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.

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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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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.

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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 May 3, 2023, New York Governor Kathy Hochul signed into <a href="https://www.nysenate.gov/legislation/bills/2023/A3007" target="_blank">law</a> an amendment to the New York Public Health Law that will require certain healthcare entities to provide the State Department of Health (DOH) with written notice and supporting documentation of “material transactions” at least 30 days before closing. This new law will require healthcare entities, such as management service organizations, physician practices, and other similar entities, to submit notice and supporting documentation to DOH when engaging in mergers, acquisitions, and other transactions in New York. Here are four key points from the new law:1. How does the enacted legislation differ from the initial proposal? The original proposed legislation gave DOH broad authority to both review and approve material transactions and allowed DOH to define what transactions are material. See our previous blog post <a href="https://lifesciences.mofo.com/topics/states-extend-scope-of-regulatory-oversight-of-health-care-entities" target="_blank">here.</a> The enacted legislation pulls back on this authority and does not grant DOH the ability to approve transactions and also excludes “de minimis” transactions from review. De minimis transactions in this context are those that result in a healthcare entity increasing its total gross in-state revenues by less than $25 million.[1]2. Definition of “Material Transactions.” The law defines “material transactions” as any of the following:(1) a merger with a healthcare entity(2) an acquisition of one or more healthcare entities, including, but not limited to, the assignment, sale, or other conveyance of assets, voting securities, membership or partnership interest, or the transfer of control(3) an affiliation agreement or contract formed between a healthcare entity and another person(4) the formation of a partnership, joint venture, accountable care organization, parent organization, or management services organization for the purpose of administering contracts with health plans, third-party administrators, pharmacy benefit managers, or healthcare providers as prescribed by the commissioner by regulation.[2]3. Exclusions from Review. In addition to de minimis transactions mentioned above, the law excludes the following transactions from review: clinical affiliations of healthcare entities formed with the intent to facilitate collaboration between the entities (i.e., collaboration on clinical trials), transactions already subject to the Certificate of Need (CON) process, or an insurance entity approval process under the New York Public Health or Insurance Laws.4. Notice Requirements. The notice and review process will be further defined in regulations promulgated by DOH. Written notices must have information including, but not limited to, name and address of the transaction parties, copies of the definitive agreements, locations impacted by the transactions, closing date, and description of the purpose of the transaction, including anticipated impacts on cost, quality, and access in the impacted markets.[3] Upon receipt of a transaction notice, DOH will submit the notice to various bureaus of the Office of the New York Attorney General and post a summary of the proposed transaction on its website with an opportunity for public comment. 5. Noncompliance Consequences. DOH may impose a civil penalty of $2,000 for each day that a transaction is out of compliance. This penalty may be increased up to $5,000 for subsequent violations that pose a “serious threat to the health and safety” of individuals.[4] Each day that the violation continues is a separate violation and the penalty may extend until and unless a notice is filed.ConclusionAlthough the law is less onerous than what had been originally proposed, it does impose obligations on a broad array of entities, including management services organizations, in an attempt to monitor investments and other activities in the healthcare industry. [1] NY Pub. Health L. § 4550(4)(b).[2] NY Pub. Health L. § 4550(4)(a).[3] NY Pub. Health L. § 4552(1).[4] NY Pub. Health L. § 4552(4); NY Pub. Health L. § 12.

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220923-content

On May 3, 2023, New York Governor Kathy Hochul signed into law an amendment to the New York Public Health Law that will require certain healthcare entities to provide the State Department of Health (DOH) with written notice and supporting documentation of “material transactions” at least 30 days before closing. This new law will require healthcare entities, such as management service organizations, physician practices, and other similar entities, to submit notice and supporting documentation to DOH when engaging in mergers, acquisitions, and other transactions in New York. 

New York Enacts Material Healthcare Transactions Notice Requirements: Four Key Takeaways

Healthcare

Regulatory

United States

On April 13, 2023, the Federal Trade Commission (FTC) sent approximately 670 <a href="https://www.ftc.gov/system/files/ftc_gov/pdf/Substantiaton-NPO.pdf" target="_blank">notices of penalty offenses</a> to various companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, and functional foods, placing them on notice that they could incur significant civil penalties if they fail to adequately substantiate product claims. The <a href="https://www.ftc.gov/system/files/ftc_gov/pdf/Sample-cover-letter-substantiaton.pdf" target="_blank">cover letters</a> suggest that the recipients consult FTC staff’s recently issued <a href="https://www.ftc.gov/system/files/ftc_gov/pdf/Health-Products-Compliance-Guidance.pdf" target="_blank">Health Products Compliance Guidance</a>. The letter to the recipient companies also provides a copy of a <a href="https://www.ftc.gov/system/files/attachments/penalty-offenses-concerning-endorsements/notice-penalty_offenses-endorsements.pdf" target="_blank">previously approved notice of penalty offenses</a> regarding the use of endorsement and testimonials. Notices of penalty offenses allow the agency to seek civil penalties up to $50,120 per violation against companies that engage in conduct they know has been found unlawful in a previous FTC administrative order. The FTC warned that it will not hesitate to use its authority to target violators with large civil penalties. Companies receiving this warning from the FTC include companies that sell cosmetics, personal care products, food, drugs, devices, and dietary supplements.The FTC requires that companies substantiate product claims with reliable evidence. The Notice of Penalty Offenses Concerning Substantiation of Product Claims stated that the following acts or practices in the advertising and promotion of products are deceptive or unfair and unlawful under Section 5(a)(1) of the Federal Trade Commission Act:<ul><li>Making an objective product claim without having a reasonable basis at the time the claim is made consisting of competent and reliable evidence;</li><li>Making a claim regarding the health benefits or safety of a product without having as substantiation competent and reliable scientific evidence that has been conducted and evaluated in an objective manner by qualified persons, and that is generally accepted in the profession;</li><li>Representing expressly or implicitly that a product is effective in the cure, mitigation, or treatment of any serious disease (e.g., heart disease, cancer, arthritis, erectile dysfunction) without having and relying on at least one human clinical trial that (1) is randomized, (2) is well controlled, (3) is double-blinded (unless demonstrated that blinding cannot be effectively implemented given the nature of the intervention), (4) is conducted by persons qualified by training and experience to conduct such studies, (5) measures disease end points or validated surrogate markers, and (6) yields statistically significant result;</li><li>Misrepresenting the level of type of substantiation for a claim; and</li><li>Representing that a product claim has been scientifically or clinically proven unless, at the time of representation, the advertiser possesses and relies upon evidence sufficient to satisfy the relevant scientific community of the claim’s truth.</li></ul>The initial distribution of the notice is limited to those companies making health claims or those likely to make health claims considering their product types. However, the FTC stressed that the notice is not limited to health claims and will apply to any entity making claims about the efficacy or performance of its products. While it does not suggest a company has engaged in deceptive or unfair conduct, inclusion on the list demonstrates at the very least that the FTC is aware of the company and the company’s products.Morrison Foerster’s regulatory and class action litigation teams work seamlessly to advise clients on compliance and product claims. Please contact the authors if you have questions.

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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

Nature's Path Foods

Suja Juices

Unilever USA Inc.

Nature’s Path Foods and Sprouts Farmers Market

Iovate Health Sciences, International

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

Claudia Vetesi

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

Claudia M. Vetesi

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FTC Issues Notice of Penalty Offenses on Substantiation of Product Claims

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On April 13, 2023, the Federal Trade Commission (FTC) sent approximately 670 notices of penalty offenses to various companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, and functional foods, placing them on notice that they could incur significant civil penalties if they fail to adequately substantiate product claims. 

FTC Issues Notice of Penalty Offenses on Substantiation of Product Claims

Litigation

Morrison & Foerster is pleased to <a target="_blank" href="https://www.mofo.com/resources/news/200417-mofo-expands-corporate-capabilities.html">announce</a> the continued expansion of its New York office and global Corporate Department capabilities with the arrival of corporate partner Mitchell Presser. He joins the firm as a partner in its Mergers + Acquisitions and Private Equity Investments + Buyouts practices and will serve as co-chair of the firm’s Global Corporate Department.Mitchell Presser brings to the firm 30 years of experience in public and private mergers and acquisitions, with a heavy concentration on private equity transactions. Clients across wide-ranging sectors call on Mitchell for his vast experience, as both a lawyer and a principal, executing high-profile M&A and private equity transactions that lead to successful outcomes. He has worked across asset classes, including agriculture, food, financial services, industrials, insurance, sports and entertainment, energy and retail.Mitchell was previously a founding partner of Paine Schwartz Partners (formerly Paine & Partners), a leading U.S. private equity firm managing a $1.2 billion fund focused on investing in food and agriculture. Having served as an investor for more than eight years, Mitchell’s understanding of both the legal and business environments enables him to provide a unique perspective to clients.His joining Morrison & Foerster strengthens the firm’s already robust M&A and private equity global footprint and highlights the continued commitment to growth of the firm’s capabilities and growth in New York.<a target="_blank" href="https://www2.mofo.com/e/323401/people-mitchell-presser-html/5kcrn/164503921?h=gZLF55mZesojIu0CZhQ6YbogQbQXb_i0sgph26DVG0c">Mitchell Presser</a> Co-Chair, Global Corporate Department New York (212) 336-4432 <a href="mailto:mpresser@mofo.com">mpresser@mofo.com</a>

Paine Schwartz Partners

AgroFresh Solutions Inc.

Special New Fruit Licensing

Aqua Capital

Sugar Foods Corporation

Lyons Magnus

FoodChain ID

WireCo WorldGroup

Eurodrip

Tinicum

TSL Engineered Products

SoftBank Group Corp.

Project 8

Tene Capital and Pulse Agri Investments

Burford Capital

MSD Capital

Kinder Morgan

Pivotal Acquisition Corporation

Silver Crest Acquisition Corporation

Sky Harbour LLC

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Mitchell Presser advises on high-profile global public and private mergers and acquisitions, with a heavy concentration on private equity transactions.

Mitchell S. Presser

Mitchell Presser

Morrison & Foerster Expands Corporate Capabilities Adding New Corporate Co-Chair Mitchell Presser

Morrison & Foerster Expands Corporate Capabilities Adding New Corporate Co-Chair Mitchell Presser

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Morrison & Foerster is pleased to announce the continued expansion of its New York office and global Corporate Department capabilities with the arrival of corpo

Corporate + Venture Capital

Agtech

Last month, Dr. Stephen Hahn was officially sworn in as the new commissioner of the U.S. Food and Drug Administration (FDA). The Senate confirmed him by a 73-17 vote. Hahn became the fourth leader of FDA in 2019 and the first confirmed nominee since former Commissioner Dr. Scott Gottlieb resigned unexpectedly in April and was followed by two temporary acting commissioners. Under a permanent commissioner, we will likely see more consistent and future-oriented policy agendas and programs, but the 2020 presidential election may threaten Hahn’s extended tenure as commissioner—a position nominated by the president with no fixed term. Hahn will most likely be compared to Dr. Gottlieb, the well liked and effective communicator. Hahn’s specific strategies and goals for the agency are not yet clear, but his experience as a researcher, practitioner, and administrator will give him valuable insight to take on the issues currently facing FDA. With a specialization in radiation oncology, he was most recently the Chief Medical Executive at the University of Texas M.D. Anderson Cancer Center, which has over 20,000 employees, runs on an annual budget of over $5 billion, and currently ranks as the top cancer center in the United States. Hahn earned respect as a skilled leader after becoming Chief Operating Officer of M.D. Anderson in 2017. At the time, the medical center was suffering major financial losses, but it became profitable merely months after Hahn stepped into the role. Before that, he was a professor, research director, and chief of the Radiation Oncology Department at the University of Pennsylvania Perelman School of Medicine. Hahn has also treated patients as a clinician. Despite his familiarity with running a large healthcare organization, he has never worked in government and his regulatory philosophy is largely unknown. He also has no notable ties to large pharmaceutical companies—a concern raised during Gottlieb’s confirmation process in 2017.Already on Hahn’s future agenda is teen vaping, which has garnered extensive media and government scrutiny due to a rising number of vaping-related illnesses and deaths. Although e‑cigarette products have been targeted by proposed state and federal legislation, they also fall under FDA’s regulatory authority. During his confirmation hearing before the Senate Health, Education, Labor and Pensions (HELP) Committee, Hahn was questioned extensively about his position on a potential ban of flavored tobacco products. The Trump administration proposed the ban on flavored e‑cigarettes earlier this year, but retreated from implementing it before finally settling on a compromise position of banning some but not all flavored e-cigarette cartridges. Despite calling teen tobacco use an “urgent crisis in this country” and saying that “aggressive action needs to be taken to protect our children,” Hahn was similarly noncommittal to the ban. The cancer doctor’s refusal to take a clear stance on the issue led some committee members to question whether Hahn will remain objective against pressure from President Trump and industry lobbyists.In addition to e‑cigarette use, the HELP Committee expressed concerns about generic drug approval and availability, FDA’s framework for assessing cannabidiol‑based medical products, and ongoing management of the opioid crisis. Hahn’s approach to those issues remains to be seen, but he has promised to use “science and data” to guide his decisions as the next FDA Commissioner. Gottlieb, still a prominent voice in the industry, has continued to criticize the current CBD supplement and beverage industry, outside FDA. We will continue to monitor and report on Commissioner Hahn’s impacts on the regulatory landscape alongside other novel FDA regulation and compliance issues, and expect 2020 to be an exciting year as we all get to know him and understand his approach and priorities.

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 Y. Park

2020 Under Dr. Stephen Hahn, FDA’s New Commissioner