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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LinkedIN

FDLI hosted a virtual conference November 9-10, 2021, titled Digital Health Technology and Regulation During COVID-19 and Beyond. One of the keynote events was the panel on “FDA’s Digital Health Center of Excellence: Working with the FDA on Digital Health.” The panel featured Bakul Patel - Director of CDRH Digital Health Center of Excellence, Zachary Henderson - Head of Legal at Levels Health, and Diane Johnson - Senior Director of Strategic Regulatory, MD&D at Johnson & Johnson.  Shelby Buettner, Principal Legal Counsel at Medtronic, moderated the panel discussion.Below are three key takeaways from the panel discussion:<ol><li>Intentionality of Functionality. This is a key concept in the development of digital health products. Panelists discussed the importance of intentionality in creating and developing products in the digital health space, and the need to understand how the inclusion of or change to some functionalities may impact the level of regulatory oversight. Bakul Patel, Director of the Digital Health Center of Excellence, emphasized the importance of breaking down and parsing out the different functionalities of a digital health software product, especially in communications with FDA, to effectively evaluate if and how the product may fall within FDA’s regulatory purview. </li><li>Early Communications. Panelists discussed how much information should be provided to FDA in early communications and what level of detail is actually helpful in early stages. Bakul Patel noted that manufacturers should strike a balance, providing more than just an idea but not too much information. Ideally, FDA would like companies to read the applicable FDA guidance and come to FDA with specific questions about how the guidance applies to them.</li><li>Development of Guidances. FDA has announced its intention to publish guidance on marketing submission recommendations for change control plans for AI/ML device software function in 2022. In addition, FDA’s final report on the <a href="https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-program">Digital Health Software Precertification Pilot Program</a> is expected to be published soon outlining key learnings from the pilot. Examples in FDA guidance have great utility and FDA is continuing to figure out ways to craft helpful examples that provide enough detail without losing applicability across various stakeholders. FDA recognizes the usefulness of examples in guidance documents and notes that interactions with and feedback from industry stakeholders will be essential in continuing to provide detailed and meaningful guidance and examples for industry.</li></ol>Morrison & Foerster’s Stacy Cline Amin served on the planning committee for this conference. For questions on any of the topics discussed, please contact the authors or a member of MoFo’s FDA Regulatory + Compliance practice.

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Three Key Takeaways from FDLI’s Panel Discussion on FDA’s Digital Health Center of Excellence and Working with the FDA in the Digital Health Space

Recent Digital Health-Related FDA Announcements

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FDLI hosted a virtual conference November 9-10, 2021, titled Digital Health Technology and Regulation During COVID-19 and Beyond. One of the keynote events was 

Three Key Takeaways from FDLI’s Panel Discussion on FDA’s Digital Health Center of Excellence and Working with the FDA in the Digital Health Space

United States

Digital Health

The Food and Drug Law Institute (FDLI) hosted the virtual conference Digital Health Technology and Regulation During COVID-19 and Beyond, November 9-10, 2021. Morrison & Foerster’s Stacy Cline Amin and Bethany Hills led panel discussions during the two-day conference.  Stacy Cline Amin, who served on the conference planning committee, moderated a panel discussion on congressional perspectives and considerations in the digital health space. Bethany Hills participated on a panel discussion on evolutions in telehealth regulation and reimbursement, with a focus on recent developments in 2021. Below are key topics and takeaways discussed during the panels.<h4>Congressional Perspectives in Digital Health</h4>This panel featured senior staff from both of the FDA’s committees of jurisdiction, the Senate Health Committee and the Senate Finance Committee, the House Energy & Commerce Committee, as well as senior staff who led the negotiations for the 21st Century Cures Act.<ol><li>At the time the 21st Century Cures Act was drafted and negotiated, Congress had in mind smart watches and similar digital health technology that is far less complicated than the realities of the technology today.  The advancements and increased technological complexity have brought a slew of intricate questions about when and how FDA regulation should come into play and whether Congress should provide more clarity for the industry.  For example, how should clinical decision support be defined, and at what point should it be subjected to FDA regulatory review or approval?    </li><li>In the artificial intelligence and machine learning (AI/ML) space, panelists discussed the challenges of regulating technology that is continuously changing and the potential incompatibility of AI/ML technologies with existing regulatory frameworks, such as change protocols.  Panelists emphasized the importance of having patients and providers at the table in these ongoing discussions and ensuring that Congressional stakeholders and constituents can understand the technology and mechanics in order to make meaningful decisions. </li><li>Congress is considering these issues as part of the Medical Device User Fee Amendments. Panelists encouraged industry stakeholders and constituents to provide comments and insights to Congressional representatives and staff as these discussion continue.</li></ol><h4>Telehealth 2021:  Regulatory and Reimbursement Developments</h4><ol><li>As we begin to approach the end of the pandemic, the waivers and exemptions extended during the public health emergency have begun to be withdrawn.  Without action from Congress, most Medicare beneficiaries of telehealth will lose access to the majority of telehealth services available during the pandemic.  While many stakeholders are advocating for permanent changes to law regarding telehealth access, a simple extension of the current wavier period is more likely as a near-term action.  Of note, the Centers for Medicare and Medicaid Services (CMS) has already expanded its definition of telehealth services to include audio-only services for mental health services.  </li><li>CMS has created carve-outs for services that may not be defined exactly as telehealth services, but that are supportive of and integrated with telehealth, such as remote physiologic and therapeutic monitoring.  Changes to the RPM and RTM codes and guidelines indicate a certain degree of desired flexibility, but also come with additional questions and areas of ambiguity.  </li><li>Digital health companies are taking advantage of the health insurance adoption of telehealth, maximizing the benefit of telehealth and its potential to lower costs while enhancing patient care.  However, there are a number of challenging issues going forward, particularly with digital-first health insurance offerings and direct-to-consumer (DTC) telehealth products that incorporate insurance‑like features.  In addition, many states issued waivers permitting clinicians to practice across state borders without licensure during the pandemic.  As state-level licensure waivers are winding down, this poses challenges for digital health providers in constructing and maintaining viable provider networks for insurance and DTC markets.</li></ol>For questions on any of the topics discussed at this meeting, please contact the authors or a member of MoFo’s FDA Regulatory + Compliance practice.

Morrison & Foerster Partners Speak at FDLI’s Digital Health Technology and Regulation Conference

The Food and Drug Law Institute (FDLI) hosted the virtual conference Digital Health Technology and Regulation During COVID-19 and Beyond, November 9-10, 2021. 


Morrison & Foerster Partners Speak at FDLI’s Digital Health Technology and Regulation Conference

MedTech

This week the U.S. Food and Drug Administration (FDA), along with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), identified <a href="https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles?utm_medium=email&utm_source=govdelivery&utm_source=STAT+Newsletters&utm_campaign=6a098880a8-health_tech_COPY_01&utm_medium=email&utm_term=0_8cab1d7961-6a098880a8-153551262" target="_blank">10 guiding principles</a> to inform the development of Good Machine Learning Practice (GMLP) and promote safe and effective medical devices that use artificial intelligence and machine learning (AI/ML).  The guiding principles “identify areas where the International Medical Device Regulators Forum (IMDRF), international standards organizations, and other collaborative bodies could work to advance GMLP,” including creation of educational tools and resources, international harmonization, and consensus standards.<img alt="Good Machine Learning" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt4bac1f9a18159f5f/6273178d4d9f89297129022f/211101-good-machine.jpg?format=auto&quality=60" type="asset" sys-style-type="download">The guiding principles reflect some of the focus topics articulated in FDA’s <a href="https://lifesciences.mofo.com/topics/five-key-takeaways-from-FDAs-transparency-of-AIML-enabled-medical-devices-virtual-workshop.html" target="_blank">Transparency of AI/ML-Enabled Medical Devices Virtual Workshop</a>.  For example, the guiding principles recommend that “users are provided clear, essential information,” emphasizing the importance of providing clear, contextually relevant information about the device to the intended audience.  The principles also include requirements that “testing demonstrates device performance during clinically relevant conditions,” and “deployed models are monitored for performance and re-training risks are managed.”FDA welcomes feedback through the public docket at Regulations.gov (<a href="https://www.regulations.gov/docket/FDA-2019-N-1185" target="_blank">FDA-2019-N-1185</a>) and may be contacted directly at <a href="mailto:Digitalhealth@fda.hhs.gov" target="_blank">Digitalhealth@fda.hhs.gov</a>.  Health Canada and the UK’s MHRA may be contacted directly at <a href="mailto:mddpolicy-politiquesdim@hc-sc.gc.ca" target="_blank">mddpolicy-politiquesdim@hc-sc.gc.ca</a> and <a href="mailto:software@mhra.gov.uk" target="_blank">software@mhra.gov.uk</a> respectively.For questions on any of the topics discussed at this meeting, please contact the authors or a member of MoFo’s <a href="https://www.mofo.com/capabilities/fda-life-sciences-compliance.html" target="_blank">FDA Regulatory + Compliance</a> practice.

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FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development

FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation

mofolifesciences-medical-devices

This week the U.S. Food and Drug Administration (FDA), along with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MH

FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development

Regulatory

On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices.  The workshop focused on the role of transparency in enhancing the safe and effective use of AI/ML technology in the medical device space, with an emphasis on information-sharing methods for patients, caregivers, and providers.Below are five key takeaways from the workshop:<ol><li>Cultivating user awareness for both patients and healthcare providers will be a key area of focus for AI/ML-enabled device manufacturers and regulators going forward.  In presentations and panel discussions, many panelists expressed concern as to whether healthcare providers would understand the limitations of AI/ML devices and be able to properly interpret and use the data in administering care.</li><li>Transparency and effective communication of AI/ML medical device labeling will be important to consider for all user types.  Panelists discussed the idea of a nutrition facts label approach to AI/ML device labeling, using the analogy of food labeling to describe the balance of information and detail needed to enable users to make informed decisions.</li><li>Bias and systemic discrimination remain persistent issues in the AI/ML space.  FDA and various industry stakeholders expressed commitment to ensuring that the data used to train AI/ML models are diverse and accurately reflect the patient population in which the technology will be used.  Use of synthetic or artificial datasets to close the data gap and ensure devices are trained using ethnically diverse datasets has been a particularly relevant discussion.</li><li>Inequality, from both a patient and a manufacturer perspective, was a key topic of conversation during the workshop.  Panelists discussed the potential for inequitable access to AI/ML devices across different patient populations, as well as the potential for unequal access to data amongst manufacturers in the industry.</li><li>Transparency surrounding tracking and reporting of device error or malfunctions will be an important topic of discussion as AI/ML-enabled devices are made available.  Panelists discussed the potential for two-way communication between manufacturers and users, and FDA’s role in promoting such transparency.</li></ol>The recording of the webcast, transcript, and presentation slides will be posted on the Workshop webpage within the next few weeks.  FDA will continue to receive and review comments and questions regarding transparency of AI/ML-enabled medical devices online on the public docket.  Comments may be submitted on <a href="https://www.regulations.gov/" target="_blank">regulations.gov</a> (Docket No. FDA-2019-N-1185) until November 15, 2021.For questions on any of the topics discussed at this meeting, please contact the authors or a member of MoFo’s <a target="_blank" href="https://www.mofo.com/capabilities/fda-life-sciences-compliance.html">FDA Regulatory + Compliance</a> practice.

Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop

On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning 

Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop

Healthcare

On September 30, 2021, the U.S. Food and Drug Administration (FDA) <a target="_blank" href="https://www.federalregister.gov/documents/2021/09/30/2021-21324/interpreting-sameness-of-gene-therapy-products-under-the-orphan-drug-regulations-guidance-for">announced</a> final guidance titled “<a target="_blank" href="https://www.fda.gov/media/134731/download">Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations</a>.”  The guidance finalizes the January 2020 draft guidance and provides FDA’s current perspective on certain criteria that help determine sameness of human gene therapy products for orphan drug designation and exclusivity purposes.  In the Federal Register notice announcing the final guidance, FDA noted that it received comments on the draft guidance that “generally supported the approach described in the guidance.”  FDA considered these comments and requests for additional clarification when finalizing the guidance, “adding clarification and examples, as feasible.”<h4>Background</h4>The Orphan Drug Act (ODA) seeks to incentivize the development of drugs for rare diseases, defined in the ODA as those affecting fewer than 200,000 people in the United States.  The incentives include a 25% tax credit on applicable research and development expenditures, waived user fees when submitting applications to FDA, and the potential for a seven-year period of orphan drug exclusivity for the approved indication.  Manufacturers must request and be granted designation before they are eligible for any incentives. When FDA grants marketing approval for a designated orphan drug for a use or indication within the designation disease or condition, FDA will determine if the drug is eligible for orphan drug exclusivity.  Orphan drug exclusivity is product and indication specific, meaning FDA cannot approve a drug containing the same active moiety for the same intended use or indication during the period of marketing exclusivity. FDA uses different criteria in determining sameness for macromolecule and small molecule drugs [1]. The FDA defines “same drug” for macromolecule drugs as “a drug that contains the same principal molecular structural features (but not necessarily all of the same structural features) and is intended for the same use as a previously approved drug, except that, if the subsequent drug can be shown to be clinically superior, it will not be considered to be the same drug." [2]If a sponsor requests orphan drug designation for a drug that is the same as a drug already approved for the same use or indication, the sponsor must provide a plausible hypothesis that its drug is clinically superior to the already approved drug.  Designation as clinically superior is based on greater efficacy, safety, or a major contribution to patient care.  In order to receive the seven-year market exclusivity, a sponsor must demonstrate that its product is actually clinically superior.<h4>Interpreting Sameness of Gene Therapy Products</h4>Human gene therapy products may qualify for orphan drug designation if they are intended for the treatment of a rare disease or condition and the sponsor sufficiently establishes a basis for expecting the drug to be effective in treating the rare disease.  The existing regulations do not describe how the “same drug” definition applies specifically to gene therapy products for orphan drug designation and exclusivity.  Mirroring the January 2020 draft guidance, FDA’s final guidance provides some insight into the current interpretation of how the “sameness” criteria applies to gene therapies.Assuming that two gene therapy products are intended for the same use or indication, FDA will consider the “principal molecular structural features” of the gene therapy products when determining “sameness.”  In the final guidance, FDA states its intention to generally “consider certain key features such as transgenes and vectors used in gene therapy products to be ‘principal molecular structural features’ under this regulation.”  However, FDA does not intend to classify two gene therapy products as different based solely on minor differences in the transgenes and/or vectors, and will determine whether differences are minor differences on a case-by-case basis.For two gene therapy products intended for the same use or indication, if the products express different transgenes, FDA generally intends to consider them to be different drugs because they will not contain the same principal molecular structural features.  This would be the case regardless of whether the two gene therapy products at issue have or use the same vector.  FDA also intends to consider vectors from a different viral group to be different for purposes of determining “sameness.”  Additionally, FDA clarified in the final guidance that it will consider two gene therapy products from the same viral group to be different “when the differences between the vectors impact factors such as tropism, immune response avoidance, or potential insertional mutagenesis.”  FDA intends to determine whether variants of a vector from the same viral group are the same or different on a case-by-case basis.In a case where two gene therapy products express the same transgene and have/use the same vector, FDA may also consider additional features of the final product when determining “sameness,” such as regulatory elements (e.g., promoters or enhancers).  In these instances, FDA generally intends to determine “sameness” of gene therapy products on a case-by-case basis.[1] 21 CFR 316.3(b)(14).[2] 21 CFR 316.3(b)(14)(ii).

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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 Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products

The EU General Court’s Ruling on Pay for Delay

mofolifesciences-pharma

On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orp

FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products

Rare Disease

Pharma

Cell + Gene Therapy

Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated <a target="_blank" href="https://aspe.hhs.gov/sites/default/files/2021-09/Drug_Pricing_Plan_9-9-2021.pdf">report</a> to the White House Competition Counsel regarding a “Comprehensive Plan for Addressing High Drug Prices.” The HHS Report—issued in response to President Biden’s <a target="_blank" href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/">Executive Order on Promoting Competition in the American Economy</a>—contains a range of approaches for effecting reforms aimed at reducing the price of prescription drugs. Among these proposed reforms are administrative actions that will be undertaken by the Food and Drug Administration to “address potential barriers to biosimilar and generic drug development and market entry to spur competition so that consumers can access the medicines they need at affordable prices.” HHS Report at 19.For both the biosimilar and generic drug marketing pathways, HHS emphasized the importance of labeling carve-outs—so-called “skinny” labels—under 21 U.S.C § 355(j)(2)(A)(viii) as a way to “decrease[] costs to patients and to the federal government, including reducing spending on Medicare and Medicaid.” HHS Report at 21. HHS’s emphasis appears driven in part by a recent case before the Federal Circuit, GlaxoSmithKline v. Teva Pharmaceuticals USA, Inc., addressing patent-infringement liability for generic drug manufacturers that employ skinny labeling practices. 976 F.3d 1347 (Fed. Cir. 2020), aff’d in part and vacated in part, 7 F.4th 1320 (Fed. Cir. 2021); HHS Report at 21 (“Recent litigation has raised some questions about the practice of carving out patent-protected indications for generic drugs, which may discourage the use of carve-outs and thus delay the approval of some generic drugs.”).The patent at issue in GlaxoSmithKline covered the use of Coreg® (carvedilol) to treat congestive heart failure. Teva’s label for its generic carvedilol product omitted this patented indication when FDA first approved it but retained indications for two other approved uses: treatment of post-MI LVD (left ventricular dysfunction following post-myocardial infarction) and hypertension. During this time, however, Teva also marketed carvedilol as therapeutically equivalent to Coreg®, and there was evidence that post-MI LVD patients were also being treated with carvedilol for congestive heart failure. Beginning in 2011, Teva maintained the carve-out but added language elsewhere in the carvedilol label stating that it could be used to treat congestive heart failure. The jury found Teva liable for induced infringement, but the district court granted Teva judgment as a matter of law reversing the verdict. GSK appealed, and, last year, the Federal Circuit reversed the district court’s judgment, holding that the jury’s finding of induced infringement was supported by substantial evidence. GlaxoSmithKline, 976 F.3d 1347 (Fed. Cir. 2020). Teva subsequently requested rehearing, but the same three-judge panel <a target="_blank" href="http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/18-1976.OPINION.8-5-2021_1814836.pdf">affirmed </a>its prior judgment on August 5, 2021, again holding that substantial evidence supported the jury’s verdict that Teva was liable for inducing infringement.[1]The panel reiterated that its decision was limited to the particular factual circumstances presented. The panel emphasized, for example, that “GSK presented evidence that doctors read and consider labels, that Teva’s marketing materials guided doctors to the label and to its website promoting the patented use, that Teva issued press releases encouraging doctors to prescribe carvedilol for the patented use, that Teva’s own employees expected doctors to prescribe carvedilol during the partial label period for the patented uses, and expert testimony that Teva’s actions encouraged doctors to do so.” 7 F.4th at 1338. But the decision raised concerns among generic manufacturers that skinny labeling would not sufficiently shield them from liability and appears to have piqued HHS’s interest. In fact, Teva filed a <a target="_blank" href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltfbd4dcd9d59ab6e0/627317894d9f89297129022b/1429000-1429343-petition.pdf">petition</a> for en banc rehearing on October 7, 2021, in which it urged the full court to reject the panel’s decision because it would “throw inducement doctrine into disarray” and have a “seismic” effect on skinny-label cases.Given how recently GlaxoSmithKline was decided and the uncertainty about how the court will rule en banc, the scope of its impact on skinny labeling practices remains to be seen. The handful of opinions citing it so far have not expanded its application. See Roche Diagnostics Corp. v. Meso Scale Diagnostics, LLC, 503 F. Supp. 3d 156, 2020 U.S. Dist. LEXIS 223968 (D. Del. Nov. 30, 2020) (jury could reasonably infer lack of intent to induce infringement from “removal of field restrictions from [generic] labelling”); Niazi Licensing Corp. v. St. Jude Med. S.C., Inc., 2021 U.S. Dist. LEXIS 54618 (D. Minn. Mar. 23, 2021) (distinguishing GlaxoSmithKline in finding insufficient evidence of intent to induce infringement by generic manufacturer); United Food & Commer. Workers Local 1776 v. Takeda Pharm. Co., 2021 U.S. App. LEXIS 25572 (2d. Cir. Aug. 25, 2021) (citing GlaxoSmithKline solely for general proposition that a generic manufacturer may carve out patented uses). Nevertheless, and although the Court observed that “the FDA is not the arbiter of patent infringement issues,” the HHS Report concludes that HHS is “committed to taking steps as appropriate to ensure these critical [skinny label] practices remain available for generic drugs and biosimilars.”Check back to the <a target="_blank" href="https://lifesciences.mofo.com/">MoFo Life Sciences Blog</a> for updates on any specific actions HHS and/or FDA take to address skinny labeling. [1] Teva requested en banc rehearing, but the Federal Circuit interpreted its request as seeking panel rehearing. For a quick overview of this procedural quirk, see this <a target="_blank" href="https://federalcircuitry.mofo.com/topics/Know-Your-En-Banc-Petition-ProcessHow-An-En-Banc-Petition-In-GlaxoSmithKline-v-Teva-Led-To-A-New-Panel-Argument-Without-Apparent-En-Banc-Action.html">recent post </a>from MoFo’s Federal Circuitry blog.

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Fitz Collings is an IP litigator who puts science first to develop innovative litigation strategies for life sciences and technology companies.
Fitz counsels some of the largest pharmaceutical, biotec

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Fitz Collings

Skinny Labels Back in Focus after HHS Report on Addressing Drug Prices

Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report

Skinny Labels Back in Focus after HHS Report on Addressing Drug Prices

Litigation

Intellectual Property

Last week, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule (the “Proposed Rule”), which CMS published on January 14, 2021 in the waning days of the Trump administration (the “January Final Rule”). If it were to go into effect, the January Final Rule would be effective on December 15, 2021. In the Proposed Rule, CMS stated that it is seeking comments until October 15, 2021 on this proposed repeal of the January Final Rule and on CMS’s intent to conduct future rulemaking exploring an expedited coverage pathway that provides access to innovative beneficial technologies and defining “reasonable and necessary.”<h4>Procedural History</h4>The Proposed Rule represents a shift in CMS’s thinking between the previous and current administration. Originally, the January Final Rule established an expedited four-year Medicare coverage pathway for medical devices that the Food and Drug Administration (FDA) designated as breakthrough devices. Coverage would begin on the date of market authorization or at a date within two years thereafter, as chosen by the device manufacturer. The goal of the rulemaking was to provide Medicare beneficiaries with faster access to innovative medical devices. The January Final Rule, which finalized a proposed rule from September 1, 2020 that contained a sixty (60) day comment period, also promulgated regulations and standards to be used in identifying what items were “reasonable and necessary” for the purposes of items furnished under Medicare Parts A and B.In January 2021, at the beginning of the Biden administration, CMS issued an Interim Final Rule, delaying the effective date of the January Final Rule by sixty (60) days, from March 2021 to May 2021. However, in response to public comments to the Interim Final Rule, CMS determined that further delay of the Final Rule was necessary and issued another final rule in May 2021, which delayed the effective date of the January Final Rule until December 15, 2021. Fast forward to the Proposed Rule, where CMS stated that, after further consideration of public comments, it has changed its position on the issue and seeks to repeal the January Final Rule.<h4>CMS’s Rationale</h4>In the Proposed Rule, CMS articulated its concerns with the January Final Rule, stating that it believes the January Final Rule is not in the best interest of Medicare beneficiaries. CMS has concerns that the January Final Rule may provide multi-year, broad, national coverage for medical devices based on breakthrough designation alone, when the breakthrough designation alone does not provide adequate evidence that such device is the reasonable and necessary treatment for a Medicare patient who has the disease or condition that the device is intended to treat or diagnose.Additionally, CMS made particular note of the fact that FDA does not require that Medicare beneficiaries be included in clinical studies that are required for market-authorization of a medical device. The Proposed Rule hints that CMS feels this fact is a potential blind spot, particularly because the Medicare population consists of older people with comorbidities, and due to the Medicare population’s general underrepresentation in underlying clinical trials. CMS believes these facts make it difficult to assess whether the breakthrough devices are reasonable and necessary, as it is unclear whether the item/service would improve a Medicare beneficiary’s health outcome.Based on the foregoing, while not abandoning the aims of the January Final Rule, CMS does not believe the January Final Rule, as currently drafted, is the best way to achieve the goals of the various stakeholders. We expect that, in exploring its options in future rulemakings, CMS will likely require manufacturers that participate in new coverage pathways, like MCIT, to produce evidence to demonstrate the benefit of the device within the Medicare population.<h4>Supporters of the Rule</h4>Supporters of the rule argued in January 2021 that FDA’s determination of a device’s safety and efficacy, allowing for the marketing of such device, should be sufficient to support Medicare’s coverage of such device. Further, in the event of a future assessment of medical device safety concerns, the January Final Rule provided for termination of MCIT coverage in instances where FDA issues a Warning Letter or if FDA revokes the market authorization for a device. In the January Final Rule, CMS articulated that it believed its policy provided a balance of ensuring rapid adoption of breakthrough devices, which, by their definition, provide for more effective treatment or diagnosis for life-threatening or debilitating conditions, while benefiting Medicare beneficiaries. Public comments to the January Final Rule echoed this sentiment, in that an MCIT coverage pathway would result in faster and more consistent access to newly authorized technologies for Medicare beneficiaries. With the potential repeal of the January Final Rule, these supporters cite patient access concerns, particularly when patients and providers have exhausted existing medical options.Supporters of the MCIT Final Rule should keep a close look on the Cures 2.0 discussion draft (“Cures 2.0”), which codifies the MCIT pathway and requires Medicare coverage for breakthrough medical devices designated by the FDA for a four-year period. Cures 2.0 is a bipartisan effort to allow CMS to catch up with the FDA. Significantly, Cures 2.0 would move away from the “reasonable and necessary” standard for coverage decisions, potentially eliminating conflicts with the FDA’s “safe and effective” standard for device approval/clearance. If passed, Cures 2.0 would bring systematic changes to the U.S. healthcare payer system and, more importantly, provide Medicare patients timely access to innovative therapies.<h4>CMS Seeking Comments</h4>As stated above, CMS is seeking comments on the Proposed Rule until October 15, 2021 regarding the following topics: (1) its proposal to repeal the January Final Rule; (2) the definition of “reasonable and necessary” as used in the Social Security Act; and (3) comments on exploring other policy options and statutory authorities for coverage of devices that would better suit the needs of Medicare beneficiaries.

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CMS Proposes to Repeal MCIT Final Rule

Is 2021 the Value-Based and Shared Savings Revolution?

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Last week, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Defin

CMS Proposes to Repeal MCIT Final Rule

It’s summer blockbuster season and that means sequels abound.  Now it seems that the U.S. Congress wants in on the action.  Just five years after Congress passed the 21st Century Cures Act, a bipartisan group of representatives is looking to enact follow-up legislation—“Cures 2.0.”  Last month, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) released draft legislation that proposed sweeping policy changes, many of them inspired by the COVID-19 pandemic.  If passed into law, the 127-page legislation would affect medical research, health insurance, and FDA regulatory policies; it would even establish a new agency.This life sciences blog hopes to explain the discussion draft for Cures 2.0.  It begins with a quick recap of the first Cures Act, then explains the content of the proposed legislation.  Finally, we forecast what to expect going forward.<h4>21st Century Cures Act</h4>Congress enacted the 21st Century Cures Act to speed up the development of medical products and encourage more innovation, all with the end goal of curing hard-to-treat diseases.  The Act authorized $6.3 billion in funding, with approximately three-quarters of that money allotted to the National Institutes of Health (NIH).  The legislation funded new medical research programs at NIH, including the Cancer Moonshot, the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative, and the Precision Medicine Initiative.  The Cures Act also addressed health information technology interoperability, including significant provisions prohibiting information blocking.With respect to the Food & Drug Administration (FDA), the Cures Act modernized the agency’s hiring authorities.  It directed FDA to create intercenter institutes, such as the Oncology Center for Excellence.  It updated FDA’s regulation of combination products (which combine drugs, devices, and/or biological products).  It sought to streamline the drug approval process by facilitating the use of surrogate-markers, such as real-world evidence.  It created expedited product development programs, including <a target="_blank" href="https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation">Regenerative Medicine Advanced Therapy</a> (RMAT) and the <a target="_blank" href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program">Breakthrough Devices</a> program.  And it amended the Food, Drug, and Cosmetic Act to exclude certain software functions from the definition for medical devices.[1]President Obama signed the Cures Act into law on December 13, 2016, just weeks before leaving office.  The law enjoyed overwhelming support from industry and other stakeholders.  Notably, then-Vice President Biden was a major proponent of the legislation.<h4>Cures 2.0 Draft Legislation</h4>Cures 2.0 features five substantive titles.  This blog post details some of the most significant provisions.Title I covers public health, with an emphasis on learning from the COVID-19 pandemic.  It would establish a national survey of patients with long COVID, create a learning collaborative, and assess sources of coverage.  It would direct the Department of Health and Human Services (HHS) to develop and implement a national strategy to prevent and respond to pandemics.  The strategy would be “based on lessons learned, and best practices developed, as a result of the COVID-19 pandemic”; it would focus on testing, expanding domestic drug manufacturing, and developing vaccines, therapeutics, and other medical supplies.  The Act would appropriate $25 million per year in grants to educate the public about vaccines.  And it would adopt the PASTEUR Act, which would create an innovative subscription model to pay for the development of novel antibiotics to address antimicrobial resistance.Title II covers patients and caregivers and directs the Centers for Medicare & Medicaid Services (CMS) to consider ways to improve patient health literacy, among other goals.  Title II would also work to increase diversity in clinical trials through, for example, public awareness campaigns and more user-friendly registration.  It would also require reporting on patient experience data in a clinical trial and require FDA to consider that data.Title III covers provisions relating to FDA.  It would direct FDA to report to Congress on the agency’s coordination of the regulation of digital health products, which include wearables, artificial intelligence, cloud services, and software.  It would create grants for innovative clinical trial design.  Title III also focuses on accelerated approval programs for drugs.  It would direct FDA to issue guidances on the chemistry, manufacturing, and controls information required for expedited approval and the use of real world evidence to evaluate the safety and effectiveness of drugs after approval or licensure under a breakthrough, fast-track, or accelerated pathway.  It would allow for earlier designation as an RMAT or breakthrough therapy before an Investigational New Drug (IND) and would allow for more sources of data to support post-approval study requirements.  Title III also addresses improving collaboration between FDA and CMS regarding designation of a product as a breakthrough therapy, a fast- track product, or a product eligible for accelerated approval. Title IV covers CMS separately, with a particular emphasis on telehealth coverage.  It would extend telehealth flexibilities offered during the pandemic to permanently remove geographic and originating site restrictions and it would encourage the use of telehealth  for Medicaid and the Children’s Health Insurance Program (CHIP).  It would also address patient access to breakthrough devices by codifying the current Medicare Coverage of Innovative Technology pathway.  It would provide federal support for the use of genetic and genomic testing for pediatric patients with rare diseases and would create a pilot grant program within CMS to test approaches to delivering personalized medicine consultations.Last, but certainly not least, Title V of Cures 2.0 would establish a new agency called the Advanced Research Projects Agency for Health (ARPA-H) within NIH.  Modeled after the Defense Advanced Research Projects Agency (DARPA), ARPA-H would promote bold breakthroughs in medicine.  Examples of potential ARPA-H projects include mRNA vaccines for most cancers, wearable monitoring devices for blood pressure/blood sugar, brain imaging technology for tracking responses to Alzheimer’s therapies, vaccine patches or oral sprays for mass vaccination campaigns, and programs aimed at healthcare access and equity, according to an article that the White House published in <a target="_blank" href="https://science.sciencemag.org/content/373/6551/165">Science Magazine</a> to coincide with the draft legislation.  Cures 2.0 would provide $6.5 billion to ARPA-H in FY2022.<h4>What to Expect</h4>Cures 2.0 already enjoys bipartisan support and is a legislative priority for President Biden.  Rep. DeGette has <a href="https://news.bloomberglaw.com/pharma-and-life-sciences/bidens-6-5-billion-biomedical-agency-backed-in-bipartisan-bill" target="_blank">publicly proclaimed</a> that she hopes to pass the bill later this year.  For now, Congress and the White House are focused on <a href="https://news.bloomberglaw.com/pharma-and-life-sciences/bidens-speedy-medical-lab-will-ideally-be-up-in-fiscal-2022" target="_blank">gathering feedback</a> from industry, academia, and other groups.  This process is already underway, with many notable organizations praising the discussion draft and providing detailed comments.  We encourage life sciences companies that are interested in providing feedback to submit comments to Congress as soon as possible.Even enactment of Cures 2.0 would be far from the final word.  The discussion draft delegates significant authority to regulatory agencies and requires those agencies to issue regulations and guidance on several topics.  Such regulatory actions would provide further opportunities for input from life sciences companies.  All in all, the next several years will be an exciting time for drug, medical device, and life sciences innovations, thanks in large part to Cures 2.0.  This is one sequel that promises to be as exciting as the original.[1] The FDA promulgated a <a target="_blank" href="https://www.federalregister.gov/documents/2021/04/19/2021-07860/medical-devices-medical-device-classification-regulations-to-conform-to-medical-software-provisions">new rule on this topic</a> earlier this year.

Cures 2.0: Will It Be Better Than the Original?

It’s summer blockbuster season and that means sequels abound.  Now it seems that the U.S. Congress wants in on the action.  Just five years after Congress passe

Cures 2.0: Will It Be Better Than the Original?

Christine Lentz, a Morrison & Foerster summer associate in our San Diego office, contributed to the writing of this article.The outbreak of the COVID-19 pandemic in 2020 spurred rapid medical and technological innovation, leading to new medicines and devices designed in response to the virus. Under the traditional U.S. Food and Drug Administration (FDA) process, approval for these products could take months, if not years—time many Americans did not have. Fortunately, the FDA had a secret weapon in the fight against COVID-19: emergency use authorizations (EUAs). In April 2020, we <a target="_blank" href="https://lifesciences.mofo.com/topics/FDA-uses-EUAs-broadly-in-the-fight-against-Covid-19.html">reported</a> on the FDA’s use of EUAs in the early months of the pandemic. Now, over one year later, we revisit the topic of EUAs to highlight the role they have played in pandemic responsiveness and explain what to expect going forward.<h4>EUAs Related to COVID-19</h4>Congress first established the FDA’s power to issue EUAs through the Project Bioshield Act of 2004. Generally speaking, EUAs enable the FDA to authorize unapproved products (or unapproved uses of approved products) for temporary use as emergency “medical countermeasures” against threats to public health and safety. From 2004 until recently, the FDA seldom issued EUAs; across the Zika, Ebola, MERS Coronavirus, H1N1/Swine flu, and Anthrax crises, the FDA issued EUAs for only a few dozen products combined.The COVID-19 pandemic, however, led to the issuance of over 600 EUAs, including authorizations for three <a target="_blank" href="https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines">vaccines</a> and ten <a target="_blank" href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs">drug and biological therapeutic products</a>, as well as a wide range of personal protective equipment, in vitro diagnostics, ventilators, and more. Among these authorizations, the FDA responded to the testing and supply shortages prevalent at the start of the pandemic by issuing several umbrella EUAs for larger categories of devices—e.g., Surgical Masks and Independently Validated Serology Tests for SARS-CoV-2—which allowed those products on the market without individual review.Several treatments for mild-to-moderate COVID-19 were authorized for emergency use, such as Gilead’s <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment">remdesivir</a>, GlaxoSmithKline’s <a target="_blank" href="https://www.fda.gov/media/149532/download">Sotrovimab</a>, Eli Lilly’s <a target="_blank" href="https://www.fda.gov/media/145801/download" title="Bamlanivimab and Etesevimab EUA Letter of Authorization February 25 2021">Bamlanivimab and Etesevimab</a>, and Regeneron’s <a target="_blank" href="https://www.fda.gov/media/145610/download" title="Regeneron LOA 6.3.2021">REGEN-COV (Casirivimab and Imdevimab)</a>. In addition, Fresenius Kabi received an EUA for its <a target="_blank" href="https://www.fda.gov/media/137888/download" title="Fresenius Kabi Propoven Emergency Use Letter of Authorization">Propoven 2% Emulsion</a> IV, which maintains sedation in patients requiring mechanical ventilation in an intensive care setting. Baxter Healthcare received authorization for its <a target="_blank" href="https://www.fda.gov/media/141168/download" title="Regiocit EUA Letter of Authorization">REGIOCIT replacement solution</a> for adults treated with continuous renal replacement therapy in a critical care setting during the COVID-19 pandemic.<h4>When Do EUAs End?</h4>EUAs remain in effect until the circumstances justifying the authorization of emergency use during the pandemic end, the FDA revokes the EUA to protect public health or safety, or the FDA approves a marketing application for the product/use. To determine whether products temporarily authorized under EUAs remain necessary, the FDA periodically reviews the circumstances and appropriateness of existing authorizations, particularly the status of product approval. If the sponsor is not actively working toward approval, licensure, or clearance, the FDA may consider terminating the EUA. If an EUA remains in effect for more than one year, the FDA must provide the sponsor with a written explanation of obstacles to approval and specific actions to overcome them.[1]During the current pandemic, the FDA has revoked, for a variety of reasons, three of its umbrella EUAs and several individual EUAs. One typical explanation for revocation is that when the FDA approves a product, it renders any prior EUA redundant. For example, the FDA revoked the corresponding EUA upon <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19">approving Gilead’s Veklury (remdesivir)</a> for use in adults and certain pediatric patients.Other times, however, the FDA revokes EUAs after learning that products are not completely effective or safe for use. Recent EUA revocations include reported adverse effects (<a target="_blank" href="https://www.fda.gov/media/138945/download">Chloroquine phosphate and hydroxychloroquine sulfate</a>); poor clinical performance (Chembio’s <a target="_blank" href="https://www.fda.gov/media/139109/download">DPP COVID-19 IgM/IgG System</a>); decreased effectiveness (Autobio’s <a target="_blank" href="https://www.fda.gov/media/140908/download">Anti-SARS-CoV-2 Rapid Test</a>; NovaSterilis’s <a target="_blank" href="https://www.fda.gov/media/145896/download">Nova2200 for Decontaminating Compatible N95 Respirators</a>); increased viral variant resistance (Eli Lilly’s <a target="_blank" href="https://www.fda.gov/media/147629/download">Bamlanivimab</a>); and/or excessive risk-benefit ratio.<h4>Re-prioritization of EUA Review for COVID-Related Products</h4>As the pandemic has evolved, so have public health needs and FDA priorities, which in turn have resulted in the discontinuation and de-prioritization of EUA application review for certain COVID-19 products.For example, according to recent guidance (May 2021), the FDA may decline to review or process new EUA requests for COVID-19 vaccines, unless those developers have previously engaged with the Agency on the development of their manufacturing process and clinical trials program. If a developer has already received feedback from the FDA, its EUA request is more likely to contain comprehensive data and information that meet authorization issuance requirements, whereas quality and data in new applications may prove difficult to verify.In addition to de-prioritizing new COVID-19 vaccine EUA submissions, the FDA no longer reviews requests nor adds new respirator models to the umbrella emergency use authorizations for <a target="_blank" href="https://www.fda.gov/media/136664/download" title="FFRS Manufactured in China Letter">Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China</a> (as of Oct. 15, 2020) or <a target="_blank" href="https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#imported">Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators</a> (as of Mar. 24, 2021). Respirator manufacturers who are not listed under the existing EUAs may submit a separate EUA request; however, the FDA does not encourage such submissions, as there is decreased demand for those devices.Given the country’s continued recovery from the COVID-19 pandemic, we can likely expect additional classes of products to become deprioritized or ineligible for EUA. For example, as the proportion of vaccinated citizens increases and hospitalization rates decrease, many of the medical devices the country had scrambled to make available over a year ago will become less critical.<h4>Preparing for Post-Pandemic</h4>Companies with current EUAs or those considering applying for emergency use of their products should consult legal counsel to ensure continuity of product marketing and commercialization when the COVID-19 public health emergency is ended and/or EUAs are no longer effective.Unless FDA announces a transitional policy for EUAs, manufacturers should assume they will need to receive full approval or clearance from the FDA to continue marketing their products after the public health emergency ends. For example, <a target="_blank" href="https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/historical-information-about-device-emergency-use-authorizations">several</a> Zika- and Ebola-related tests with emergency use authorizations received market clearance before the declared end of their respective emergencies. In October 2020, the FDA approved <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-ebola-virus">Inmazeb</a>, the first treatment for Ebola Virus in the United States. To date, <a target="_blank" href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-biologics">Pfizer-BioNTech</a> and Moderna have submitted BLAs for their mRNA vaccines, along with requests for <a target="_blank" href="https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review">Priority Review</a> to accelerate the approval process, while simultaneously expanding their EUAs.The FDA <a target="_blank" href="https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/faqs-emergency-use-authorizations-euas-medical-devices-during-covid-19-pandemic">encourages sponsors</a> of EUA products to follow up EUA issuance with an appropriate approval, biologics license application (BLA), or device premarket submission—such as 510(k), De Novo Classification Request, or Premarket Approval—so that authorized products can remain on the market with minimal interruption once the EUA is no longer in effect. The FDA further expects sponsors to include a plan for safety follow-up in their EUA requests, which will inform benefit-risk determinations in support of EUA continuation.The FDA also expects manufacturers who receive an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval. Once enough data is available, EUA holders should consider submitting applications for FDA approval, as the process can take several months. Legal counsel can assist sponsors in navigating applications to accelerate the approval process, e.g., for Fast Track, Priority Review, or Material Threat Medical Countermeasure Priority Review Vouchers. Although the Secretary of Health and Human Services (HHS) must provide sufficient advance notice to allow for the disposition of an unapproved product, and of any other provided information/labeling related to an unapproved use before an EUA declaration terminates, this can unnecessarily disrupt the commercialization of your COVID-19 products.Stay up-to-date with the latest COVID-19 legal and regulatory developments at MoFo’s <a href="https://lifesciences.mofo.com/" target="_blank">Life Sciences</a> blog, or visit <a href="https://www.mofo.com/resources" target="_blank">Morrison & Foerster’s Resource Center</a> for additional industry insights and events. [1] 21 U.S.C. § 360bbb-3.

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EUAs and the FDA’s Fight Against COVID-19: An Evolving Landscape

Virginia Becomes the First State to Adopt COVID-19 Workplace Safety Mandates

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Christine Lentz, a Morrison & Foerster summer associate in our San Diego office, contributed to the writing of this article.
The outbreak of the COVID-19 pandem

EUAs and the FDA’s Fight Against COVID-19: An Evolving Landscape

COVID-19

ASTM International recently approved a new performance standard that will tell consumers just how much protection their cloth face masks offer. Some face coverings like N-95 respirators and surgical masks must meet certain filtration requirements enforced by government agencies like the U.S. Occupational Safety and Health Administration (OSHA) and the U.S. Food and Drug Administration (FDA). But, until recently, other masks like reusable gaiters and cloth face coverings had no performance standards whatsoever, making it impossible for consumers to judge how protective their masks were or to compare one mask to another.Last month, ASTM International approved the new voluntary standard <a href="https://www.astm.org/Standards/F3502.htm" target="_blank">ASTM F3502-21</a> (F3502) for Barrier Face Coverings. It applies to cloth face masks and gaiters intended for everyday use, not to masks used in a medical setting or for worker protection, which are already regulated. The goal is to provide a baseline performance standard, but masks that do not make the cut can still be sold.Like most product performance standards, F3502 contains design, construction, and labeling requirements. It offers two classification levels based on the mask’s filtration efficiency and breathability. For particulate filtration efficiency, masks can meet the minimum requirements by filtering 20% or more of particles during testing, or the higher level 2 requirements by filtering 50% or more. Two levels are also available based on the masks’ airflow resistance, with a more breathable mask achieving a higher result. Manufacturers must verify their results at a certified test laboratory, and can then claim that their mask “Meets ASTM F3502” requirements and describe the mask’s performance levels.F3502 presents an interesting opportunity for mask manufacturers, which can now sell a high-quality face covering without necessarily meeting the high standards for medical-grade or N-95 masks. Because this is not a federal standard, the masks are not subject to federal agency approval such as FDA’s Emergency Use Authorization process for various medical face masks. Likewise, barrier face coverings do not qualify as medical countermeasures, so manufacturers are not eligible for the Public Readiness and Emergency Preparedness Act’s liability protections.Some masks have already met the F3502 standard and are available for purchase. It remains to be seen how heavily consumers will support the new standard by purchasing certified masks. In a market with no easy way for buyers to know how much protection their masks offer, this new standard may help consumers make more informed choices and encourage manufacturers to make better masks.

New Face Mask Performance Standard Has Consumers Covered

ASTM International recently approved a new performance standard that will tell consumers just how much protection their cloth face masks offer. Some face coveri