The U.S. Food and Drug Administration (“FDA”) regulates pharmaceutical products under a highly complex legal framework intended to ensure that companies market products that are safe and effective. The research and development, manufacturing, approval, labeling, marketing, import and export, and distribution of pharmaceuticals in the United States are regulated primarily under the Federal Food, Drug, and Cosmetic Act (“FDCA”).
The approval requirements under the FDCA and the implementing regulations issued by FDA reflect a careful balance of policy and science that encourages the development of new pharmaceuticals while also providing a pathway for low-cost generic products. Regardless of whether it is a brand-name or generic product, manufacturers must ensure that their products are manufactured in accordance with FDA’s current Good Manufacturing Practice (“cGMP”) requirements, which are enforced through FDA inspections. Often, the regulatory framework governing pharmaceuticals must balance competing tensions, such as FDA’s regulation of pharmaceutical advertising and promotion and a manufacturer’s First Amendment rights.
This course provides an introduction to the regulation of pharmaceuticals by FDA. It reviews approval requirements for brand-name and generic products, advertising and promotion issues, and pharmaceutical manufacturing issues in a global environment. Join Susan Lee, Jim Johnson and Gary Veron, partners in the Pharmaceutical and Biotechnology practice group in the Washington, D.C. office of Hogan Lovells, for this discussion.
Know the regulatory framework governing the approval of brand-name and generic pharmaceutical products
Understand compliance and enforcement risks associated with the manufacturing of pharmaceutical products in a global environment
Grasp the basic tenets of pharmaceutical advertising and promotion
Discuss recent developments in FDA’s regulation of pharmaceuticals
Positioned at the forefront of FDA compliance and regulatory issues critical to the business of life science companies, Jim Johnson excels at knowing what's ahead.
He works with life science clients on U.S. Food and Drug Administration (FDA) compliance and enforcement matters, focusing on FDA inspections, current good manufacturing practice (GMP) requirements, data integrity responsibilities, import and export issues, and pharmacovigilance obligations. He helps clients around the world identify compliance risks early, prevent problems from happening, efficiently resolve issues with minimal corporate pain, and improve agency relationships.
Jim knows the FDA well. Prior to joining Hogan Lovells, he served as Associate Chief Counsel for Enforcement in the FDA's Office of the Chief Counsel. He handled GMP enforcement and provided legal counsel on a range of inspectional and compliance issues to agency components, particularly the FDA's Office of Regulatory Affairs (ORA) and Center for Drug Evaluation and Research's (CDER) Office of Compliance.
Whether preparing an international manufacturing site for an FDA inspection, or working with a U.S.-based facility in response to FDA inspectional observations (a Form FDA 483), Jim uses his extensive agency and private practice experience to assist pharmaceutical, biotechnology, and cosmetic companies worldwide. He regularly conducts GMP assessments and investigations, resolves warning letters and import alerts, and appears in front of the FDA on behalf of companies to resolve enforcement actions.
Jim also advises life science companies on drug approval and life-cycle management strategies, and represents clients in related litigation against the FDA and U.S. Patent and Trademark Office. Jim honed these skills at the FDA, where he defended the agency in Hatch-Waxman cases involving agency exclusivity and patent-term extension determinations.
Prior to practicing law, Susan S. Lee served as both a vice president for economic policy at a Washington, D.C. policy institute and as a consultant and manager at a premier global management consulting firm, where she provided strategic business advice to innovative life sciences and healthcare companies.
Today, she applies her prior economic and business experience to advise life sciences companies with an approach that is legally rigorous, but also pragmatic and grounded in a solid understanding of each client's business objectives and corporate dynamics.
Susan focuses on the U.S. Food and Drug Administration's (FDA) regulation of drugs and biological products. She addresses legal issues involving advertising and promotion; interactions with healthcare professionals and payers; and regulatory issues that arise in acquisitions, collaborations, and other types of transactions.
Susan has reviewed promotional and medical information materials in numerous therapeutic areas, served on promotional review committees, and reviewed and drafted policies and procedures. She has also conducted internal investigations and audits, developed and delivered compliance training, and defended companies under government investigation.
In addition, Susan identifies potential approval pathways for products under development, helps clients prepare for interactions with FDA, and guides clients in emerging areas such as digital health. In her transactional practice, she conducts and supports regulatory due diligence; develops definitions, representations, and warranties for agreements; and advises companies on appropriate regulatory disclosures in SEC filings.
Susan graduated from Harvard College summa cum laude, where she studied neurobiology, and from Harvard Law School, where she was a member of the Board of Student Advisers.
From the laboratory to the marketplace, Gary Veron advises pharmaceutical and biotechnology companies on the wide range of U.S. Food and Drug Administration (FDA) issues that arise during drug development and commercialization. In particular, Gary focuses on Hatch-Waxman Act and life cycle management issues.
As a registered patent attorney, Gary has vast experience handling issues that occur at the intersection of FDA and intellectual property laws. He draws on his unique background to counsel clients regarding comprehensive development strategies, including market exclusivity periods, Orange Book issues, and therapeutic equivalence determinations. Gary's practice includes the novel issues raised by biosimilar and 505(b)(2) applications.
Gary also has experience negotiating technology transfer and license agreements and managing patent prosecution matters. Before joining Hogan Lovells, Gary practiced food and drug law and patent law at another international law firm and was a Technology Development Specialist at the National Institutes of Health (NIH), where he served as the intellectual property manager for four NIH institutes.
Gary is a "Recommended Lawyer" in Legal 500 USA, and is listed in The Best Lawyers in America (FDA Law).
EXCELLENT AND INFORMATIVE
An area where I have a lot to learn. Thanks to the presenters for a good introduction.
Good course and topic directly related to my work. THANKS!
Good overview. Would like to learn more about clinical trials.
Speakers delivered very detailed information in a cogent and understandable way.
Good grasp of the basics.
Very interesting course and knowledgeable instructors
very well done. covered the salient points!!
A very well done introduction and synopsis. Thank you very much.
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