Food and Drug Law
Nearly 25% of all consumer spending in the United States involves products manufactured by industries regulated by the Food and Drug Administration (FDA). These include manufacturers and vendors of human and veterinary drugs, medical devices, vaccines and other biological products, food products (including certain restaurants), cosmetics, dietary supplements, and tobacco products. If your business touches upon these areas, it is likely you are in some manner subject to regulatory oversight and potential enforcement actions that run the gamut from winning pre-approval to sell your product; to limits on what you can say about what your product can do; to surprise inspections of your facilities; and to seizure and embargo of your product inventory.
Our food and drug law practice offers the experience of professionals with backgrounds in science, intellectual property and marketing, particularly matters covered by the Food, Drug and Cosmetic Act (FDCA) and the Federal Trade Commission Act (FTCA). Our ability to defend companies and individuals who have come under FDA or FTC scrutiny grows out of our prior experiences investigating and prosecuting such matters on behalf of the U.S. Department of Justice. We can represent targets, subjects and witnesses of investigations. Earlier in the enforcement process, if your plant has been subject to a surprise inspection, we can help you respond to the investigation, or to organize your response to any “Form 483” report or other evaluation the FDA issues. We can also work with you in non-crisis situations so you can be better prepared for and ready to respond to such governmental oversight of your daily operations. And, if criminal or civil charges are brought against you, we can defend them. In addition to investigations turning on questions of product (e.g, “off-label”) marketing and FTC regulations governing false advertising and misrepresentation, we have experience dealing with matters involving current Good Manufacturing Practices (cGMP), health care fraud, fraud in the product approval process, false claims, HIPAA privacy and compliance issues (e.g., pertaining to the HiTech Act), and Stark anti-kickback charges.