Food, Drug and Medical Device Regulatory
Sidley's Food, Drug and Medical Device Regulatory practice is highly ranked by
Chambers USA,
Chambers Global and
PLC Life Sciences Handbook and well recognized among leading companies in those industries.
“Sidley Austin is recognized as a leading firm for FDA regulatory work … ”
Sources say “"They are extremely knowledgeable and they can always execute any plan we put together.."
Chambers USA
, 2011
Our Clients
We represent major pharmaceutical, biotechnology, medical device, food (including dietary supplement), tobacco product and cosmetics companies in the U.S., EU and Asia. Our client base is diverse, but united by a common thread: a commitment to engagement with product regulatory agencies that is both creative and pragmatic. We tackle the hardest regulatory problems by offering our clients solutions that account for not only direct risk but also the substantial relational capital at stake and the complex business realities that our clients face. Our portfolio is heavily weighted toward fully integrated, multinational, innovator pharmaceutical, biotechnology and medical device manufacturers, and we take a particular interest in development stage companies confronting regulatory issues for the first time.
“The lawyers have dual expertise in general healthcare and FDA regulatory work and the team’s prowess in investigations is highly prized.”
Sources say “"An excellent, well-rounded practice with great industry expertise."
Chambers USA, 2010
Our Approach
We confront our clients' most challenging regulatory issues by creating innovative, practical solutions that account for complicated business realities. We encourage a portfolio approach to risk management, involving careful discrimination among the many areas of regulatory ambiguity our clients face across specific franchises and the entire enterprise.
We remain attuned to changes in the regulatory environment driven by government agencies and media attention. Our lawyers assist clients in responding to FDA's expanding statutory authority, its greater attention to enforcement and the slowdown in product approvals by providing pivotal legal and regulatory arguments and strategic advice. At the same time, we are acutely aware of the differences between matters in which lawyers properly occupy a central role and those more appropriately handled primarily by scientists and regulatory affairs personnel. We discourage any over-involvement of legal professionals that would be contrary to our clients’ best interests.
Our Service
From clinical trials and marketing authorizations to post market safety, our lawyers help clients with the full range of regulatory issues they confront at every stage of the product life cycle. We assist clients on strategies and government interactions relating to:
- Marketing Authorization Strategies;
- Clinical Trial Development;
- Promotional Practices;
- Post-Marketing Safety Plans;
- Product Classifications; and
- Multi-Continent Regulatory Initiatives.
We also focus on products and technologies that are subject to rapidly evolving and complex regulatory requirements, including new in vitro diagnostic devices, combination products and software.
For consumer products companies, we combine substantial experience with both regulatory and enforcement matters relating to FDA, FTC, Lanham Act, and state consumer fraud law requirements. Our labeling, monograph and substantiation reviews, defense of investigations and product launch advice combine these interdisciplinary concerns.
In the food arena, our team helps navigate regulatory pathways for medical foods, foods for special dietary use, conventional foods, dairy products and dietary supplements, and has represented both major finished product and ingredient suppliers on a number of regulatory issues on three continents. Safety determinations for dietary supplements and foods are becoming an increasing part of our team's work.
Another major focus of our practice involves regulatory due diligence in connection with transactions. Our lawyers assist equity investors, lenders and acquiring companies in evaluating opportunities in all life sciences sectors and assist clients in conducting regulatory due diligence, thereby enabling them to make comprehensive risk assessments.
Further, our practice focuses on issues arising under the Hatch-Waxman Act, such as market exclusivity periods, patent listing and certification requirements, 505(b)(2) issues and bioequivalence standards. In addition to Hatch-Waxman exclusivity, we also focus on obtaining and protecting market exclusivity related to orphan drugs and pediatric studies. Our FDA regulatory lawyers work closely with our patent and antitrust lawyers to provide an integrated approach to important life cycle management issues.
Our Team
A number of our lawyers have worked at the FDA, USDA, FTC and the European Medicines Agency in various senior positions. Our group includes a former Acting FDA Chief Counsel, a former Special Assistant to the FDA Chief Counsel, former federal prosecutors—including one who was in charge of FDA’s special prosecution task force—and a former member of the European Commission’s Legal Service with responsibility for review of all food and drug related proposals. Our group also has a U.S.-qualified physician, an EU physician, a bioethicist and a Ph.D. geneticist.
Coleen Klasmeier has "tremendous knowledge of FDA rules, regulations and contacts." Satisfied clients report: "She gives pragmatic advice, and is always attentive to our business needs."
Chambers USA, 2011
“Scott Bass is acknowledged across the country for his FDA enforcement and regulatory expertise.”
Chambers USA, 2011
Achievements
- Sidley received first-tier national rankings in FDA Law and Biotechnology Law, as well as first-tier rankings in Chicago and Washington D.C. in both practice areas in the U.S.News – Best Lawyers “Best Law Firms” rankings for 2011/12, and the most first-tier national rankings of any U.S. law firm overall for the second straight year.
- Sidley received a first-tier national ranking for Biotechnology Law, first-tier rankings in FDA Law and Biotechnology Law in Washington D.C. in the inaugural U.S.News - Best Lawyers “Best Law Firms” survey for 2010, published by U.S.News & World Report, and the most first-tier national rankings of any U.S. law firm overall.
- Sidley’s regulatory practice in the U.S., EU and China has been recognized by Practical Law Company (PLC) continuously in its Cross-border Life Sciences Handbook since 2007. Scott Bass, Coleen Klasmeier, Yang Chen and Maurits Lugard are ranked as leading lawyers in the field.
- Since 2008, Sidley has received Global Life Sciences Rankings from Chambers Global, National Life Sciences rankings from Chambers USA, as well as national and state rankings in two specific life sciences regulatory disciplines: Life Sciences: Regulatory and Compliance and Healthcare: Pharmaceutical/Medical Products Regulatory. Sidley lawyers Scott Bass and Coleen Klasmeier are listed as leaders in these fields.
- BTI Consulting Group, Inc., an independent research firm, named Sidley as the single “Pharmaceuticals Most Recommended Law Firm” and the single “Pharmaceuticals Leading Short Lister” in its 2008 Industry Power Rankings based on its interviews with industry insiders.
- Sidley has been named as the number one law firm in the United States for Life Sciences in The International Who’s Who of Life Sciences Lawyers, published by Who’s Who Legal in February 2010. Eight partners from Sidley’s Chicago, Los Angeles, New York and Washington, D.C. offices are recognized as leaders in the field, a figure unmatched by any other firm in the guide.
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