Mr. Richman’s background, expertise and extensive knowledge of the U.S. Food and Drug Administration (FDA) permit clients to achieve compliance with drug GMP regulations, including assistance in interacting with FDA during compliance inspections, preparing comprehensive responses to FDA’s FD-483 observations, and in attending regulatory meetings with FDA. In his work, Mr. Richman reviews and advises firms on applicable ICH and FDA guidance documents and GMP regulations regarding quality systems, stability data, process validation, and laboratory controls. He routinely provides assistance on import-export issues.
During his career with the FDA, Mr. Richman held numerous senior-level enforcement and management positions dealing with assessing the compliance of pharmaceutical and medical device firms as well as firms in other FDA regulated industries, both domestic and foreign.
As an Investigator, he conducted numerous inspections of pharmaceutical and medical device manufacturers to determine their compliance with Good Manufacturing Practice (GMP) regulations, new drug/device pre-market approval and labeling requirements, and worked with FDA and U.S. Department of Justice attorneys in bringing successful enforcement actions against chronic violators.
As a field Compliance Officer, Mr. Richman prepared many regulatory action recommendations, including those for civil actions such as product seizure and injunctions as well as recommendations for criminal prosecutions and grand jury investigations. Mr. Richman prepared recommendations for criminal and administrative sanctions, including withdrawal of Abbreviated New Drug Applications (ANDAs), with regard to certain generic drug manufacturers in New York that were found to have submitted fraudulent data to the agency as part of their ANDA submissions. His work on a major FDA felony prosecution case earned him a Special Citation presented to him by the U.S. Attorney General in Washington, D.C.
Mr. Richman served as a Senior Case Review Officer in FDA’s Office of Enforcement, where he was responsible for reviewing and clearing for the Office of the Commissioner, legal action recommendations submitted by FDA field offices nationwide.
In 1996, Mr. Richman took on the position of Team Leader for the Adverse Drug Reaction and Pharmacy Compounding Team in FDA’s Center for Drug Evaluation and Research (CDER). Under his guidance, the team was instrumental in increasing the depth and number of FDA’s annual inspections of both domestic and foreign drug manufacturers to better assess their compliance with the agency’s critical adverse drug experience reporting requirements. His team was also engaged in the development of a pharmacy compounding law and related regulations to give the agency authority to properly regulate those companies manufacturing large quantities of commercially available drug products under the guise of pharmacy compounding.
In his subsequent position in CDER, as Deputy Director, Division of New Drugs and Labeling Compliance, Mr. Richman supervised regulatory operations relating to the compliance of prescription drugs, Over-the-Counter (OTC) drugs, import and export drug issues, and internet and health fraud issues. He was instrumental in developing and initiating an important regulatory strategy to address the marketing of unapproved drug products.
In 2005, Mr. Richman became the Director of the Division of Compliance Management and Operations (DCMO) in FDA’s Office of Enforcement. In that position, he assisted FDA’s field compliance offices in developing regulatory strategy to address violations documented during inspections. He conducted meetings with top corporate officials representing firms that were the subject of agency-issued warning letters and for whom legal actions were being considered to bring these firms into compliance with FDA laws and regulations.
Mr. Richman has made numerous presentations to groups such as the Regulatory Affairs Professionals Society (RAPS), the Drug Information Association (DIA), the Pharmaceutical Education Research Institute (PERI), and the Food and Drug Law Institute (FDLI) on diverse drug and device compliance issues. Most recently, he presented a webinar for PERI on “FDA Regulatory Actions: The Consequences of Non-Compliance” and gave a presentation on “Violations and Enforcement” at an FDLI seminar on drug regulation.
Mr. Richman was recently selected by the Food and Drug Law Institute (FDLI) to serve on its new Global Committee. This committee is charged with assisting FDLI staff in developing and delivering educational conferences and publications. He and the other committee members will provide input to staff on legal, regulatory, and policy activities and developments in food and drug law in countries of interest and suggest ways to further the strategic goals of FDLI’s global initiative.
Mr. Richman obtained a B.A. degree in Chemistry from Queens College of the City University of New York, Flushing, New York, and an M.S. degree in Chemistry from St. John’s University, Jamaica, New York. He resides in Gaithersburg, Maryland.