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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Morrison Foerster's patent prosecution and patent strategy team is highly qualified with more than 100 advanced degrees and multilingual capabilities.

With 80+ Ph.D.s, more than 100 advanced degrees, and multi-lingual capabilities, including Chinese and German, we offer clients around the world a patent prosecution and counseling practice that is unrivaled in its depth of industry and technical experience.

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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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Our life sciences and healthcare clients, from emerging innovation drivers to iconic brands, rely on our unrivaled depth of knowledge and technological experien

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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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USPTO Discontinues Accelerated Examination Program in Favor of Expanding Track One Program

Subject Matter Eligibility of AI Medical Treatments

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

Federal Circuit Vacates and Remands in Long-Pending Dispute over CRISPR IP

The Future of Food: Exploring the World of Cell-Cultivated Cuisine (Blog Post)

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On February 2, 2023, the Principal Deputy Assistant Attorney General for the U.S. Department of Justice’s (DOJ) Antitrust Division, Doha Mekki, announced that the DOJ was withdrawing three policy statements outlining safe harbors for information sharing in the healthcare industry, and suggested that DOJ’s increased scrutiny of information sharing will extend to other industries. Mekki explained that the DOJ was working with the Federal Trade Commission (FTC) to withdraw all three policy statements, each of which was jointly issued by the agencies, and they followed through with that promise on February 3, 2023.Read the <a href="https://www.mofo.com/resources/insights/230206-doj-increase-antitrust-scrutiny-information-sharing" target="_self">full client alert</a>.

DOJ Signals Intent to Increase Antitrust Scrutiny of Information Sharing

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Co-chair Global Antitrust Law Practice Group

Alex Okuliar is Co-Chair of Morrison Foerster’s Global Antitrust Law Practice Group. He is the former Deputy Assistant Attorney General for Civil Antitrust Enforcement at the U.S. Department of Justice and a former advisor at the Federal Trade Commission.

Alexander Okuliar

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Lisa M. Phelan, former Chief of the National Criminal Enforcement and Washington Criminal I Sections of the Antitrust Division of the U.S. Department of Justice (DOJ), is a partner and Co-Chair of Mo

Lisa M. Phelan

Lisa Phelan

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Joseph Folio is a trial lawyer and partner in Morrison Foerster’s Global Antitrust Law, Crisis Management, and Privacy + Data Security Groups, with more than a dozen years of experience leading complex government investigations and high-profile litigation.

Joseph Charles Folio III

Joseph Folio III

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Associate

Margaret Webb is a Litigation associate in the firm’s San Francisco office. Her practice focuses on complex commercial disputes, as well as civil, criminal, and internal investigations.
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Margaret A. Webb

Margaret Webb

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DOJ Signals Intent to Increase Antitrust Scrutiny of Information Sharing

On February 2, 2023, the Principal Deputy Assistant Attorney General for the U.S. Department of Justice’s (DOJ) Antitrust Division, Doha Mekki, announced that the DOJ was withdrawing three policy statements

Healthcare

Litigation

Antitrust

United States

On December 20, 2022, the Federal Trade Commission (FTC) issued its <a href="https://www.ftc.gov/system/files/ftc_gov/pdf/Health-Guidance-508.pdf" target="_blank">Health Products Compliance Guidance</a> (“Health Products Guidance”). This is the first update in nearly 25 years to FTC’s guidance regarding advertising claims for dietary supplements, foods, over-the-counter drugs, and other health-related products. The update draws on the over 200 new cases since the last guidance was published to illustrate potentially false and misleading claims and proper claim substantiation. Key updates and changes include:<ul><li>23 new examples to broaden the guidance to cover foods, over-the-counter drugs, devices, and other health-related products;</li></ul><ul><li>Clarification of FTC’s coordination with the Food and Drug Administration (FDA) regarding health product claims;</li><li>Detailed guidance on FTC’s standards for proper “clear and conspicuous” disclosure of claim qualifications; and</li><li>Expanded discussion on the required “competent and reliable scientific evidence” and testing methodology required to substantiate health-related claims.</li></ul>I. FTC AND FDA – JURISDICTION AND COOPERATIONFTC and FDA both have jurisdiction over marketing of dietary supplements, foods, non-prescription drugs, devices, and other health-related products. The agencies signed a <a href="http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm115791.htm" target="_blank">memorandum of understanding</a> that clarifies FDA has primary responsibility for labeling claims (“including the package, product inserts, and other promotional materials available at point of sale”) and FTC has primary responsibility for advertising claims (“traditional TV, radio, print, and internet ads, but also more broadly to [a] variety of marketing techniques and promotion methods”). But as explained in the Health Products Guidance, the agencies may regulate the same type of claims for the same type of product differently. For example, while FDA evaluates a claim differently depending on whether the product is a supplement, food, or drug, FTC treats all health product claims the same. Unlike FDA, FTC does not pre-approve health claims or require notification for structure/function claims. And while FTC gives great deference to claims that FDA has endorsed, an FDA assessment is not dispositive of whether a claim may be deceptive according to FTC.II. FTC’S EVALUATION OF HEALTH-RELATED PRODUCT ADVERTISINGThe Health Products Guidance outlines FTC’s two-step process for evaluating the truthfulness and accuracy of advertising of dietary supplements, foods, over-the-counter drugs, and other health-related products. The first step of the process is to “identify all claims the advertising materials communicate to reasonable consumers.” The second step is “FTC assesses the scientific evidence upon which the company relies to determine whether there is adequate support for those claims.” Examples throughout the Health Products Guidance help illustrate how FTC applies these standards to claims and advertising.Step One: Identifying and Interpreting Claims and AdvertisementsWhen identifying and interpreting advertising claims, FTC focuses on the consumer’s understanding of an advertisement rather than the marketer’s intent because the intended audience may have special attributes that render them more susceptible to certain claims. For example, “terminally ill consumers might be particularly susceptible to exaggerated cure claims.” The Health Products Guidance explains that deceptive advertising may arise from either: (1) direct or implied claims about the benefits, safety, or other characteristics of the product, or (2) omitted information that “is material in light of the claims in the ad or with respect to how consumers would customarily use the product,” such as not indicating that a vitamin may cause fatigue.When disclosure of material information is necessary to prevent advertising from being false or misleading, the disclosure must be “clear and conspicuous.” In other words, mere inclusion of qualifying information is insufficient, and to prevent an ad from being deceptive, advertisers should ensure that a written disclosure is “easily noticed, read, and understood” and that an audible disclosure is “delivered in a volume, speed, and cadence so that it can be easily heard and understood.” Ultimately, whether a disclosure is sufficiently clear and conspicuous depends on whether it has an effective impact on a reasonable consumer.Step Two: Evaluating Claim SubstantiationFTC’s updated guidance dives deep on its second step in evaluating an advertisement’s truthfulness: whether a health product claim is properly substantiated with “competent and reliable scientific evidence.” When evaluating whether the advertiser has a reasonable basis to make a claim, FTC considers the following five factors.<div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltf85bc77f18179737/63d97ed3ca59cf11374cf0c6/230130-ftc-issues-graph.jpg?format=auto&amp;quality=60" alt="life science chart"/></div>Under this framework, FTC generally requires randomized, controlled human clinical trials for most health benefit claims because they are needed to prove a causal link, but may make some exceptions where experts in the field accept alternative substantiation and human clinical trials are not feasible. The Health Product Guidance explains that to serve as adequate substantiation, a reliable, quality clinical trial should generally include randomization, a control group, double blinding, statistically significant results, and clinically meaningful results, among other characteristics.But the totality of the evidence must be considered in the context of the available scientific evidence in the applicable field and the actual claim being made. An individual study supporting a claim is not enough to make a claim truthful if the surrounding evidence in the field runs contrary to the study.III. OTHER ADVERTISING ISSUESThe Health Product Guidance also discusses five distinct health product advertising issues that may draw FTC scrutiny.<ol><li>Consumer testimonials or expert endorsements.FTC cautions against claims based on consumer testimonials or expert endorsements, unless those claims can be substantiated, as the advertiser is ultimately responsible for the misleading use of an endorsement.</li><li>Traditional use claims. Claims based on traditional use, such as an advertisement that indicates an herbal tea mixture has been used to aid digestion for hundreds of years, are not per se acceptable, and will be considered misleading if such claims are not substantiated.</li><li>DSHEA disclaimers. Mere use of the Dietary Supplement Health and Education Act (DSHEA) disclaimer stating that the product has not been evaluated by FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease will not cure an otherwise deceptive advertisement or claim.</li><li>FDA oversight.Advertisers should be mindful “not to mischaracterize the extent to which a product or claim[GJL1]  has been reviewed, authorized, or approved by the FDA.”</li><li>Third-party literature. FTC will evaluate whether reference to third-party literature may constitute an implied and deceptive claim on a case-by-case basis.</li></ol>Advertisers of health-related products must be especially diligent about what claims they are making. Both FTC and FDA have jurisdiction over this area and both agencies have increased enforcement efforts in recent years for false and misleading claims. And as FTC’s updated Health Products Guidance demonstrates, advertising for health-related products must be nuanced and thoughtfully considered to avoid potential pitfalls that could lead to regulatory enforcement and litigation.Kai Mindick, a former law clerk in our Austin office, contributed to the writing of this post.

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

Fitbit

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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.

Julie Park

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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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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Matt is an associate in the Litigation Department in MoFo’s San Diego office. Matt’s practice focuses on the product lifecycle, from early product development to litigation to end-of-life advisement. He counsels clients through complex consumer product safety regulatory landscapes and product recalls.











Matt Robinson

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FTC Issues Updated Health Products Claims Guidance

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On December 20, 2022, the Federal Trade Commission (FTC) issued its Health Products Compliance Guidance (“Health Products Guidance”). This is the first update in nearly 25 years to FTC’s guidance regarding advertising claims for dietary supplements, foods, over-the-counter drugs, and other health-related products. The update draws on the over 200 new cases since the last guidance was published to illustrate potentially false and misleading claims and proper claim substantiation. Key updates and changes include:

FTC Issues Updated Health Products Claims Guidance

Regulatory

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Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post.UPDATE: The Executive Office of the President announced on January 30, 2023, that the current administration plans to terminate the PHE declaration on May 11, 2023. <a href="https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf" target="_blank">This announcement</a> does not change the COVID testing policies discussed below.The U.S. Food & Drug Administration (FDA) issued two new versions of guidance documents for COVID-19 tests on January 12, 2023: <a href="https://www.fda.gov/media/135659/download" target="_blank">Policy for Coronavirus Disease-2019 Tests</a> (the “COVID-19 Test Guidance”) and <a href="https://www.fda.gov/media/146171/download" target="_blank">Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests</a> (the “Viral Mutations Guidance”).  The COVID-19 Test Guidance supersedes its last version issued on September 27, 2022, and the Viral Mutations Guidance supersedes its first version issued on February 22, 2021.  FDA issued these guidance documents the day after the U.S. Department of Health & Human Services (HHS) Secretary most recently renewed the <a href="https://aspr.hhs.gov/legal/PHE/Pages/default.aspx" target="_blank">section 319 Public Health Emergency declaration for COVID-19</a> (the “PHE declaration”) on January 11, 2023.  The PHE declaration will expire in April 2023 unless the HHS Secretary terminates it earlier or renews it for another 90 days.Both of the new versions of the guidance documents were updated so they will remain in effect for the duration of the <a href="https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency" target="_blank">section 564 Emergency Use Authorization declaration for COVID-19 In Vitro Diagnostics</a> (the “EUA declaration”), regardless of the status of the PHE declaration.  The updates are a departure from the previous versions, both of which were to last only for the duration of the PHE declaration and may be a signal that FDA is preparing for an earlier ending of the PHE declaration.Other than the update to its duration, the COVID-19 Test Guidance was not significantly changed.  The COVID-19 Test Guidance now states that FDA intends to review the Emergency Use Authorization (EUA) requests for a “small” subset of tests, which is technically an update from the reference to a “smaller” subset of tests in the previous version.  However, the general review prioritization criteria including “likely to have a significant public health benefit” and “likely to fulfill an unmet need” remain the same.Similarly, the Viral Mutations Guidance was not significantly updated.  The Viral Mutations Guidance expressly notes that the “recommendations and policies” have not been revised from the previous version, while providing updated information on (i) the U.S. government’s designation of the omicron variant as a variant of concern on November 30, 2021 (section II); (ii) FDA’s efforts to evaluate the impact of new virus variants on tests authorized or cleared under the de novo or 510(k) pathway, as well as those under an EUA (section II); and (iii) FDA’s new web page <a href="https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests" target="_blank">SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests</a> (sections II and IV).One notable change to the Viral Mutations Guidance, however, is that some of its recommendations now expressly apply to marketing submissions such as a de novo or 510(k) submission, as well as an EUA request, for a COVID-19 test.  Section IV of the guidance provides that the following considerations will apply to both marketing and EUA submissions for COVID-19 tests: (i) performance validations across all known variants; (ii) developers’ plans for post-authorization monitoring; and (iii) inclusion of statements and limitations related to virus variants in the labeling.Overall, the updates to the two guidance documents seem to further reflect FDA’s preparation for an end to the PHE declaration and transition into full marketing authorizations and clearances of COVID-19 tests.

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FDA Updates COVID-19 Testing Guidances

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FDA Updates COVID-19 Testing Guidances