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Navigating U.S. Regulatory Requirements for Genetically Modified Microorganisms Using Interactive Tool

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Under the U.S. Coordinated Framework for the Regulation of Biotechnology, the U.S. Department of Agriculture (USDA), U.S....

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We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.

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Under the U.S. Coordinated Framework for the Regulation of Biotechnology, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) are the three primary agencies for regulation of plants, animals, and microorganisms derived from biotechnology. As part of an effort to modernize the Coordinated Framework spurred by a 2019 Executive Order, these agencies have released a web-based tool to help researchers and developers navigate the regulatory landscape for genetically modified (GM) organisms. Through a series of interactive prompts, the tool provides guidance on the applicable regulatory requirements for a GM microorganism.Read the <a href="https://lifesciences.mofo.com/topics/navigating-u-s-regulatory-requirements-for-genetically-modified-microorganisms-using-interactive-tool" target="_blank">full blog post</a>.

Navigating U.S. Regulatory Requirements for Genetically Modified Microorganisms Using Interactive Tool

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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.As the lead 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

Brian P. Sylvester is a partner in our FDA & Healthcare Regulatory and Compliance Group. He is the head of Food Regulatory and an influential thought leader and practitioner in the field of food regulation.Brian counsels clients across the full life cycle of regulated products, serving global brands, startups, life sciences companies, investors, and trade associations. He has been recognized by a number of legal industry awards and publications such as Chambers USA, Bloomberg Law, and The National Law Journal. Chambers USA reports that Brian “is widely noted as an expert in regulatory issues relating to novel food technologies, with significant experience advising on USDA and FDA regulations.”Brian focuses his practice on Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) regulated products, with an emphasis on the food and beverage sector. He additionally counsels early-stage, growth, and global clients on all aspects of cosmetics, over the counter (OTC) human drugs, medical devices, animal food and drugs, and a range of Animal and Plant Health Inspection Service (APHIS) regulated commodities. Across all these regulated product categories, his work spans enforcement actions, audits and investigations, regulatory compliance, labeling and advertising, import and export, due diligence, consumer litigation, comment preparation, public policy advocacy at the federal and state levels, and new product development.In the area of food and beverage, Brian develops regulatory strategies to commercialize a range of food tech innovations, including transgenic crops and alternative proteins, such as cultivated meat and fermentation-derived food ingredients, among others. As a former regulator at USDA, he adeptly counsels clients on strategic considerations around engagement with and advocacy before USDA and FDA on numerous complex issues, including those of first impression.Brian is an author and frequent speaker at industry-leading events in the United States, the European Union, China, Israel, and other parts of the world. He is regularly called upon to offer insights on trending legal issues by preeminent industry and global publications.

Brian Sylvester

Dr. Edith Pierre-Jerome focuses her practice on patent drafting and prosecution in areas related to molecular and cellular biology, biochemistry, microbiology, and plant genetics.Edith has more than 10 years of experience as a plant molecular biologist investigating gene regulation. Prior to joining MoFo, she was an HHMI Postdoctoral Research Fellow at Duke University in the lab of Dr. Philip Benfey. She was awarded a postdoctoral fellowship from the Life Sciences Research Foundation for her creative and innovative research in the nascent field of plant synthetic biology.Edith earned her Ph.D. in biology from the University of Washington, Seattle where she was an ARCS Foundation Scholar and an NSF Graduate Research Fellow. Her doctoral research in the lab of Dr. Jennifer Nemhauser used genetic engineering to successfully reconstruct the auxin signaling pathway from Arabidopsis in yeast. She earned her B.S. in genetics and plant biology and her B.A. in art history from the University of California, Berkeley.