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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Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents communicating its policy on the manufacture of certain alcohol-based hand sanitizers. Recognizing the significant supply disruptions for hand sanitizers, and that compounders and manufacturers are better equipped than ordinary consumers to formulate safe and effective hand sanitizer products, FDA is providing flexibility in manufacturing such products during the COVID-19 public health emergency.Read our Class Dismissed <a target="_blank" href="https://classdismissed.mofo.com/fda/fda-calls-all-hands-on-deck-to-keep-hand-sanitizer-stocked/">blog post</a>.

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Lethal Injection Matters – Major Pharmaceutical Company

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In re Air Crash Near Peixoto de Azevedo, Brazil

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Co-Chair, Litigation Department

Erin Bosman is chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin M. Bosman

Erin Bosman is the Global Co-Chair of Morrison Foerster’s Litigation Department. Erin is also the founder and co-head of the Artificial Intelligence Group and former chair of the Complex Litigation + Advisement Practice Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

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An orthopedic implant company

A children&rsquo;s monthly subscription service product

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A smart fitness equipment company

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Julie Park provides analytic and strategic counsel for issues in product life cycle, product liability and defective products, consumer class actions, and more.

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Julie Park | Product Liability Lawyer

Julie Park protects her clients’ products no matter what kind of product issue they face—whether it is planning for new product development, recalling an existing product, or defending clients against product liability or consumer class actions. Drawing on her deep technical and legal expertise, Julie counsels clients on consumer product safety regulation and pharmaceutical and medical device preemption while also managing complex and multijurisdictional litigation both in state and federal court.

Julie Y. Park

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FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked

OFCCP Issues National Interest Exemption for New Coronavirus Relief Contracts

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Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. O

FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked

COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public Readiness and Emergency Preparedness (PREP) Act encourages drug and medical device companies to increase production of existing products currently in short supply, and to develop new innovative COVID-19 therapies and treatments by limiting tort liability for the goods.Read our Class Dismissed <a target="_blank" href="https://classdismissed.mofo.com/product-liability/prep-act-declaration-emboldens-drug-and-device-industry-to-innovate-in-the-face-of-a-growing-crisis/">blog post.</a>

Prep Act Declaration Emboldens Drug and Device Industry to Innovate In the Face Of a Growing Crisis

COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vacci

Prep Act Declaration Emboldens Drug and Device Industry to Innovate In the Face Of a Growing Crisis

The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) recently issued their first round of joint warning letters to several companies claiming their products—teas, essential oils, tinctures, and colloidal silver—could prevent or treat COVID-19.Read our Class Dismissed <a target="_blank" href="https://classdismissed.mofo.com/consumer-products/fda-and-ftc-send-warning-letters-to-companies-marketing-products-to-treat-coronavirus-state-attorneys-general-follow-suit/">blog post.</a>

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FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus (COVID-19); State Attorneys General Follow Suit

Implications of California’s Coronavirus Stay at Home Order for Employers

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The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then

FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus (COVID-19); State Attorneys General Follow Suit

On March 16, 2020, FDA issued its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Guidance”). The purpose of the Guidance is to expedite the availability of novel coronavirus (SARS-CoV-2) diagnostic tests in view of the current public health emergency. The Guidance contains policies regarding (i) laboratories’ development and use of certain tests prior to or without an Emergency Use Authorization (EUA), (ii) commercial manufacturers’ development and distribution of certain tests prior to an EUA, and (iii) development, use, and distribution of serological tests without an EUA.First, regarding laboratory tests, the Guidance provides two policies: one eventually requires an EUA submission and the other does not. Under the first prong, FDA has indicated that it will not object to a laboratory’s use of SARS-CoV-2 diagnostic tests (i) that occurs after validation and notification to the agency, (ii) for a reasonable time (about 15 business days), (iii) while preparing an EUA request, (iv) provided that the laboratory is certified and meets certain regulatory requirements under Clinical Laboratory Improvement Amendments (CLIA). However, if FDA, upon review of the EUA request, identifies a significant problem that cannot be addressed in a timely manner, the laboratory may have to stop using the test and issue test reports indicating that prior tests may be unreliable.Under the second prong, each state may authorize laboratories within its territory to develop and use SARS-CoV-2 diagnostic tests without notifying FDA of test validation and without engaging in the EUA process.Second, FDA has indicated that it will not object to a commercial manufacturer’s distribution of SARS-CoV-2 diagnostic kits (i) after validation and notification to the agency, (ii) for a reasonable time (about 15 business days), (iii) while preparing an EUA request, (iv) provided that the manufacturer posts instructions for use and data regarding performance of the kit on its website. However, it should be noted that the manufacturer may have to suspend distribution and recall its products if, upon review of the EUA request, FDA identifies a significant problem that cannot be addressed in a timely manner.Third, acknowledging the relative simplicity of serological tests, FDA has indicated that it will not object to a laboratory’s use, and a commercial manufacturer’s distribution of serological tests or kits for SARS-CoV-2 that occur after validation and notification to the agency, provided that certain information listed in section IV(D) of the Guidance is included in the test report (e.g., that the test is not FDA-reviewed).Lastly, it may be worth noting some general points. First, the policies in the Guidance do not apply to at-home testing. Second, where validation is required, FDA recommends the minimum testing described in section V of the Guidance. Finally, FDA recommends including a general statement in the test report that FDA review is pending, whenever that is the case.In sum, the policies set out in the Guidance allow laboratories and commercial manufacturers, under certain conditions, to start using or distributing diagnostic tests or kits for the novel coronavirus prior to or even without an EUA. In addition to the EUA process which is already an expedited authorization process, the new policies will further accelerate distribution and use of the tests.

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FDA’s New Guidance on Use and Distribution of COVID-19 Diagnostic Tests by Laboratories and Commercial Manufacturers

After Striking Deal with the President, the House of Representatives Passes Federal Relief Bill, the Families First Coronavirus Response Act

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On March 16, 2020, FDA issued its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Guidance”). The purpose of t

FDA’s New Guidance on Use and Distribution of COVID-19 Diagnostic Tests by Laboratories and Commercial Manufacturers

As industry continues to grapple with and implement the <a href="https://www.govinfo.gov/content/pkg/PLAW-113publ54/pdf/PLAW-113publ54.pdf" target="_blank">Drug Supply Chain Security Act</a> (DSCSA) enacted by Congress in 2013, some of the largest pharmaceutical companies believe they may have a solution to track prescription drugs across the supply chain to prevent the distribution of counterfeit medicines – blockchain.The DSCSA outlines steps to build an electronic, interoperable system to identify and trace, to the packaging level, prescription drugs distributed in the United States as they move throughout the supply chain, and this system must be in place by 2023. The Act includes several different requirements with varying mandatory implementation dates that extend through 2023. Under the Act, FDA is required to establish pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.On February 8, 2019, FDA announced the creation of the <a href="https://www.federalregister.gov/documents/2019/02/08/2019-01561/pilot-project-program-under-the-drug-supply-chain-security-act-program-announcement" target="_blank">DSCSA Pilot Project Program</a> to explore issues related to “utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, identifying the system attributes that are necessary to implement the requirements established under the DSCSA, and any other issues identified by FDA” (84 Fed. Reg. § 2879). Participants in the program were selected by FDA to reflect the diversity of the supply chain. One of the participants in the program is led by blockchain startup MediLedger, and includes a network of 24 companies in the industry, including several major pharmaceutical companies along with other manufacturers, distributors, retailers, and delivery entities. The MediLedger network tested blockchain in the verification of drug returns and recently published its Final Pilot Report in February 2020 detailing the benefits of using blockchain to implement the DSCSA. The MediLedger network believes that blockchain provides a feasible solution to the DSCSA’s track-and-trace requirements and can be used to validate the authenticity of drug identifiers throughout the supply chain in a central point of data sharing while protecting proprietary data.It is still unclear what FDA’s opinion will be on the use of blockchain to implement the DSCSA, and FDA will not release its final program report until all of the projects included in the pilot program are completed. FDA notes that selection of a project into the DSCSA Pilot Project Program is not an endorsement of a particular technology, but other key markers may give us a clue as to FDA’s current thinking. For example, FDA has been supportive of the use of blockchain technology as part of its <a href="https://www.fda.gov/food/conversations-experts-food-topics/deputy-commissioner-champions-more-digital-transparent-food-safety-system" target="_blank">New Era of Smarter Food Safety</a> initiative due to blockchain’s ability to work within decentralized and distributed food systems for full end-to-end traceability. However, based on MediLedger’s report, we know that there are several issues that FDA would need to work through before implementing a blockchain system throughout the industry.  For starters, a new set of standards governing the use of blockchain would need to be developed, including standards for data management among multiple blockchains and non-blockchain networks, recall and alert notification, ensuring authorized trading partner identification, the correction of system records, exception handling, and standards for testing and performance. A governance system would also be necessary, and while the MediLedger network believes that governance should come from the industry itself, FDA may disagree. Additionally, for the system to work, nearly all industry members (manufacturers, wholesalers, dispensers, service providers, etc.) would need to participate in one or more interoperable systems, as the lack of full participation can lead to breaks in the chain of custody, and with higher numbers of interconnected systems, the risk of misaligned and incorrect data increases. Other concerns include the discomfort with blockchain technology, costs for small industry players, international reach, and system security, including permitting only authorized trading partners to access the network. MediLedger’s report also notes that implementation of blockchain is a complex solution and will require a stabilization period, urging a distinction between the implementation date and FDA’s enforcement date of the DSCSA.

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Blockchain and The Drug Supply Chain Security Act (DSCSA)

Blockchain and The Drug Supply Chain Security Act (DSCSA)

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As industry continues to grapple with and implement the Drug Supply Chain Security Act (DSCSA) enacted by Congress in 2013, some of the largest pharmaceutical c

As we move into 2020, we’re starting a regular blog series highlighting noteworthy FDA updates regarding regulatory compliance, fraud and abuse cases, and product development issues every month. Our February recap is below.1. <a href="https://www.justice.gov/opa/pr/two-owners-telemedicine-companies-charged-roles-56-million-conspiracy-defraud-medicare-and" target="_blank">Two Owners of Telemedicine Companies Charged for Roles in $56 Million Conspiracy to Defraud Medicare and Receive Illegal Kickbacks in Exchange for Orders of Orthotic Braces</a> (Feb. 5, 2020) The indictment alleges that the owners operated purported telemedicine companies ACC and Tele Medcare, which had locations in Bayonne, New Jersey, Boca Raton, Florida, and Richmond Hill, Georgia. The indictment further alleges that the owners agreed to solicit and receive illegal kickbacks and bribes from patient recruiters, pharmacies, brace suppliers and others in exchange for the arranging for doctors to order medically unnecessary braces for beneficiaries of Medicare from approximately March 2017 through April 2019. In order to obtain the orders that were transmitted in exchange for kickbacks and bribes, the two owners, through ACC and Tele Medcare, recruited and hired health care providers to order braces for Medicare beneficiaries, the indictment alleges. The owners allegedly paid illegal kickbacks and bribes to health care providers to order braces for Medicare beneficiaries that were medically unnecessary, ineligible for Medicare reimbursement and/or not provided as represented.The indictment further alleges the brace orders were transferred to co-conspirator brace suppliers to support in excess of $56 million in false and fraudulent claims to Medicare that were submitted by brace suppliers and that Medicare paid these brace suppliers in excess of $28 million for these claims. This case underscores the importance of reviewing the entire financial and referral structure of healthcare and telemedicine businesses to ensure that all fraud and abuse laws are complied with in the structure and operation of the business.2. <a href="https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-cardiac-ultrasound-software-uses-artificial-intelligence-guide-user" target="_blank">FDA Authorizes Marketing of First Cardiac Ultrasound Software That Uses Artificial Intelligence to Guide User</a> (Feb. 7, 2020) Cardiac diagnostic tests are necessary to identify heart conditions. Among them are electrocardiograms (more widely known as an EKG or ECG), Holter monitors and cardiac ultrasound examinations. The software authorized by FDA is the first software authorized to guide users through cardiac ultrasound image acquisition. The Caption Guidance software was developed using machine learning to train the software to differentiate between acceptable and unacceptable image quality. This knowledge formed the basis of an interactive AI user interface that provides prescriptive guidance to users on how to maneuver the ultrasound probe to acquire standard echocardiographic images and video clips of diagnostic quality. The AI interface provides real-time feedback on potential image quality, can auto-capture video clips, and automatically saves the best video clip acquired from a particular view. Importantly, the cardiologist still reviews the images for a final assessment of the images and videos for patient evaluation. In its review of this device application, the FDA evaluated data from two independent studies. The FDA reviewed the device through the <a href="https://www.fda.gov/medical-devices/premarket-submissions/de-novo-classification-request" target="_blank">De Novo</a> premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.In addition, this week, the FDA hosted a public workshop titled “Evolving Role of Artificial Intelligence (AI) in Radiological Imaging” that discussed emerging applications of AI in radiological imaging, including AI devices intended to automate the diagnostic radiology workflow, as well as guided image acquisition. Discussions focused on best practices for the validation of AI-automated radiological imaging software and image acquisition devices, which is critical to assess safety and effectiveness. MoFo had a team participating in the program by webinar and we will be posting follow up details to <a href="https://lifesciences.mofo.com/" target="_blank">the Life Science Blog</a> in the coming weeks.3. <a href="https://www.fda.gov/news-events/press-announcements/fdas-actions-response-2019-novel-coronavirus-home-and-abroad" target="_blank">FDA’s Actions in Response to 2019 Novel Coronavirus (COVID-19) at Home and Abroad</a> (Feb. 14, 2020)(NB: We will be hosting a free webinar on Friday, March 6th, at 12:30pm EST: What GCs Need to Know About Coronavirus, hosted by Global Risk + Crisis Management partner David Newman and FDA Regulatory partner Bethany Hills. Please <a href="https://veracast.com/webcasts/mofo/mcle_programs/07143728.cfm" target="_blank">click here</a> to read more and register)FDA is focused on critical issues of supply chain impact, product quality impact, quality surveillance through modified inspectional approaches, fraudulent claims about products in the US, and increased attention through import processes. FDA is taking actions based on the assumption that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. To address this issue, FDA is not waiting for drug and device manufacturers to report shortages—they are proactively reaching out to manufacturers to identify potential disruptions or shortages.FDA has confirmed that there are no vaccines, gene therapies, or blood derivatives licensed by the FDA that are manufactured in China. Raw materials used in manufacturing of these products that do come from China and other locations in Southeast Asia could theoretically increase the risk of biologic products manufactured elsewhere, and thus FDA is in contact with biologics manufacturers to gauge any supply concerns regarding raw materials.FDA conducts approximately 500 inspections per year in China with the majority of these inspections being for drugs, foods and medical devices. The FDA is not currently conducting inspections in China due to the State Department warning advising against travel to China. For the month of February, the FDA identified all scheduled inspections in China, and they were either postponed or the agency was able to utilize other information to inform decisions allowing the products to enter our U.S. market. FDA has announced that the majority of routine surveillance inspections in China scheduled for March are for medical products and at this time are expected to be conducted at a later date.The FDA Fraud Team monitors on-line products promoted with claims to prevent, treat, mitigate or cure 19-nCoV (or coronavirus, in general). FDA established a cross-agency task force dedicated to closely monitoring for fraudulent products and false product claims related to COVID-19 and has already reached out to major retailers to ask for their help in monitoring their online marketplaces for fraudulent products with coronavirus and other pathogen claims.At this time, the FDA continues to review products imported from China using its routine import process and has not determined that additional measures are needed to protect public health. If necessary, the agency can increased import screening and foreign manufacturers importing into the U.S. should be aware of this potential risk.More details in our three-part series the FDA’s efforts to address a number of important public health issues, including <a target="_blank" href="https://lifesciences.mofo.com/topics/FDA-working-to-address-2019-novel-Coronavirus-product-safety-part-I.html">product safety (Part I)</a>, monitoring <a target="_blank" href="https://lifesciences.mofo.com/topics/FDA-working-to-address-2019-novel-Coronavirus-supply-chain-part-II.html">supply chain disruptions (Part II)</a>, and supporting emergency efforts to<a target="_blank" href="https://lifesciences.mofo.com/topics/FDA-working-to-address-2019-novel-Coronavirus-diagnosis-treatment-part-III.html"> diagnose and treat the disease (Part III).</a>4. <a href="https://www.fda.gov/news-events/press-announcements/fda-announces-collaborative-review-scientific-evidence-support-associations-between-genetic" target="_blank">FDA Announces Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications</a> (Feb. 20, 2020)Pharmacogenetic testing is a type of genetic test that in some instances can predict how a person will respond to specific medications. Thus, this type of testing offers promise for informing the selection or dosing of some medications for certain individuals. When there is sufficient scientific evidence demonstrating a relationship between how a person’s genes may impact their metabolism of a drug or how they may respond to the drug, this information can be useful for health care providers. However, for many medications, there is not sufficient scientific evidence to support using pharmacogenetic test results to inform prescribing decisions.In a 2018 safety communication, FDA <a href="https://www.fda.gov/news-events/press-announcements/jeffrey-shuren-md-jd-director-fdas-center-devices-and-radiological-health-and-janet-woodcock-md" target="_blank">warned</a> the public about the FDA’s concerns with firms offering genetic tests making claims about how to use the genetic test results to manage medication treatment that are not supported by recommendations in the FDA-approved drug labeling or other scientific evidence. FDA considers this a public health concerns because clinicians order tests to help them and their patients make better informed decisions.Many pharmacogenetic tests are being offered as laboratory developed tests (LDTs). For many years, FDA has, in an exercise of enforcement discretion, generally not enforced applicable regulatory requirements for LDTs, such as premarket review. The FDA developed its existing approach to LDT enforcement decades ago, when the field of LDTs was much different, and often relied on simpler technologies in local settings. FDA noted in its press release: “FDA should not and cannot stand idly by when safety issues arise. Consistent with our mission to protect and promote public health, we believe it is important to take steps now to help ensure that claims being made for pharmacogenetic tests offered today are grounded in sound science to avoid inappropriate management of patients’ medications—and to do so through approaches that both protect patients and advance the development of analytically and clinically validated pharmacogenetic tests.”To address these concerns, FDA has introduced a unique collaboration between the FDA’s Center for Devices and Radiological Health and Center for Drug Evaluation and Research intended to provide the agency’s view of the state of the current science in pharmacogenetics. FDA’s new <a href="https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations" target="_blank">web-based resource</a> includes a table that describes some of the gene-drug interactions for which the Agency believes there is sufficient scientific evidence to support the described associations between certain genetic variants, or genetic variant-inferred phenotypes, and altered drug metabolism, and in certain cases, differential therapeutic effects, including differences in risks of adverse events. What FDA has not indicated is how this public resource will affect existing pharmacogenetic products in the marketplace or how FDA will consider new information to be added to or compared against this public database.

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February FDA Updates

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As we move into 2020, we’re starting a regular blog series highlighting noteworthy FDA updates regarding regulatory compliance, fraud and abuse cases, and produ

February FDA Updates

FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including product safety, monitoring supply chain disruptions, and supporting emergency efforts to diagnose and treat the disease. In addition, FDA is addressing safety concerns with its own workforce. In this three-part series, we explain FDA’s efforts in each of these areas and highlight the impact on different sectors of the healthcare industry impacted by the coronavirus and FDA’s focused efforts. Please read <a target="_blank" href="https://lifesciences.mofo.com/topics/FDA-working-to-address-2019-novel-Coronavirus-product-safety-part-I.html">Part I</a> of our series and <a href="https://lifesciences.mofo.com/topics/FDA-working-to-address-2019-novel-Coronavirus-supply-chain-part-II.html" target="_blank">Part II</a> of our series. The U.S. Secretary of Health and Human Services declared the novel 2019 coronavirus a U.S. public health emergency on Friday, January 31, 2020 and this determination was formalized pursuant to pursuant to section 564(b)(1)(C) of the Food Drug and Cosmetic Act on February 4, 2020. CDC developed a new laboratory test kit for use in testing patient specimens for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. The test kit is called the “Centers for Disease Control and Prevention (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel.” This test is intended for use with upper and lower respiratory specimens collected from persons who meet CDC criteria for COVID-19 testing. CDC’s test kit is intended for use by laboratories designated by CDC as qualified and, in the U.S., certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests. On Monday, February 3, 2020, CDC submitted an <a target="_blank" href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization" title="Emergency Use Authorization">Emergency Use Authorization</a> (EUA) package to FDA in order to expedite use of the CDC diagnostic panel in the United States.The EUA process enables FDA to consider and authorize the use of unapproved but potentially life-saving medical or diagnostic products during a public health emergency. FDA can issue an EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition when there is a declared public health emergency, such as currently in effect in the U.S. relating to COVID-19. On February 4, 2020, FDA granted the EUA request to the CDC, permitting use of the CDC test kit in labs certified to perform high complexity tests. FDA simultaneously developed an EUA review template for tests to detect the virus, which outlines the data requirements for a Pre-EUA package available to developers upon request. This revised template for these EUA submissions is available now on FDA’s website. FDA reports it has shared its EUA review template with more than 50 developers who have expressed interest in developing diagnostics for this virus.On February 25, 2020, the agency <a target="_blank" href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostics-testing-laboratories-certified-perform-high-complexity-testing-under-clia-prior" title="Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency">issued a new policy</a> for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the United States. The new policy authorizes certain laboratories to develop and begin to use validated COVID-19 diagnostics before the FDA has completed review of their EUA requests—allowing the immediate use of these tests and not requiring the laboratory to await FDA approval of the EUA. This emphasizes FDA’s public health role in the rapid detection of COVID-19 to assist in controlling community spread of the virus. Only laboratories certified under the <a target="_blank" href="https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia" title="Clinical Laboratory Improvement Amendments (CLIA)">Clinical Laboratory Improvement Amendments</a> to perform high complexity tests can take advantage of this unprecedented policy, and only after appropriate analytical validity testing is completed and documented by the laboratory. The new policy requires a laboratory taking advantage of this process to notify FDA of such usage and submit a complete EUA request to FDA within 15 days of the use of the test to detect COVID-19.Then, on February 29, 2020, FDA completed its review and authorized the EUA of Wadsworth Center, New York State Department of Public Health’s “New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel,” which is indicated for the presumptive qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs and sputa collected from individuals who meet CDC COVID-19 clinical and/or epidemiological criteria (for example, clinical signs and symptoms associated with COVID-19, contact with a probable or confirmed COVID-19 case, history of travel to a geographic locations where COVID-19 cases were detected, or other epidemiologic links for which COVID-19 testing may be indicated as part of a public health investigation). Testing is limited to the Wadsworth Center and certain authorized state and city laboratories. A <a target="_blank" href="https://www.fda.gov/media/135662/download">Fact Sheet for Health Care Professionals</a> details the use and limits of the test. Only one day after receiving the EUA approval, New York’s Wadsworth Center identified <a target="_blank" href="https://www.democratandchronicle.com/story/news/politics/albany/2020/03/01/new-york-has-first-case-coronavirus-here-details/4925681002/">New York’s first case of COVID-19</a> using its FDA EUA authorized RT-PCR Diagnostic Panel.FDA is also drawing on its vast public health expertise in providing regulatory advice, guidance and technical assistance to sponsors. Although media reports indicate a number of drug and vaccine firms are working toward medical products to address COVID-19, there are no FDA-approved vaccines or therapeutics to prevent or treat COVID-19. The National Institutes of Health began a <a target="_blank" href="https://www.niaid.nih.gov/news-events/nih-clinical-trial-remdesivir-treat-covid-19-begins">randomized controlled trial</a> for the treatment of COVID-19 patients. While sponsors are usually expected to allow 30 days between submission and initiation of an initial Investigational New Drug (IND) protocol to allow for safety review, FDA has been using both pre-IND discussions and highly expedited initial review to allow such trials to begin as soon as possible.

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FDA Working to Address 2019 Novel Coronavirus (COVID-19): Diagnosis & Treatment (Part III)

Federal Circuit Corrects USPTO on Reasonable Efforts When Calculating Patent Term Adjustment

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FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including 

FDA Working to Address 2019 Novel Coronavirus (COVID-19): Diagnosis & Treatment (Part III)

FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including product safety, monitoring supply chain disruptions, and supporting emergency efforts to diagnose and treat the disease. In addition, FDA is addressing safety concerns with its own workforce. In this three-part series, we explain FDA’s efforts in each of these areas and highlight the impact on different sectors of the healthcare industry impacted by the coronavirus and FDA’s focused efforts. Please read <a href="https://lifesciences.mofo.com/topics/FDA-working-to-address-2019-novel-Coronavirus-product-safety-part-I.html" target="_blank">Part I of our series</a>.FDA is anticipating that supply chain disruptions will occur as a result of the COVID-19 outbreak. In fact, FDA confirmed on February 27, 2020, that a drug manufacturer with a human drug product is now included on the <a href="https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm" target="_blank">drug shortages list</a> as a result of the impact of the outbreak on a site that is manufacturing the active pharmaceutical ingredient of the drug product. The COVID-19 outbreak follows shortly on the heels of FDA’s focused efforts last fall on drug shortage issues and, in October 2019, FDA issued a report, “<a href="https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions" target="_blank">Drug Shortages: Root Causes and Potential Solutions</a>,” that attempts to identify root causes and offer recommendations to help prevent and mitigate drug shortages.FDA has redirected agency resources to proactively communicate with drug and device firms that could be impacted by the outbreak. Since January 24, 2020, FDA has been in touch with more than 180 manufacturers of human drugs, not only to remind them of applicable legal requirements for notifying FDA of any anticipated supply disruptions, but also asking them to evaluate their entire supply chain, including active pharmaceutical ingredients (the main ingredient in the drug and part that produces the intended effects, e.g., acetaminophen) and other components manufactured in China. Also, as part of FDA’s proactive supply chain management efforts, they have identified about 20 other drugs, which solely source their active pharmaceutical ingredients or finished drug products from China and FDA has been in direct contact with those firms to assess whether they face any drug shortage risks due to the outbreak. Drug firms are required by law to proactively communicate drug shortage risks and also respond to FDA inquiries regarding management of drug supply issues.No law exists requiring medical device manufacturers to notify FDA when they become aware of a circumstance, including discontinuation of a product, that could lead to a potential shortage, and manufacturers are not required to respond when FDA requests information about potential supply chain disruption. FDA has identified 63 manufacturers which represent 72 facilities in China that produce essential medical devices and has proactively contacted these firms. FDA has confirmed that a number of these facilities are impacted by the outbreak, but is not reporting any medical device shortages in the U.S. market as of February 27, 2020. Despite reported challenges in obtaining personal protective equipment, such as respirators, gloves and masks, FDA is not reporting a shortage in the supply chain at this time. FDA has established a unique email box to receive information about device shortages: <a href="mailto:deviceshortages@fda.hhs.gov" target="_blank">deviceshortages@fda.hhs.gov</a> and is encouraging voluntary cooperation from device firms in assessing supply chain impacts.FDA also has a number of regulatory tools available, beyond the immediate surveillance and monitoring activities described above, to address the supply chain impact of the coronavirus outbreak. In addition, the President’s budget contains specific proposals that FDA is now emphasizing could help FDA address coronavirus supply chain disruption. First, FDA is strongly advocating that Congress update the legal authority regarding medical device supply chain disruption reporting and cooperation. Second, FDA advocates that it be able to obtain infrastructure information, such as manufacturing quality and capacity, in a proactive process. Third, FDA recommends that it be given the legal authority to require medical product firms (drugs and devices) to prepare and test against risk assessments of supply chain vulnerabilities and be required to maintain emergency contingency plans. Finally, FDA suggested that it should be granted the legal authority to require drug manufacturers to revise and lengthen expiration dates to the maximum date scientifically validated to address supply chain disruptions. We will continue to monitor these proposed changes to FDA’s legal authorities.