The U.S Food and Drug Administration (FDA) plays a critical role in protecting and promoting the health of all Americans. Every day, the FDA does important work to ensure the safety, efficacy and security of our nation’s medical products, including human drugs and biologics. From reviewing the drug profile of a first-in-class medicine up for approval, to inspecting a medicine’s manufacturing site, the FDA’s experts engage in a range of regulatory review activities intended to bring safe and effective new medicines to patients in a timely manner. In the past year alone, the FDA approved a record number of new medicines to fight a range of diseases, including multiple sclerosis, Alzheimer’s disease and Parkinson’s disease.
The FDA is also on the front lines helping to deliver increased personalized medicine access to patients. The agency’s efforts approving new immunotherapy and cell and gene-based therapy treatment options, which harness a patient’s own immune system to defeat a disease, are revolutionizing the treatment paradigm. At the same time, the agency is enhancing a competitive biopharmaceutical marketplace, including approving a record-setting number of generic medicines in 2017.
None of these milestones would have been possible without the dedicated professionals who work at FDA and contribute to the agency being recognized as the gold-standard for the regulatory review of drugs and biologics. I should know: during my time at the FDA as the Deputy Center Director for Science Operations for the Center for Drug Evaluation and Research, I had the privilege of working with these talented professionals who bring to bear their expertise and hard work to fulfill the FDA’s public health oversight mission and ensure the medicines we take are safe and effective for ourselves and our loved ones.
A stable and sustainable workforce is crucial to the FDA’s success in keeping pace with scientific advances in biopharmaceutical drug development and ensuring safe and effective innovative medicines reach patients in a timely manner. However, the FDA has faced significant human resource challenges in recent years, requiring that the agency and the biopharmaceutical industry work together to find solutions to enhance its recruiting and hiring.
Under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI), the second authorization of the Biosimilar User Fee Act (BsUFA II), and through passage of the 21st Century Cures Act, the FDA has been given additional resources and new hiring and pay authorities to build and maintain the agency’s workforce. These include agency hiring goals and related recruitment and retention initiatives, a hiring pilot intended to modernize and streamline hiring processes, and establishment of a dedicated staffing team charged with the continuous recruiting, staffing, and retention of scientific, technical and professional staff – the biostatisticians, medical reviewers, and project managers, just to name a few - who want to make a difference in the lives of Americans.
America’s biopharmaceutical companies are taking bold steps to develop medicines to treat life-threatening diseases and give hope to patients, providers and caregivers alike, as well as bring value to the health care system. But we can’t do it alone. As we embark on this new era of medicine, the FDA must continue to grow its team of dedicated professionals ready to tackle some of the most complex medical issues of our time. If you are interested in serving, please visit the agency’s hiring page.
Richard Moscicki, M.D. Dr. Moscicki came to PhRMA in 2017 after serving as the Deputy Center Director for Science Operations for the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) since 2013. While at FDA, Dr. Moscicki brought executive direction of Center operations and leadership in overseeing the development, implementation, and direction of CDER’s programs. Previous positions include serving as Chief Medical Officer at Genzyme Corporation from 1992 to 2011, where he was responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He served as the senior vice president and head of Clinical Development at Sanofi-Genzyme from 2011-2013.