Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations: 1) <a href="https://www.fda.gov/media/155038/download" target="_blank">Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency</a> (the “Enforcement Policy Transition Guidance”) and 2) <a href="https://www.fda.gov/media/155039/download" target="_blank">Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)</a> (the “EUA Transition Guidance”), both dated March 27, 2023. These final guidance documents finalize the corresponding draft guidances issued on December 23, 2021, and both set out a 180-day transition period.Enforcement Policy Transition GuidanceThe 180-day transition period under the Enforcement Policy Transition Guidance will start on the “implementation date,” which will be May 11, 2023, unless the PHE declaration is renewed another time contrary to the <a href="https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf" target="_blank">Administration’s current plan</a>. The Enforcement Policy Transition Guidance applies to devices that fall under 15 FDA COVID-19 enforcement policies, where FDA has indicated that it does not intend to object to certain modifications or distribution of certain devices in the following categories:<ol><li>remote digital pathology devices;</li><li>imaging systems;</li><li>non-invasive fetal and maternal monitoring devices;</li><li>telethermographic systems;</li><li>digital health devices for treating psychiatric disorders;</li><li>extracorporeal membrane oxygenation and cardiopulmonary bypass devices;</li><li>remote ophthalmic assessment and monitoring devices;</li><li>infusion pumps and accessories;</li><li>face shields, surgical masks, and respirators;</li><li>gowns, other apparel, and gloves;</li><li>sterilizers, disinfectant devices, and air purifiers;</li><li>ventilators and accessories and other respiratory devices;</li><li>FDA-cleared molecular influenza and RSV tests;</li><li>coagulation systems; and</li><li>viral transport media.</li></ol>These policies are all currently set to expire on November 7, 2023, which is 180 days after May 11, 2023.The Enforcement Policy Transition Guidance sets out three phases: Phase 1 (first 90 days after the implementation date—expected to be from May 11 to August 8, 2023); Phase 2 (the second 90 days after the implementation date—expected to be from August 9 to November 6, 2023); and Phase 3 (180 days after the implementation date—expected to begin on November 7, 2023). In the Enforcement Policy Transition Guidance, FDA provides phase‑by‑phase compliance guidance for manufacturers of a device that falls under any of the FDA COVID-19 enforcement policies mentioned above. It is important to note that some of the guidance applies to manufacturers regardless of whether they intend to continue distribution of the device after a certain phase. For example, manufacturers should send a notification of intent to FDA regardless of whether they intend to continue distribution of their device after Phase 2.EUA Transition GuidanceThe 180-day transition period under the EUA Transition Guidance, on the other hand, will start when the corresponding EUA declaration terminates (the “EUA termination date”). The EUA Transition Guidance applies to devices that are authorized under any of the EUA declarations related to COVID-19 such as the <a href="https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency" target="_blank">EUA declaration for COVID-19 in vitro diagnostics</a> (the “EUA devices”). As FDA explains in the guidance, an EUA declaration is not dependent on the PHE declaration, which means that the 180-day transition period for the EUA devices may start well after the PHE declaration expires, that is, possibly well after May 11, 2023.The EUA Transition Guidance requests manufacturers of the EUA devices that FDA deems to be “reusable life-supporting or life-sustaining” to submit a letter of intent to FDA as soon as possible, regardless of their intent to continue distribution of the device after the EUA termination date. Note that this request is effective as of March 27, 2023, and manufacturers should not wait until the transition period or the EUA termination date to submit the intent letter. Section A of the guidance provides the details including the product codes relevant to this request and the information to include in the letter.The EUA Transition Guidance also provides recommendations and policies for manufacturers seeking a full marketing authorization for a device related to any of their EUA devices. The guidance indicates that FDA does not intend to object to continued distribution of the EUA device after the EUA termination date, if (i) the manufacturer submits a marketing submission for a candidate device that is the same as, derivative of, or next generation of the EUA device, (ii) FDA formally accepts the marketing submission before the EUA termination date, and (iii) FDA has not taken a final action on the marketing submission. Since FDA’s formal acceptance of the marketing submission could be delayed due to various reasons, including administrative incompleteness of the submission, manufacturers are advised to submit well before the EUA termination date.FlexibilitiesNotably, both guidance documents indicate FDA’s willingness to be flexible in certain areas. For example, the guidance documents indicate that real-world data from the actual use of the device during the COVID-19 pandemic may be included in the marketing submission. Both guidance documents also recommend manufacturers to engage with FDA early in the transition period to discuss extenuating circumstances such as an ongoing clinical study that makes it difficult to meet certain deadlines provided in the guidance. Further, both guidance documents acknowledge that there may be unique quality system compliance considerations for certain manufacturers and suggest requesting an exemption or variance from a device quality system requirement within the first 90 days of each transition period.Finalization of these guidances does not necessarily mean that the COVID-19 EUA declarations will be terminated soon or that FDA will soon cease accepting and reviewing new EUA requests. At the same time, however, it certainly gets us closer to such transitions. This is an important development, and manufacturers who have distributed devices under an EUA or under one of these enforcement discretion policies during the pandemic should seek the advice of counsel to ensure compliance with the transition.

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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FDA Issues Final Transition Guidances for COVID-19 Devices

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This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations:

FDA Issues Final Transition Guidances for COVID-19 Devices

On Thursday, March 23, 2023, the Food and Drug Administration (FDA) <a href="https://www.federalregister.gov/documents/2023/03/24/2023-06066/framework-for-the-use-of-digital-health-technologies-in-drug-and-biological-product-development" target="_blank">announced</a> the publication of the “<a href="https://www.fda.gov/media/166396/download" target="_blank">Framework for the Use of Digital Health Technologies in Drug and Biological Product Development</a>” (Framework) by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The publication of this digital health technology (DHT) framework fulfills an FDA commitment under the seventh iteration of the Prescription Drug User Fee Act reauthorization (PDUFA VII).What Are DHTs?In the context of the Framework, DHTs are “systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses.” This includes technologies intended for use as a medical product, in a medical product, or as an adjunct to other medical products (i.e., drugs, devices and biologics). DHTs can be in the form of hardware (e.g., sensors for recording of physiological and/or behavioral data), software (e.g., mobile phone, smart watch), or a combination of both hardware and software (e.g., continuous glucose monitoring device with sensor and mobile application). DHTs may be used to support more efficient drug development and uses include increasing decentralization of trial-related activities (e.g., promoting increased trial diversity and retention of study participants), facilitating direct collection of information from patients, and allowing for development of novel endpoints that can help paint a more detailed picture of how participants feel and function in their daily lives.The Framework describes the multifaceted approach FDA intends to use to address how DHTs can be used to support drug development and regulatory decision-making, including workshops and demonstration projects, stakeholder engagement, establishment of internal processes to support evaluation of DHTs for use in drug development, and publication of guidance documents. The Framework itself is “not a guidance document and does not propose or establish policies.”Some of the significant issues addressed in the framework include:DHT Steering Committee – FDA established the DHT Steering Committee to develop internal programs to build review capacity and expertise and to ensure consistent review policies for the use of DHTs in drug development. The Committee has overseen the design of the Framework, and consists of senior staff from CDER, CBER, and the Center for Devices and Radiological Health, as well as the Oncology Center of Excellence and the Office of Clinical Policy and Programs. Committee activities will include:<ul><li>Gathering information on the present state of DHTs</li><li>Making policy recommendations on the use and evaluation of DHT-based measurements in drug development</li><li>Overseeing and coordinating DHT-related drug development working groups</li><li>Engaging with external stakeholders on DHT-related issues in drug development</li></ul>Technical Expertise and Training – FDA will “build on its technical expertise and develop training within the human drugs and biological products programs to enhance internal knowledge regarding the use of DHTs in drug development.” Areas of focus include: verification and validation, use of a participant’s own DHT or general-purpose computing platform, upgrades and updates of DHTs in drug development, artificial intelligence and machine learning, and technical consultation of experts and staff training.Consistency of Evaluations Across Review Divisions – “A single DHT measurement may be used for studies of different diseases and different drugs.” Review divisions and centers in the FDA should have consistent approaches to the review and evaluation of submissions that contain DHT-related data, and the Steering Committee is tasked with facilitating consistent approaches.Statistical Considerations in the Analysis of DHT-Derived Data – The use of DHT-derived endpoints presents “unique statistical considerations” for FDA related to data quality, technical data specifications, provenance, techniques, and algorithms used for processing, summarizing, and analyzing DHT data, and treatment of missing data during its reviews. Existing and novel statistical methods of validation of DHT-derived data must be assessed, and FDA states it will “consider developing technical data specifications to facilitate submission of readily analyzable DHT-derived data supporting drug development.” IT Capabilities – FDA anticipates “new challenges” with the “ability to receive and analyze large DHT-generated datasets to support a regulatory decision.” FDA will enhance its IT capabilities to support the review of such, including development of internal systems to monitor trends in submissions containing DHT-related data and establishment of a secure cloud technology to enhance infrastructure and analytics. After establishing the cloud, FDA will pilot a secure, cloud-based mechanism to support submission and review of DHT-generated datasets.FDA Meetings with Sponsors – FDA engagement with sponsors regarding the use of DHTs may occur at different stages of drug development, including pre-submission meetings, pre-IND meetings, IND and NDA review meetings, and other meetings and communications.Drug Development Tool Qualification Program – “FDA has qualification programs that are intended to support the development of tools for use in assessing medical products and that provide another avenue for sponsors and other stakeholders to engage with the Agency.” DHT developers may choose to pursue qualification of DHTs as drug development tools for a specific use, and a qualified DHT may be relied upon in multiple clinical investigations to support premarket drug submissions where the context of use is the same without having to repeat studies to support qualification.Guidance – To facilitate the appropriate use of DHTs in drug development, FDA has published various draft guidances, including the following:<ul><li><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations" target="_blank">Digital Health Technologies for Remote Data Acquisition in Clinical Investigations</a> (Dec. 2021)</li><li><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-systems-electronic-records-and-electronic-signatures-clinical-investigations-questions" target="_blank">Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers</a> (Mar. 2023)</li></ul>FDA plans to develop additional guidance in identified areas of need informed by stakeholder engagement and plans to publish the following draft guidance in 2023:<ul><li>Decentralized Clinical Trials for Drugs, Biological Products, and Devices (planned for 2023)</li><li>Regulatory Considerations for Prescription Drug Use-Related Software (planned for publication by end of 2023)</li></ul>Public Meetings – By Q2 2023 FDA will convene the first of a series of five public meetings or workshops with key stakeholders to gather input on issues related to the use of DHTs in regulatory decision-making for drug and biological product development. The first meeting is March 28–29, 2023 on <a href="https://duke.is/pzkwx" target="_blank">Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review</a>. Other meetings will be designed to address the following topics:<ul><li>Identifying approaches to DHT verification and validation</li><li>Understanding DHT data processing and analysis to inform the need for novel analytical techniques</li><li>Addressing the regulatory acceptance of safety monitoring tools that utilize AI/ML-based algorithms for pharmacovigilance purposes</li><li>Understanding emerging issues</li></ul>Demonstration Projects – “FDA will identify at least 3 issue-focused demonstration projects to inform methodologies for efficient DHT evaluation in drug development.” These projects may involve engagement with researchers, patient groups, and other stakeholders and will cover key issues to inform regulatory policy development and provide regulatory advice.External Organizations – FDA has participated in several forums addressing the use of DHTs in drug development and will continue to engage with external organizations to facilitate meeting the objectives discussed above.<a href="https://www.regulations.gov/docket/FDA-2022-N-3319" target="_blank">Comments on the Framework</a> must be submitted by May 23, 2023. MoFo is continuously monitoring these developments. Please reach out to MoFo’s FDA + Healthcare Regulatory and Compliance practice for a more detailed analysis and discussion of the implications of these developments.

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FDA Publishes Digital Health Technology Framework

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On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). 

FDA Publishes Digital Health Technology Framework

Update 5/1/2023: FDA is reopening the comment period on the draft guidance published February 23, 2023 (88 FR 11449); the new deadline for comments is July 31, 2023.In 2018, when former FDA Commissioner Scott Gottlieb famously commented that “an almond doesn’t lactate,” he was adding perhaps the most colorful volley in a long-simmering debate about how the Food and Drug Administration (FDA) should regulate the labeling of plant-based milk alternative (PBMA) products. In February 2023, nearly five years later, FDA finally announced <a href="https://www.fda.gov/media/165420/download" target="_blank">draft guidance</a> relating to the naming and voluntary nutrient statements of PBMA products. [1]This new draft guidance is meant to address criticism from both sides of industry about the lack of clarity from FDA regarding the labeling of PBMAs. FDA’s draft guidance was informed by a September 2018 Request for Information on plant-based dairy product labeling that elicited over 13,000 public comments, as well as research demonstrating that, while most consumers understand PBMAs do not contain milk, they are generally less informed about the nutritional differences between milk and its plant-based alternatives.The draft guidance proposed clarifications on several issues that have been the subject of substantial industry debate. There is no “standard of identity” for plant-based milk alternatives in federal law, so plant-based milks must bear the common or usual name of the food. The draft guidance acknowledges that, for many plant-based milks, the common or usual name of the product includes the word “milk.” If finalized, the draft guidance would clarify that, while a standard of identity has been established for milk, that standard of identity does not preclude another food from using “milk” in the label. However, the use must not be misleading, and FDA proposed several recommendations to ensure plant-based milk product labels are not misleading, including the following:<ul><li>PBMAs that include “milk” in the product name should include a qualifying word naming the plant source of the product (e.g., “soy milk”). When multiple plant sources are used, the guidance recommends that both sources be used in the name or the statement of identity, with the most predominant source included first (e.g., “walnut and cashew milk” or “soy and nut milk blend”).</li><li>Names that qualify the terms “beverage” or “drink” with the plant source of the food would also be okay.</li><li>The name not merely should say “plant-based milk/beverage/drink,” but should identify the plant source.</li></ul>FDA’s draft guidance, if finalized, would also settle another debate among stakeholders by clarifying that PBMAs do not need to use the term “imitation” in their labeling. While the draft guidance acknowledged that some plant-based milk alternatives may meet the FDA definition for an “imitation” milk product, the guidance does not recommend labeling such products as “imitation,” and said FDA would not take action against them as being misbranded.In addition, the draft guidance recommended that products that have a different nutritional composition than milk bear what FDA called “voluntary nutrient statements,” i.e., an additional statement on the label describing how the nutrient content differs from milk. FDA based this draft recommendation on research showing that consumers may not understand the nutritional differences between PBMAs and milk, and what FDA described as “the potential public health concern of underconsumption of certain nutrients otherwise provided by milk.” FDA’s draft recommendations include the following:<ul><li>The statement should communicate clearly to consumers when a PBMA is lower in nutrients in comparison to milk. For example, a PBMA label could read “Contains lower amounts of [nutrient name(s)] than milk.”</li><li>For any nutrient listed in USDA’s Food and Nutrition Service non-dairy beverages criteria that is lower in the PBMA product, the label bears the voluntary nutrient statement.</li><li>The voluntary nutrient statement should appear on the principal display panel near and visually connected to the product, if space allows, and the draft guidance provides several visual examples of disclaimers on product containers.</li><li>PBMAs may also make truthful and not misleading statements about nutrients that are not in the nutrient criteria list or that appear in higher amounts than the nutrient criteria list. For example, a PBMA label could read “Contains 50% more calcium than milk.”</li><li>Voluntary nutrient content statements are recommended for products called “beverage” or “drink” and not just for products that use “milk” in the name.</li></ul>The draft guidance goes to great pains to call the recommended nutrient statements “voluntary,” whereas in a guidance like this FDA would typically be providing clarifications as to what statements it considers necessary to avoid FDA considering the product misbranded. FDA may be concerned about the First Amendment implications of treating these statements as required. Nonetheless, we recommend clients seek counsel before deciding not to include a voluntary nutrient statement.Moreover, while the disclosures are “voluntary,” plaintiff’s counsel is likely to be monitoring whether companies are adding them and may challenge the failure to do so through consumer protection claims. Recent litigation has focused on whether reasonable consumers would be deceived when plant-based alternative products use names commonly associated with dairy and meat products. For example, in 2018, the Ninth Circuit ruled that Blue Diamond’s almond milk products were not in violation of False Advertising Law (FAL) in part because the defendant “accurately labels and advertises its almond milk product.” Painter v. Blue Diamond Growers, 757 F. App’x 517, 518 (9th Cir. 2018). Moreover, several cases have extended First Amendment protections to plant-based alternative products that use names commonly associated with dairy or meat products. SeeTurtle Island Foods v. Strain, 594 F. Supp. 3d 692 (M.D. La. 2022) (finding no evidence that Louisiana’s plant-based labeling limitations were necessary to prevent consumer confusion, and the state failed to address why a less restrictive alternative, such as a disclaimer, would not be sufficient to advance the government interest); Ocheesee Creamery LLC v. Putnam, 851 F.3d 1228 (11th Cir. 2017) (although “a state can propose a definition for a given term, . . . it does not follow that once a state has done so, any use of the term inconsistent with the state’s preferred definition is inherently misleading,” particularly where that definition is inconsistent with common usage).The recommendations in the draft guidance are made as the PBMA industry continues to grow, with sales reaching approximately $2.4 billion in 2020 and plant source variety continuing to diversify the marketplace. FDA is still soliciting and reviewing comments on the guidance, and its recommendations will not represent FDA’s views until finalized.We are also watching how Congress reacts to this draft guidance. FDA has already received substantial congressional interest in the guidance, including the introduction of legislation by Sens. Tammy Baldwin (D-WI), Jim Risch (R-ID), Susan Collins (R-ME), and Peter Welch (D-VT) to prevent PBMAs from using the term “milk” in their labeling. There is a long history of congressional action on behalf of food and agriculture constituencies, including actions to prevent the launch of a GE salmon product and added sugar disclosures.Morrison Foerster will continue to monitor the FDA’s guidance on PBMAs. Our regulatory and class action litigation teams work seamlessly to advise clients on product labeling and advertising decisions.Annel Becerra Rodriguez, an associate in our San Francisco office, contributed to the writing of this post.[1] The draft guidance applies only to alternative milk products and not other plant-based dairy alternatives such as cheese, yogurt, or kefir alternatives.

In re Lumber Liquidators Chinese Laminate Litigation

Maxus Energy Corporation

In re Hydroxycut Personal Injury and Class Action Litigation

Los Angeles World Airport (LAWA)

Environmental Law Foundation v. Beech-Nut Nutrition Corp., et al

Fitbit Force Recall 

People of the State of California v. The Coca-Cola Company

Seagate Technology LLC

Clif Bar, Inc.

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Drawing on his considerable experience in environmental health, William (Bill) focuses his practice on environmental and consumer protection law, with an emphasis on climate-related goals and claims, hazardous substances, mass torts, and consumer product safety.

William Tarantino

Drawing on his considerable experience in environmental health, William (Bill) focuses his practice on environmental and consumer protection law, with an emphasis on hazardous substances, mass torts, and consumer product safety.

William F. Tarantino

Nature's Path Foods

Suja Juices

Unilever USA Inc.

Nature’s Path Foods and Sprouts Farmers Market

Iovate Health Sciences, International

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Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy mat

Claudia Vetesi

Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class actions.

Claudia M. Vetesi

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FDA Releases Draft Guidance for Labeling of Plant-Based Milk Alternatives

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In 2018, when former FDA Commissioner Scott Gottlieb famously commented that “an almond doesn’t lactate,” he was adding perhaps the most colorful volley in a long-simmering debate about how the Food and Drug Administration (FDA) should regulate the labeling of plant-based milk alternative (PBMA) products. In February 2023, nearly five years later, FDA finally announced draft guidance relating to the naming and voluntary nutrient statements of PBMA products.

FDA Releases Draft Guidance for Labeling of Plant-Based Milk Alternatives

On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2023.080.01.0024.01.ENG&toc=OJ%3AL%3A2023%3A080%3ATOC" target="_blank">Regulation (EU) 2023/607</a> (the “Regulation”) was published in the Official Journal of the European Union. The Regulation provides for highly anticipated extensions of the transition periods under the <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745" target="_blank">EU Medical Device Regulation</a> (MDR) and certain related provisions under the <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746" target="_blank">EU In Vitro Diagnostic Medical Device Regulation</a> (IVDR).The key elements of the Regulation are:<ul><li>An extension of the validity of certificates (MDR),</li><li>An extension of the transition period (MDR), and</li><li>The removal of time restrictions for sales (the “sell-off” periods) (MDR and IVDR).</li></ul>The Regulation is based on the European Commission’s proposal released on January 6, 2023 (the “Proposal”), which was adopted by the European Parliament and the Council on February 16, 2023. This article provides a brief overview of the above-mentioned key elements of the Regulation. As the text of the Regulation has not changed from the Proposal during the legislative process, we refer to our <a href="https://lifesciences.mofo.com/topics/eu-mdr-and-ivdr-implementation-european-commission-publishes-full-proposal-for-amending-transitional-regime" target="_blank">recent article</a> for a more detailed analysis of the content of the Regulation. It should also be noted that the Regulation’s amendments to the IVDR are limited to the abolition of the sell-off period. The rest of the IVDR’s transitional regime remains untouched. We discussed the IVDR transitional periods in this <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-2-of-3.html" target="_blank">article</a>.Extension of the transition periodThe Regulation amends the transition periods provided for in Article 120 of the MDR. The extension is gradual and depends on the risk class of the device. The transition period is extended from May 26, 2024 to December 31, 2027 for higher risk devices (e.g., Class III and Class IIb implantable devices, except certain devices exempted by the MDR) and to December 31, 2028 for medium- and low-risk devices (e.g., other Class IIb devices, Class IIa devices, and Class I devices placed on the market in sterile condition or with a measuring function).To ensure that only safe devices are placed on the market, the extension of the transition periods requires that certain conditions must be met:<ol><li>The devices must continue to comply with the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AMDD);</li><li>There are no significant changes to the design and intended purpose;</li><li>The devices do not present an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the public health protection; and</li><li>By May 26, 2024 at the latest,</li></ol>Extension of the validity of certificatesThe validity of certificates previously issued under the MDD, which are valid on the date of application of the MDR (May 26, 2021) and have not been withdrawn by a notified body, will remain valid for the duration of the proposed extended transition period of the respective risk class applicable to the device as set out above, provided that the conditions above are met.However, the Regulation does not address the formalities of an extended certificate. It is therefore unclear at this stage whether a new certificate or an amended certificate will be issued in the event of an extension, or on what other basis manufacturers can demonstrate that an otherwise expired certificate is in fact still valid. Manufacturers should watch out for forthcoming Q&A guidance documents addressing this issue.Removal of the sell-off periodsThe sell-off date requirement does not appear in the MDR and the IVDR. Therefore, devices placed on the market before the respective end of the transition period can continue to be available on the market without a legal time restriction.ConclusionThe medical device industry and its stakeholders can breathe a sigh of relief. While it took some time for the European Commission and EU Member States to recognize that an extension of the transitional regime was imminent in order to avoid a European healthcare crisis and it was necessary to take action, the adoption of the proposal and its entry into force have been accomplished in an unexpectedly swift process.However, while the time extensions provided by the Regulation may seem comfortable, manufacturers should be aware that important deadlines are fast approaching. Under each scenario, an MDR-compliant quality management system must be implemented and a formal application filed with a notified body by May 26, 2024. Of course, it can be expected that there will be a massive run on notified bodies at the end of this period. Thus, manufacturers would be well advised to prepare and submit their applications as soon as possible. Watch this space for further updates on this and other EU regulatory issues.

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Counsel

Robert advises companies in the healthcare, pharmaceutical, medical device, and technology industries on all aspects of intellectual property law, primarily in connection with commercial life sciences, licensing, and technology transactions. His clients range from multinational companies to startups.

Robert Grohmann

Robert Grohmann is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising domestic and foreign companies and startups in all areas of technology and IP law, including patent and software licensing, employee inventions law, as well as know-how protection. Moreover, Mr. Grohmann’s expertise encompasses the judicial and extra-judicial representation in matters of trademark law, design law, and competition law.

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Eu Mdr and Ivdr Implementation: New Transitional Regime Enters Into Force

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On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the “Regulation”) was published in the Official Journal of the European Union. The Regulation provides for highly anticipated extensions of the transition periods under the EU Medical Device Regulation (MDR) and certain related provisions under the EU In Vitro Diagnostic Medical Device Regulation (IVDR).

Eu Mdr and Ivdr Implementation: New Transitional Regime Enters Into Force

<a href="https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf" target="_blank">The Biden administration announced</a> on January 30, 2023, that it plans to terminate the COVID-19 public health emergency declaration (the “PHE declaration”) on May 11, 2023.COVID-19 EUA medical products and policiesAs FDA has clarified in its <a href="https://www.fda.gov/media/155039/download" target="_blank">draft transition guidance for medical devices</a>, the Emergency Use Authorizations (EUAs) of COVID-19 medical products may remain in effect regardless of the PHE declaration status. FDA’s EUA authority is based on the emergency use declaration under section 564 of the Federal Food, Drug, and Cosmetic Act (the “EUA declaration”), whereas the PHE declaration is under section 319 of the Public Health Service Act. Currently, there are active COVID-19 EUA declarations including those for <a href="https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency" target="_blank">in vitro diagnostics (IVDs)</a>, <a href="https://www.federalregister.gov/documents/2020/03/27/2020-06541/emergency-use-authorization-declaration" target="_blank">medical devices</a>, and <a href="https://www.federalregister.gov/documents/2020/04/01/2020-06905/emergency-use-authorization-declaration" target="_blank">drugs and biological products</a>. These EUA declarations could remain active for many years without the PHE declaration, to support existing COVID-19 EUAs and subject to FDA’s policy, new EUAs.Whether FDA’s policies for COVID-19 medical products will remain in effect, however, may depend on whether these policies are tied to the PHE declaration. For example, FDA has recently decoupled two guidance documents on COVID-19 tests from the PHE declaration, as we discussed <a href="https://lifesciences.mofo.com/topics/fda-updates-covid-19-testing-guidances" target="_blank">here</a>. On the other hand, many COVID-19 policies, such as those for vaccines and treatments, are still tied to the PHE declaration. We will need to wait and see whether FDA will decouple all or part of these policies from the PHE declaration before its termination, and that may have implications for how CBER and CDER exercise their emergency use authority for COVID-19 therapeutics and vaccines, including products to treat long COVID.COVID-19 test, treatment, and vaccine reimbursement and coverageTermination of the PHE declaration will change reimbursement and coverage requirements for COVID-19 tests, treatments, and vaccines. For example, traditional Medicare will no longer cover COVID-19 over-the-counter (OTC) tests once the PHE declaration ends, and will continue to cover diagnostic laboratory tests for COVID-19 only if ordered by a physician or other applicable practitioner. Medicaid is expected to cover all COVID-19 tests at no cost to patients until September 2024 if the PHE declaration ends in May 2023, as planned.  After September 2024, however, Medicaid will cover diagnostic laboratory tests for COVID-19 only if ordered by a physician or other applicable practitioner, and its coverage of COVID-19 OTC tests will be determined by each state. In the private sector, coverage of COVID-19 tests will again be up to the discretion of the private payors once the PHE declaration ends.Regarding COVID-19 treatments, Medicare may no longer cover certain COVID-19 treatments such as <a href="https://www.cms.gov/files/document/covid-medicare-monoclonal-antibody-infusion-program-instruction.pdf" target="_blank">monoclonal antibody infusion therapies with EUAs</a> once the PHE declaration ends. However, Medicare will continue to cover prescription-only oral antiviral drugs under EUAs until December 31, 2024, regardless of the PHE declaration status. Medicaid will cover COVID-19 treatments at no cost to patients until September 2024 if the PHE declaration ends in May 2023, as planned. After September 2024, however, states may implement cost-sharing.Regarding vaccines, Medicaid may continue to cover COVID-19 vaccines after the PHE declaration ends, as the <a href="https://www.congress.gov/117/plaws/publ169/PLAW-117publ169.pdf" target="_blank">Inflation Reduction Act</a> requires coverage of “approved vaccines” recommended by the Advisory Committee on Immunization Practices (ACIP). However, whether the <a href="https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines" target="_blank">COVID-19 vaccines under EUAs</a> would qualify as “approved vaccines” for Medicaid coverage depends on the ACIP. Private payors will no longer be required to cover COVID-19 vaccines after the PHE declaration ends.TelehealthFor telehealth services, the U.S. Department of Health & Human Services (HHS) Secretary, through the U.S. Centers for Medicare and Medicaid Services (CMS) has <a href="https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet" target="_blank">temporarily expanded Medicare coverage of telehealth services</a>, based on the authorities granted to the Secretary by the <a href="https://www.govinfo.gov/content/pkg/COMPS-15754/pdf/COMPS-15754.pdf" target="_blank">CARES Act</a> and the <a href="https://www.govinfo.gov/content/pkg/COMPS-15675/pdf/COMPS-15675.pdf" target="_blank">Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020</a>. These temporary measures will no longer be effective once the PHE declaration ends. However, the <a href="https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf" target="_blank">Consolidated Appropriations Act, 2023</a> extends certain flexibilities until December 31, 2024, including: (i) removing geographic requirements and expanding originating sites; (ii) expanding eligible practitioners; (iii) extending telehealth services for federally qualified health centers and rural health clinics; (iv) delaying the in-person requirements under Medicare for mental health services furnished through telehealth and telecommunications technology; (v) allowing for the furnishing of audio-only telehealth services; and (vi) using telehealth to conduct face-to-face encounters prior to recertification of eligibility for hospice care during emergency period.The additional flexibility in prescribing and dispensing schedule II–V controlled substances via telehealth, based on subsection 102(54)(D) of the <a href="https://www.govinfo.gov/content/pkg/COMPS-10355/pdf/COMPS-10355.pdf" target="_blank">Controlled Substances Act</a>, will end once the PHE declaration ends.Please reach out to MoFo’s FDA + Healthcare Regulatory and Compliance practice for a more detailed analysis and discussion of the implications of these developments.

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Ending the COVID-19 Public Health Emergency – What Happens Next

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The Biden administration announced on January 30, 2023, that it plans to terminate the COVID-19 public health emergency declaration (the “PHE declaration”) on May 11, 2023.

Ending the COVID-19 Public Health Emergency – What Happens Next