Search Hyman, Phelps & McNamara PC's Attorneys

Michelle L. Butler provides counsel on government pricing, health care, and FDA law in the area of prescription drugs and biologics. Across these practice areas, she specializes in the interpretation of complex regulations. Ms. Butler advises clients on changes in health care law and how these changes affect calculation and reporting across government pricing programs, specifically the Medicaid Drug Rebate Program, the 340B Program, the Medicare Part B Average Sales Price calculation, and the...

Ricardo Carvajal works with manufacturers and marketers of food and dietary supplements, OTC drugs, and cosmetics on a range of FDA, USDA, and FTC regulatory issues. Mr. Carvajal advises clients ranging from start-ups to multinational companies at all points in the supply chain, including bulk ingredient manufacturers, distributors of packaged goods, and retailers. He counsels clients on the regulatory status of ingredients and finished products, and provides advice on compliance with labelin...

Robert A. Dormer is one of three founding members of Hyman, Phelps & McNamara, P.C. He has been an integral part of the firm’s growth and expansion in all areas of FDA law. He advises clients on a wide range of issues throughout the product lifecycle including development and approval, compliance, and enforcement. From 1976 to 1979, Mr. Dormer served in FDA’s Office of Chief Counsel. He was an Associate Chief Counsel for Enforcement and Associate Chief Counsel for Radiological...

Douglas B. Farquhar has more than 30 years of experience as a prosecutor and defense and regulatory attorney. Since joining the firm in 1997, he has advised pharmaceutical and medical device manufacturers and wholesalers, compounding pharmacies, and individuals on a wide range of enforcement activities, including consent decrees, criminal investigations, debarment issues, arbitration proceedings, civil seizures, FDA inspection issues, and injunctions. Mr. Farquhar has a broad-based understand...

Jeffrey N. Gibbs joined Hyman, Phelps & McNamara in 1990. Over the course of his career, he has developed an extensive knowledge of FDA law, from product approvals to advertising and promotion, and enforcement actions. In recent years, Mr. Gibbs has focused primarily on advising medical device and IVD companies, as well as pharmacies. Based on his extensive experience working with the industry on FDA issues, and previously for FDA, he provides efficient and insightful guidance. He has wor...

Paul M. Hyman is a founding member of Hyman, Phelps & McNamara. Since opening the firm in 1980, he has led efforts to make it the premiere FDA law practice. He brings five decades of perspective to the regulatory priorities and policies of FDA and FTC. Mr. Hyman has advised clients on nearly every aspect of FDA regulation, ranging from premarket approvals, to labeling and post-market compliance, and has defended against enforcement actions such as warning letters, recalls, and court actio...

Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage. She also has significant experience advising clinical laboratories on FDA and CLIA requirements for laboratory developed tests. Ms. Javitt’s experience prior to joining Hyman, Phelps & McNa...

Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity. As the co-founder and primary author of Hyman, Phelps & McNamara's FDA Law Blog , Mr. Karst often leads the response to new rules and regulations, sharing his interp...

Sara W. Koblitz advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, and the Orange Book. She helps drug and device manufacturers in various stages of product development and guides clients through the applicable regulatory requirements with respect to applications and submissions, device classification, potential exclusivities, promotional issues, and post-marketing requirements. Ms. Koblitz also counsels cosmetics, f...

Dara Levy helps pharmaceutical and medical device companies on a wide range of issues relating to product communications, marketing, and import/export. Dara assists clients with products in all stages of development to design engaging communications compliant with FDA legal and regulatory requirements. In the pre-marketing stage, Dara works with companies to strategically communicate with investors, potential marketing partners, and the scientific community, as well as implement effective dis...

Allyson Mullen provides counsel to medical device and in vitro diagnostic (IVD) manufacturers. Ms. Mullen assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters. In the premarket area, Ms. Mullen develops regulatory strategy, including obtaining breakthrough device designa...

Josephine Torrente’s practice focuses on bringing promising new drug and biological therapies through the FDA approval process. With more than 30 years of experience in the industry, Josephine provides essential regulatory insight and strategic perspective into the pursuit of aggressive objectives. Josephine advises biotech and pharmaceutical senior executives and development teams on strategic direction at critical moments in drug development, from preclinical and Phase 1 matters to co...

With more than 23 years of experience working with the pharmaceutical and medical device industries, Ms. Walsh brings FDA regulatory expertise to clients seeking to achieve their business objectives. She regularly counsels clients facing FDA administrative actions like inspections, warning letters, and recalls. But her passion is helping companies prevent or respond to government investigations, and she conducts internal investigations to achieve compliance and to best position her clients to...

Kalie E. Richardson focuses her practice on state and federal regulatory strategy and compliance, primarily for pharmaceutical manufacturers and wholesale distributors. She advises manufacturers, wholesale distributors, and pharmacies on state licensing strategy in all 50 states, the District of Columbia, and Puerto Rico. In 2019, Ms. Richardson was seconded to a client to assist with state licensing and disciplinary actions for over 400 state licenses. She has recently represented clients in...

James Valentine assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine also works with clients on clinical trials operations and compliance matters. Before joining the firm in 2014, Mr. Valentine worked in FDA’s Office of Health and Constituent Affairs (previously Office of Special Health Issues) where he facilitated patient input in benefit-risk deci...

Sarah L. Wicks counsels innovative drug and biologics companies on FDA regulatory and compliance matters that arise in the development and commercialization of new products and indications. These issues regularly include those relating to human subject protections and the conduct of clinical trials, product development strategies, interactions with the FDA, advertising, promotion and labeling, internal investigations and responding to FDA inspection observations and enforcement actions. Ms. W...