Risky Business


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The pharmaceutical industry faces more inherent risks and higher stakes than almost any other industry because its products impact patient safety and well-being.
Intensified public and media scrutiny about medication errors and drugs being pulled off the market have industry executives, with guidance from the FDA, working to assess the risks and develop programs to ensure the safety of all processes.
Risk permeates almost every area and discipline within the pharmaceutical industry. So the scope and opportunities for risk-management programs are vast. While companies have always worked to ensure the safety of their products, regulatory authorities around the globe are requiring more formalized strategies to minimize safety risks throughout the product life cycle.
Recent guidances from the Food and Drug Administration have outlined activities around the general topic of risk management. These include the 2002 Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach and the more recent guidances that focus around the narrower topic of product-specific risk management (pharmacovigilance) as directed by the Prescription Drug User Fee Act III (PDUFA-III)…

Selected Risk-Management Programs
Sound Bites From the Field
The FDA’s Risk-Based Initiatives

Experts on this Topic
Gerald Faich, M.D., MPH. Chief Medical Officer, BBCI, a UBC company, Kansas City, Mo.; BBCI is an international provider of Phase II-IV clinical development services to the pharmaceutical, biotech, generic, and drug-delivery industries. Dr. Faich was formerly head of the Office of Epidemiology and Biostatistics at the FDA. For more information, visit
Jeffrey E. Fetterman. President and CEO, ParagonRx, Wilmington, Del.; ParagonRx supports the commercialization and growth of pharmaceutical brands by improving the process by which clinicians use them; this process is the key element of effective medical-education and risk minimization-action plans (RiskMAPs). Mr. Fetterman also is coauthor of “A Framework For Pharmaceutical Risk Management.” For more information, visit
Theodore W. Frank. CEO, Axentis Inc., Warrensville Heights, Ohio; Axentis is a leading provider of governance, risk, and compliance management software. For more information, visit
Gene Guselli. Cofounder, President, and CEO, InfoMedics Inc., Woburn, Mass.; InfoMedics develops and implements large-scale risk-management systems that communicate the facts about a medication’s risks while preserving itsbenefits; through technologies that optimize safe use of a medication both before and after it is in the patient’s hands, manufacturers are able to deliver targeted educational and behavioral interventions, employ distribution controls and systematically measure the impact of risk- management efforts. For more information, visit
Sam Holtzman, Ph.D. Chairman, President, and CEO, Rosa Pharmaceuticals Inc., Cupertino, Calif.; Rosa Pharmaceuticals develops drugs through their critical and highly uncertain proof-of-concept stage; Rosa Consulting is a division of Rosa Pharmaceuticals that provides strategic risk-management and drug-development services to pharmaceutical and biotechnology firms. For more information, visit
David E. Lilienfeld, M.D. Senior Director of Drug Safety, InterMune, Brisbane, Calif.; InterMune is a biopharmaceutical company focused on the applied research, development, and marketing of life-saving therapies for pulmonary and hepatic diseases. For more information, visit
Louis A. Morris, Ph.D. President, Louis A. Morris & Associates Inc., Dix Hills, N.Y.; Louis A. Morris specializes in regulatory research and consulting. Dr. Morris spent 23 years at the FDA and is a member of the FDA’s Drug Safety and Risk Management Advisory Committee. For more information, e-mail
Leyna Mulholland, Ph.D. Senior Manager, Pharmaceutical Development, Merck & Co., Whitehouse Station, N.J.; Merck is a global research-driven pharmaceutical products company. For more information, visit
Frances E. Nolan. VP, Consultant, Taratec, Bridgewater, N.J.; Taratec provides regulatory guidance and solutions for the business and information technology challenges unique to the life-sciences industry. For more information, visit
Matthew Reynolds, Ph.D. Senior Director, Risk Management and Safety, MetaWorks Inc., Medford, Mass.; MetaWorks is a healthcare consulting company focused on clinical drug development and commercialization within the pharmaceutical, biotechnology, and healthcare industries. For more information, visit
Linda Sadler. Executive VP, Managing Director, Adient, Wayne, N.J.; Adient, a CommonHealth company, is a leader in the next generation of full-service healthcare-communications firms. For more information, visit