An Insider's Perspective to Navigating FDA, and an Outside Counsel’s Role to Navigating FTC.
More than 70 years ago, the Food, Drug and Cosmetic Law Section became one of the first sections to be formally organized by the New York State Bar Association. During the ensuing years, this group – the first organization in the country to be composed of in-house, law firm, government and trade association attorneys practicing food and drug law – has been a focal point for practitioners in this specialty. We welcome you to our expanded website!
Meet the Chair
Brian J. Malkin of Washington, D.C. is the new chair of the Food, Drug and Cosmetic Law Section.
Malkin is counsel to Arent Fox LLP. He has more than 23 years of food and drug law practice and over 12 years of intellectual property law practice. In particular, his practice includes the interrelation between patent law and food and drug law. Brian’s regulatory experience includes all types of FDA-regulated products: drugs and biologics (including animal drugs and biologics), medical devices, foods and dietary supplements, tobacco products, and cosmetics. His intellectual property experience includes FDA and patent litigation for both innovator and generic companies, as well as patent prosecution for life science companies.
A 12-year member of the State Bar, Malkin also is a member of the Health Law, Intellectual Property Law and International Sections.
Malkin earned his undergraduate and law degrees from George Washington University. He also has a Bachelor of Science degree in biochemistry from the University of Maryland.
Contact the Food, Drug & Cosmetic Law Section LiaisonTo learn more about this Section, please contact Lisa Bataille
Legal and Regulatory Legislative Memoranda
- Comments re FDAs Guidance Entitled “Nonproprietary Naming of Biological Products – May 2019
- Comments re FDA’s Definition of the term “Biological Product” – February 25, 2019
- Comments re FDA’s Facilitating Competition and Innovation in the Biological Products Marketplace – September 21, 2018
- Deemed to Be a License Provision of the Biologics Price Competition– May 13, 2016
- Comments on U.S. FDA Guidance entitled “Framework for Regulatory Oversight of Laboratory Developed Tests” – January 28, 2015
- Comments on FDA Draft Guidance No. 230– “Guidance of Industry Compounding Animal Drugs from Bulk Drug Substances,” August 17, 2015
- Comments on “Non Proprietary Naming of Biological Products:Guidance for Industry,” October 26, 2015
Food, Drug & Cosmetic Law Section Committee
- FDA’s Electronic Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)
- [email protected]
- Biologics Products and Establishments
- Recently-Approved Devices
- Animal [email protected]
- FDA inspections, Compliance, Enforcement and Criminal Investigations
- FDA Docket Notice (www.regulations.gov)
- Purple Book (approved human biologics)
- Green Book (approved animal drugs)
- Medical Device Approvals (PMAs)
- Medical Device 510(k)s
International Regulatory Authorities
- European Medicines Agency
- European Union Clinical Trials Register
- Medicines and Health Care Products Regulatory Agency (United Kingdom)
- Health Canada
- Pharmaceuticals and Medical Devices Agency, Japan
The New York State Bar Association (NYSBA) established the Food, Drug and Cosmetic Law Section in 1945 as one of the first sections of the NYSBA.
The Food, Drug and Cosmetic Law Section was formed in 1945 following enactment of the Food, Drug and Cosmetic Act of 1938 (“the Act”). This NYSBA section was the first of its kind in the nation, serving as the forum for those experts in this field in the private and public sectors. The Chair cited the importance of the increasing the bar’s knowledge of the Act, the work of the Food and Drug Administration, the intended consumer benefits, and the enhancement of technical and ethical standards of industries involved.
“The action of the Association, setting up a Section on Food, Drug and Cosmetic Law, is worthy of special notice not only as this is the first Section of its kind, but also because it will tend to give this branch of law the prestige, the dignity, and the attention which it so clearly merits.” – Charles Wesley Dunn, first Chair, on the creation of the Section.
In addition to food, drug, and cosmetic issues, committees were also created on related fields of practice. Within several years of creation, the Section successfully urged creation of a Food and Drug Committee within the Administrative Law Section of the American Bar Association. Over the years, the Food, Drug and Cosmetic Law Section’s committees have evolved to meet the times.
In its first year, the Section began professional education programs continued today on legislative and administrative developments, ramifications of amendments to the Act, enforcement procedures, approval and marketing in interstate commerce, advertising compliance, and product liability issues. The focal point for the Section’s professional education has always remained the NYSBA’s Annual Meeting, supplemented with specialty topics and events throughout the year.