Food, Drug & Device/FDA
Industry knowledge and government experience combine to form Alston & Bird’s cutting-edge food, drug and device practice. Whether advising clients on the proper screening of human tissue donors, regulatory strategies to confront impending generic Rx drug competition, premarket notification requirements for software-based medical devices, advantages to marketing products as medical foods or limitations on Rx drug advertising and promotion, our broad skill set enables quick, inventive and effective regulatory solutions for our clients. Our practice centers on products and product components that are regulated or affected by the provisions of the Federal Food, Drug, and Cosmetic Act and related laws, administered by the Food and Drug Administration (FDA) or other related entities, guiding clients through each phase of product development, marketing and distribution, from the invention stage through post-market surveillance activities. Additionally, the firm’s “bench-to-bedside” product development practice includes seamless collaboration between the regulatory FDA practice and drug and device pricing, reimbursement, coverage and coding; fraud, abuse and false claims; provider health care law and Stark self-referral provisions; legislative and public policy; intellectual property and licensing; corporate transactional; environmental; product liability litigation; import-export; federal and state taxation; antitrust; and other related product areas.
EXPERIENCE
The regulatory requirements for products regulated by the FDA are constantly evolving as the agency determines how it will regulate nanotechnology, biosimilars, tissue-based products, cloned foods and other innovative new products across the food, drug, medical device and cosmetic industries. Our team routinely advises clients on compliance with state and federal laws affecting FDA-regulated products. In addition, we help chart the “regulatory course of least resistance” by preparing and reviewing company responses to agency correspondence regarding, among other things, treatment investigational new drug applications, orphan and pediatric drug designations, 510(k) deficiency letters, promotional activities, establishment inspections and product recalls.
WHAT SETS US APART
Alston & Bird’s attorneys assist clients in the food, drug, device, cosmetic and supplement industries by developing creative and successful solutions to the regulatory challenges that they face. Our technical expertise and comprehensive understanding of the industry and regulatory bodies, in which our lawyers have actually served, coupled with our responsiveness, effectiveness and seamless access to experts in other legal areas affecting food, drug and device industry clients sets our team well ahead of the competition. Among the attorneys in the practice are a former FDA associate commissioner for legislative affairs and a former associate chief counsel for enforcement at the FDA, also having served as the associate chief counsel for medical devices.
RECOGNITION
Members of the Food, Drug and Device team have headed the American Bar Association’s Committee on Food and Drug Law, hold senior positions within the Food and Drug Law Institute, participate in the Drug Information Association, and provide in-house legal training for FDA officials, including reviewers. In addition, team members are viewed as thought leaders in the health care industry and serve as presenters in industry seminars and are quoted frequently in major news and industry publications.
FROM CONCEPT TO MARKET
Our clients span the product life timeline from inventors who have conceptualized a product idea and investors wishing to fund new products to manufacturers, distributors, retailers and end users across the food, drug and device industries. We also represent various trade associations, research institutions and health care providers.