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FDA Clears Crispr-Edited Cattle for Market Through Abbreviated Procedure: A First for Food-Use Animals

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On March 7, 2022, the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA) determined that Acceligen Inc.’s genome-edited, heat-tolerant cattle, pose a “low risk to humans, animals, the food supply, and the environment.” This is the first such determination for a genetically engineered food-use animal and will allow the company to bypass many of the usual premarket approval requirements.



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On March 7, 2022, the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA) determined that Acceligen Inc.’s genome-edited, heat-tolerant cattle, pose a “low risk to humans, animals, the food supply, and the environment.” This is the first such determination for a genetically engineered food-use animal and will allow the company to bypass many of the usual premarket approval requirements.Read the <a target="_blank" href="https://lifesciences.mofo.com/topics/fda-clears-crispr-edited-cattle-for-market-through-abbreviated-procedure-a-first-for-food-use-animals.html">full blog post</a>.

FDA Clears Crispr-Edited Cattle for Market Through Abbreviated Procedure: A First for Food-Use Animals

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Dr. Liz Freeman Rosenzweig focuses her practice on patent prosecution and intellectual property and regulatory counseling in the areas of life sciences and agricultural biotechnology, including AgTech; algae; environmental incentives such as carbon credits; crop science; gene editing; genetics; GM/GE plants; molecular biology; plant breeders’ rights/plant variety protection; plant breeding; plant IP; and soil technologies.Prior to joining the firm as an associate, Dr. Freeman Rosenzweig was a summer associate, a law clerk, and a scientific analyst intern at Morrison & Foerster, where she drafted office action responses for foreign and domestic patent applications, amended claims, drafted domestic utility and plant patent applications, and analyzed freedom to operate agreements.Liz earned her J.D. from the University of California, Berkeley, School of Law. At Berkeley Law, Liz was an associate editor of the Berkeley Technology Law Journal, in which she published “<a href="https://btlj.org/2022/01/volume-35-issue-4/" target="_blank">A Framework for Patent Exhaustion of Self-Replicating Technologies</a>”. She was also vice president of Faculty Relations for the Patent Law Society; she also earned a Law & Technology Certificate from the Berkeley Center for Law & Technology. Prior to law school, she received her Ph.D. in plant cell and molecular biology from Stanford University, where her doctoral research focused on high-efficiency carbon fixation in green algae. Her doctoral work was published in and featured on the cover of Cell. At Stanford, she designed and conducted experiments in algal cell biology using genetic engineering, recombinant protein design, fluorescent biosensors, quantitative confocal microscopy, and computational image analysis. Liz obtained her A.B. in biology magna cum laude from Washington University in St. Louis, with a focus in biochemistry and a minor in Modern Hebrew.

Liz Freeman Rosenzweig

Associate

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.As a member of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics, dietary supplements, tobacco, laboratory-developed tests, in vitro diagnostics, radiation-emitting electronic products, combination products, and products that may not fit neatly into any of these categories. Accordingly, she counsels established and start-up companies in life sciences, healthcare, and consumer products on a wide range of FDA pre- and post-market regulatory issues. Brigid also frequently advises innovative product developers on threshold FDA jurisdictional questions and develops strategies for approval and marketing, while identifying and mitigating regulatory risks.In her day-to-day practice, Brigid advises on:<ul><li>product development and FDA’s pre-authorization requirements;</li><li>advertising and promotion of FDA-regulated products;</li><li>clinical trials regulation, including strategic advice for sponsors in receipt of a clinical hold;</li><li>responses to warning letters, Form 483s, import alerts, and FDA enforcement actions;</li><li>informal and formal dispute resolution for high-stakes issues;</li><li>compliance with FDA regulatory requirements such as current good manufacturing practice (GMP), quality system regulation (QSR), food safety preventive controls, adverse event reports, product recalls, radiological health issues, risk evaluation and mitigation strategies (REMS), pharmacy compounding and the new track-and-trace regulations for prescription drugs; and</li><li>technical legal questions involving the Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), Federal Advisory Committee Act (FACA), Freedom of Information Act (FOIA), and the Administrative Procedure Act (APA).</li></ul>Brigid also has experience in the development, regulation, and procurement of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases, including animal rule approvals and special incentives for the development of MCMs.Complementing her focus on FDA regulatory law, Brigid has a strong litigation background and has served as FDA counsel in product liability cases, civil litigation, international arbitration, and FDA enforcement proceedings. She particularly enjoys providing clients with advice that integrates technical, legal, and political considerations.Brigid maintains an active pro bono practice focused primarily on reproductive health and especially enjoys working with inventors who aim to improve health outcomes for mothers and infants in the peri- and post-natal period. She has represented several clients before the Social Security Administration in appealing denials of applications for disability benefits. She has also worked on several appeals in criminal cases in the District of Columbia.Brigid is a graduate of the University of Tulsa, where she earned her B.S. in biochemistry before attending law school at Stanford Law School. Prior to law school, Brigid worked as an Environmental Policy Analyst in the Office of the Secretary at the U.S. Department of Transportation. She has also worked as a benchtop scientist in a number of laboratories, including FDA’s National Center for Toxicological Research.<h4>Representative Experience</h4><ul><li>Counseled online marketplaces regarding FDA compliance and enforcement for a variety of products.</li><li>Advised development-stage companies on regulatory considerations and FDA engagement strategies related to development and launch of products based on disruptive technologies.</li><li>Advised consumer technology companies with respect to potential FDA regulation under the medical device provisions of the FDCA;</li><li>Served as FDA regulatory counsel to clients evaluating compliance issues under reporting provisions of Corporate Integrity Agreements and related negotiated resolutions of government investigations.</li><li>Helped a large, publicly traded drug company comply with the FDA’s new track-and-trace pedigree requirements for prescription drugs.</li><li>Led regulatory team on numerous initial public offerings (IPO), stock and asset purchase agreements, acquisitions, mergers, and other transactions for life science company.</li><li>Provided strategic advice, conducting regulatory assessments and negotiating key FDA-related terms in connection with due diligence for transactions and post-acquisition integration activities.</li><li>Developed policy positions related to FDA regulation of laboratory-developed tests (LDTs) for multiple clients in this space.</li><li>Represented manufacturers in matters involving regulatory letters, inquiries, advisory comment proceedings, competitor complaints and citizen petitions focused on their products and policy issues affecting their strategic priorities.</li><li>Advised on issues related to promotion of drugs and medical devices, including communication of pharmacoeconomic/healthcare economic information (HCEI), communications by medical science liaisons (MSLs).</li><li>Provided solutions-oriented advice to development-stage companies confronting FDA regulatory issues for the first time, including good clinical practices (GCP), investigator-initiated research (IIR), pre-approval communications and strategies for obtaining FDA approval.</li><li>Collaboratively advised client on FDA, ethical, and product liability issues associated with early termination of a clinical study involving an implanted medical device.</li></ul>

Brigid Bondoc

Partner

Owen counsels clients in the life sciences, healthcare, food, and agriculture industries on cross-cutting issues involving regulatory compliance, intellectual property, and litigation.Owen earned his J.D. from Harvard Law School, where he edited the Harvard Journal of Law & Public Policy and worked with Harvard’s Center for Health Law and Policy Innovation’s Food Law and Policy Clinic on government strategy and policy projects affecting public health.Prior to law school, Owen studied neuronal degeneration and repair in genetically engineered zebrafish using time-lapse confocal fluorescence microscopy and computational image analysis. Owen studied genetics and genomics at UC Davis and received a B.A. in philosophy from UCLA, where he was elected to Phi Beta Kappa.Owen is admitted to practice in California and before the U.S. Patent and Trademark Office.<h4>Representative Experience</h4>Healthcare Regulatory<ul><li>Advised a software company, one of the largest providers of health information technology services, regarding fraud waste and abuse prevention, interactions with pharmaceutical and medical technology manufacturers, and federal payor compliance.</li><li>Advised a technology company regarding corporate practice of medicine laws and provided a regulatory landscape analysis for its AI-driven health and wellness chatbots.</li><li>Advised a multinational technology company regarding product rollout for direct access testing.</li><li>Advised a global advocacy organization regarding state telemedicine laws, licensing and scope of practice issues, and REMS compliance. </li></ul>FDA Regulatory<ul><li>Advised a large-cap pharmaceutical company in connection with its acquisition of a biopharmaceutical company regarding clinical trials regulation, in vitro diagnostic regulation, and advertising and promotional issues.</li><li>Advised a multinational retail company regarding implementation of a digital food traceability and tracking system.</li><li>Provided regulatory and litigation support to a specialty pharmaceutical company regarding pharmacy compounding regulations. </li><li>Advised a private equity firm in its purchase of a logistics company regarding the warehousing and transportation of food, drugs, and medical devices.</li></ul>Intellectual Property<ul><li>Litigated a patent infringement and antitrust dispute in federal court and before the U.S. Patent Trial and Appeal Board regarding self-administered collection devices used for genetic testing and molecular diagnostics.</li><li>Litigated a patent infringement dispute in federal court and before the U.S. Patent Trial and Appeal Board regarding cancer diagnostics and liquid biopsy.</li><li>Advised an early-stage agri-food technology company in connection with a research collaboration with a public university. </li><li>Advised a biopharmaceutical company regarding controlled substance registrations and intellectual property strategy.</li></ul>

Owen Hosseinzadeh

Food + Agriculture

Life Sciences + Healthcare

FDA + Healthcare Regulatory and Compliance