p>\n
FDA\u2019s PreCheck Program Seeks to Facilitate Domestic Drug Manufacturing<\/p>\n
What is happening: On August 7 the agency announced<\/a> a new program, called FDA PreCheck, to provide drug manufacturers with earlier and more frequent interaction with FDA on manufacturing facility design and construction. The intent of the program is to accelerate drug company efforts to establish or expand domestic manufacturing operations.<\/p>\n The PreCheck program consists of two phases:<\/p>\n \tThe Facility Readiness Phase gives manufacturers opportunities for FDA feedback during a facility\u2019s \u201ccritical development stages,\u201d which include design, construction, and preproduction stages. It appears that these preoperational reviews duplicate an existing option for industry to request FDA feedback on construction plans (see previous policy here<\/a>). Under PreCheck, the agency will also be encouraging participating manufacturers to submit a Drug Master File containing detailed information about the facility that can then be referenced in product-specific marketing applications. FDA opened a docket<\/a> to accept stakeholder comments on the program (due by October 30, 2025) and scheduled a public meeting<\/a> for September 30, which can be attended either in person or virtually.<\/p>\n Why it matters: FDA\u2019s stated goal is to accelerate onshoring of drug manufacturing by providing facility design guidance and, ultimately, greater regulatory predictability for manufacturers. The program responds in part to President Trump\u2019s executive order<\/a> on reducing regulatory burdens to promote domestic production of critical drugs and biologics, although PreCheck\u2019s impact on achieving that goal is uncertain. Greater agency interaction during the facility design and construction phase could mitigate certain regulatory compliance issues, but the program may stretch the boundaries of FDA\u2019s human resources. As announced, the PreCheck program seems of limited value to manufacturers as the agency does not employ engineering or construction experts, so any FDA investigator feedback on facility-based cGMP matters may not reflect other important considerations. For example, cGMP compliance is highly dependent on actual practices within an operational facility as well as the relevant written policies and procedures, which would not be addressed in PreCheck-related feedback.<\/p>\n With respect to the program\u2019s Application Submission Phase, moreover, additional CMC meetings appear to have little value as drug sponsors currently have multiple opportunities to request CMC meetings with FDA throughout the clinical development process. It also is unclear how a manufacturer that is not the sponsor for drug development and does not plan to submit any future marketing applications \u2014 e.g., contract manufacturing organizations (CMOs) \u2014 would take advantage of the second phase of PreCheck. CMOs presumably could participate in the Facility Readiness Phase, but FDA has not indicated whether a manufacturer could participate in one phase and not the other.<\/p>\n Who may be affected: The FDA PreCheck program will most directly affect drug manufacturers looking to establish or expand operations in the United States, including (presumably) CMOs that produce drugs and biologics for the companies engaged in drug development. Manufacturers designing facilities for specific drug or biological products or supporting supplemental marketing applications to take over manufacturing for already approved products will likely benefit most from the program. It\u2019s also important to keep in mind that designing a manufacturing facility in accordance with FDA\u2019s feedback under the PreCheck program will not insulate the facility from future inspectional observations of noncompliance.<\/p>\n Ultra-Processed Foods in the Spotlight: Federal Agencies Seek to Create a \u201cUniform Definition\u201d Why it matters: Although the science is far from settled and research is still needed to tease out which food ingredients or processes may be underpinning observational study results that link UPFs to poor health outcomes, the May 2025 MAHA Report called out the increasing prevalence of UPFs in American diets as a root cause of high rates of chronic health conditions in children. FDA, HHS, and USDA are building on the report\u2019s conclusions by seeking to more clearly and consistently define UPFs in future \u201cresearch and policy,\u201d with the eventual goal of \u201caddressing health concerns associated with the consumption of UPFs.\u201d The agencies do not mention specific plans for how they might use a consensus definition of UPFs in the future. However, various public policy decisions or future regulatory actions \u2014 such as mandatory labeling requirements \u2014 could stem from a universally recognized UPF definition.<\/p>\n Who may be affected: For years food manufacturers have defended product liability lawsuits alleging that one or more UPFs caused a consumer\u2019s obesity or diabetes, with courts typically dismissing such claims due to the obvious health risks associated with eating high-fat, high-sodium, or high-sugar foods. In short, manufacturers do not have a duty to specifically warn consumers that \u201cjunk food\u201d is not nutritious or could cause chronic health problems when consumed in excess. The lack of a universally accepted UPF definition has also helped defendants in such lawsuits by undercutting certain causation arguments put forward by consumer-plaintiffs. A federally recognized definition for what constitutes a UPF, irrespective of how FDA and its sister agencies ultimately deploy that definition, may have an adverse impact on defense arguments in this flavor of product liability litigation. It may also strengthen more novel theories of liability for nonmanufacturer entities such as retailers or restaurants that sell UPFs to consumers. Given the potential paradigm-shifting nature of federal action in this space, all stakeholders should consider responding to the agencies\u2019 request<\/a> for information and data.<\/p>\n Medical Device User Fee Amendments (MDUFA) Kickoff Meeting Suggests Stability in the Program\u2019s Future<\/p>\n What is happening: FDA held an initial public meeting on August 4 to start the negotiation process for reauthorizing the next five years of MDUFA (FY 2027 \u2013 2032). Despite the many changes at the agency since January, comments by representatives from the agency, industry, physician and hospital associations, and patient advocacy groups were generally positive about FDA\u2019s performance on device programs, and their comments hewed to familiar themes. Key messages coming out of the meeting included:<\/p>\n \tCommissioner Makary\u2019s opening remarks praised Center for Devices and Radiological Health (CDRH) Director Michelle Tarver, noted recent advances in FDA technology (i.e., Elsa, the recently deployed generative AI tool to assist agency staff), and highlighted areas ripe for further modernization. Why it matters: The kickoff meeting provides an initial look at the interests of various stakeholders and what they hope the MDUFA negotiations achieve in terms of FDA commitments and performance goals. Commissioner Makary\u2019s apparent support for Director Tarver and CDRH, as well as Dr. Tarver\u2019s comments spotlighting CDRH\u2019s focus on digitization and adding resources, indicate that FDA\u2019s aim is to keep device programs consistent with existing user fees by supporting incremental improvements. Similarly, industry group representatives generally appear to support the status quo, but will seek further transparency on the agency\u2019s allocation of user fees.<\/p>\n Other participants from physician, hospital, academic, and patient associations put forward familiar arguments about the need to expand FDA oversight of device manufacturer compliance and provide more detailed information about device safety and efficacy (including in comparison to other legally marketed devices). But because these stakeholders do not directly participate in MDUFA negotiations, it is unlikely that such initiatives will be included in the final package that will be sent to Congress in early 2026 for reauthorization next year. Notably, the meeting indicated broad support for FDA\u2019s TAP Pilot, which could foreshadow expansion of the pilot and its eventual transition to a formal CDRH program.<\/p>\n Who may be affected: The MDUFA reauthorization process and eventual amendment package impact all medical device stakeholders, but this meeting is only the first step in a long process of negotiations between FDA and the device industry, as well as consultations with other stakeholders. Early indications are that the agency and industry are mostly aligned on holding the course to produce a relatively simple and straightforward amendment package for the next five-year program period. Such a result will provide additional stability for device manufacturers and industry investors.<\/p>\n Deregulatory Actions Gain Momentum; May Allow FDA Leeway to Promulgate New Regulations in the Future<\/p>\n What is happening: In July, FDA announced<\/a> that it is revoking 52 individual \u201cobsolete and unnecessary\u201d food product standard-of-identity (SOI) regulations. SOI regulations describe in detail what a particular type of food should contain \u2014 or not contain \u2014 and establish other uniform characteristics for the food. Historically, the purpose of an SOI was to protect consumers by ensuring they are not misled or defrauded (see, e.g., this post<\/a> on enforcement of the mayonnaise SOI back in 2015); they also help deter economic adulteration of food by unscrupulous actors. For the past several years, the agency has been working to modernize the SOI program to account for innovations in technology and food processing as part of a broader Nutrition Innovation Strategy<\/a>.<\/p>\n
\n\tThe Application Submission Phase aims to make development and review of the chemistry, manufacturing, and controls (CMC) module of a product\u2019s marketing application more efficient through preapplication meetings and timely feedback.<\/p>\n
What is happening: On the heels of the Make America Healthy Again (MAHA) Commission\u2019s first report, which we highlighted in a previous newsletter<\/a>, FDA, its parent agency the Department of Health and Human Services (HHS), and the US Department of Agriculture (USDA) have jointly issued a request for \u201cdata and information to help develop a uniform definition of ultra-processed foods (UPF or UPFs).\u201d The solicitation<\/a> includes a specific list of questions; responsive comments should be submitted by September 23, 2025.<\/p>\n
\n\tDirector Tarver also spoke about opportunities to modernize agency resources, such as building out capabilities for considering real-world evidence in device submissions. She pointed out the Center\u2019s need for additional personnel, particularly experts who can handle increasingly complex device reviews.
\n\tIndustry representatives from the Medical Device Manufacturers Association and AdvaMed acknowledged FDA\u2019s achievement of recent MDUFA performance goals (the current iteration negotiated to cover FY 2022 \u2013 2027). But they also noted that continued major increases in user fee amounts are unsustainable for manufacturers, especially when there is little information on how FDA uses the collected funds. In general, industry is hoping fees will be used to support frontline reviewers and high-quality (rather than merely fast) reviews.
\n\tRepresentatives from physician, hospital, academic, and patient associations argued that FDA should use collected funds to expand other device programs and resources, such as developing policies on new clinical trial models, enhancing post-market surveillance of devices and direct-to-consumer advertising, and providing more information on device safety and efficacy to patients and providers. These stakeholders urged such improvements be implemented even if industry user fees need to be raised dramatically.
\n\tMost of the meeting participants mentioned and spoke highly of FDA\u2019s Total product life cycle Advisory Program (TAP) Pilot. TAP was created by FDA and industry as part of the last reauthorization cycle to provide early, frequent, and strategic communications to developers of innovative devices to get them to market \u2014 and therefore patients \u2014 more quickly.<\/p>\n