The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety,tobacco products,caffeine products,dietary supplements,prescription and over-the-counter pharmaceutical drugs (medications),vaccines,biopharmaceuticals,blood transfusions,medical devices,electromagnetic radiation emitting devices (ERED),cosmetics,animal foods &feed and veterinary products.
Prescription drug list prices in the United States continually are among the highest in the world. The high cost of prescription drugs became a major topic of discussion in the 21st century,leading up to the American health care reform debate of 2009,and received renewed attention in 2015. One major reason for high prescription drug prices in the United States relative to other countries is the inability of government-granted monopolies in the American health care sector to use their bargaining power to negotiate lower prices,and the American payer ends up subsidizing the world's R&D spending on drugs.
Frank Edward Young was an American physician who served as Commissioner of Food and Drugs from 1984 to 1989 and later as a deputy assistant secretary in the United States Department of Health and Human Services. In 2013 he joined Braeburn Pharmaceuticals as executive vice president,clinical and regulatory affairs. In 2018,he became the executive vice president of clinical and regulatory affairs at TissueTech Inc.
Adalimumab,sold under the brand name Humira and others,is a disease-modifying antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis,juvenile idiopathic arthritis,psoriatic arthritis,ankylosing spondylitis,Crohn's disease,ulcerative colitis,plaque psoriasis,hidradenitis suppurativa,and uveitis. It is administered by subcutaneous injection. It works by inactivating tumor necrosis factor-alpha (TNFα).
Rivaroxaban,sold under the brand name Xarelto among others,is an anticoagulant medication used to treat and prevent blood clots. Specifically it is used to treat deep vein thrombosis and pulmonary emboli and prevent blood clots in atrial fibrillation and following hip or knee surgery. It is taken by mouth.
The Duke University School of Medicine,commonly known as Duke Med,is the medical school of Duke University. It was established in 1925 by James B. Duke.
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted,with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees,the FDA is required to meet certain performance benchmarks,primarily related to the speed of certain activities within the NDA review process.
Stephen Michael Hahn is an American physician who served as the commissioner of food and drugs from 2019 to 2021. Before becoming commissioner,he was an oncologist serving as chief medical executive of the MD Anderson Cancer Center. In 2021,he became chief medical officer at Flagship Pioneering,the venture capital firm that launched Moderna.
The United States commissioner of food and drugs is the head of the Food and Drug Administration (FDA),an agency of the United States Department of Health and Human Services. The commissioner is appointed by the president of the United States and must be confirmed by the Senate. The commissioner reports to the secretary of health and human services.
Margaret Ann "Peggy" Hamburg is an American physician and public health administrator,who is serving as the chair of the board of the American Association for the Advancement of Science (AAAS) and co-chair of the InterAcademy Partnership (IAP). She served as the 21st Commissioner of the U.S. Food and Drug Administration from May 2009 to April 2015.
Brett P. Giroir is an American pediatrician. He was formerly the U.S. assistant secretary for health,a four-star admiral in the U.S. Public Health Service Commissioned Corps and an acting Food and Drug Administration commissioner.
Luciana Borio is a Brazilian-American infectious disease physician and public health administrator. She is a vice president at In-Q-Tel. She previously served as director for Medical and Biodefense Preparedness at the National Security Council,acting chief scientist of the U.S. Food and Drug Administration (FDA),assistant commissioner for counterterrorism policy of the FDA,and director of FDA's Office of Counterterrorism and Emerging Threats. She is known for her work advancing clinical trials,the development of medical countermeasures for health emergencies,and the public health responses to Ebola and Zika outbreaks.
Stephen Ostroff is an American physician. He served as acting commissioner of the U.S. Food and Drug Administration from April 1,2015,to February 21,2016,and from January to May 2017.
Scott Gottlieb is an American physician,investor,and author who served as the 23rd commissioner of the Food and Drug Administration (FDA) from May 2017 until April 2019. He is presently a senior fellow at the conservative think tank the American Enterprise Institute (AEI),a partner at the venture capital firm New Enterprise Associates (NEA),a member of the board of directors of drug maker Pfizer,Inc and gene sequencing company Illumina,Inc. and a contributor to cable financial news network CNBC and the CBS News program Face the Nation. An elected member of the National Academy of Medicine,Gottlieb is the author of The New York Times best selling book Uncontrolled Spread on the COVID-19 pandemic and the national security vulnerabilities that it revealed. His forthcoming book,The Miracle Century:Making Sense of the Cell Therapy Revolution,traces the scientific achievements that propelled progress in cell therapies.
The 21st Century Cures Act is a United States law enacted by the 114th United States Congress in December 2016 and then signed into law on December 13,2016. It authorized $6.3 billion in funding,mostly for the National Institutes of Health. The act was supported especially by large pharmaceutical manufacturers and was opposed especially by some consumer organizations.
Janet Woodcock is an American physician who served as Principal Deputy Commissioner of Food and Drugs from February 2022 until February 2024,having previously served as Acting Commissioner of the U.S. Food and Drug Administration (FDA). She joined the FDA in 1986,and has held a number of senior leadership positions there,including terms as the Director of Center for Drug Evaluation and Research (CDER) from 1994 to 2004 and 2007 to 2021.
Rimegepant,sold under the brand name Nurtec ODT among others,is a medication used for the acute treatment of migraine with or without aura in adults and the prophylactic/ preventive treatment of episodic migraine in adults. It is taken by mouth to dissolve on or under the tongue. It works by blocking CGRP receptors.
Jeffrey Leiden is an American physician,scientist and businessman who is the executive chairman of Vertex Pharmaceuticals,a biotechnology company based in Boston,Massachusetts. He was initially appointed to the board of directors of the company in 2009 and was CEO and president from February 2012 to March 2020.
Hilary D. Marston is the Chief Medical Officer of the Food and Drug Administration.
