Keller and Heckman’s global Food and Drug practice counsels clients on all aspects of pharmaceutical requirements and compliance issues, including current good manufacturing practice requirements, labeling and advertising issues, conducting product recalls, U.S. Food and Drug Administration (FDA) inspection practices, and defending against government enforcement actions and competitor challenges in court and other forums. 

Regulatory Requirements and Strategies

Keller and Heckman attorneys have significant experience in a variety of drug regulatory matters, including opportunities to influence FDA policy development through the rulemaking, guidance, and citizen petition processes. This includes extensive dealings with FDA’s expedited programs for drugs intended to treat serious or life-threatening diseases and conditions, such as accelerated approval. We have a detailed understanding of FDA’s authority to withdraw approval of drug products; the drug establishment registration and listing requirements; FDA’s post-approval drug safety authorities; the regulation of drug/device combination products; the jurisdictional boundary between drugs and devices; drug labeling, including inactive ingredient listing; and FDA’s safety evaluation of inactive ingredients.  

We advise clients on the regulatory requirements for marketing authorizations for medicinal products and investigational new drug applications (INDs) and assist in submitting applications for these products. In addition, Keller and Heckman attorneys help conduct research to support applications for regulatory approval, new drug applications (NDAs) for initial approval of drug products, and abbreviated new drug applications (ANDAs) for approval of “generic” drugs.

We analyze the complex legal and policy issues regarding the Hatch-Waxman Act and the patent certification implications for ANDAs and Section 505(b)(2) NDAs, as well as help evaluate the potential impacts of the Prescription Drug User Fee Act and the Prescription Drug Marketing Act. On behalf of clients, Keller and Heckman attorneys develop regulatory strategies for the commercialization of new drugs and advise clients on the impacts of different non-patent market exclusivity periods.

Compliance Issues

Keller and Heckman attorneys assist clients in determining the status of over-the-counter (OTC) drugs and their compliance with applicable monographs, and ensure compliance with import and export regulatory requirements. In addition, we help clients evaluate compliance with national pharmacopeial monographs and prepare and file Drug Master Files for active ingredients, inactive ingredients, and packaging components. 

Representative Matters

• Worked with companies to develop acceptable formulations and labeling for OTC drug products in various categories, including topical antiseptics (hand sanitizers); antiacne; cough/cold remedies; sunscreens; external and internal analgesics (pain relievers); antidandruff shampoos; and oral healthcare products (fluoride, antiplaque/antigingivitic) 
• Provided expert witness testimony in Lanham Act litigation between two drug companies regarding FDA’s policies and procedures