Scott Gottlieb, head of FDA, submits his resignation!

On March 5, 2019, Scott Gottlieb, head of the U.S Food and Drug Administration (FDA), resigned, arteria.com learned According to the Washington Post, the first to report, Gottlieb will leave regulators in about a month Gottlieb wants to spend more time with his family, the Post said Gottlieb, 46, is the father of three, a pair of nine year old twins and a five-year-old He needs to commute to Connecticut every week Since taking office in May 2017, Gottlieb has actively supported the approval of new brand drugs and generic drugs In addition, he has focused on a number of public health issues, including the Opium epidemic and smoking that have swept the country According to the Washington Post, Gottlieb's resignation surprised the White House He was favored by the trump administration and hired for his positive attitude towards reshaping federal regulators Alex Azar, Minister of health and human services, said he was proud of Gottlieb's work during his two years as head of FDA Azar says he is an active advocate of American patients and an enthusiastic promoter of innovation In a statement, Azar said Gottlieb's leadership has brought about historic results and provided "record approval for innovative therapies and generic drugs with peaceful prices." Since taking over the U.S Food and drug administration, Gottlieb has been using his twitter account to inform the public about various initiatives he has taken and to keep the public informed during the FDA closure earlier this year Last month, Gottlieb developed a new FDA plan to address the opiate crisis Gottlieb said the FDA has changed its attitude towards the opioid crisis and will take a more positive attitude towards regulatory action In his statement, Gottlieb noted that the FDA's wait for "established evidence of injury accumulation" has led to a crisis of trust in FDA communities across the country, although at times the crisis is not obvious Also in February, Gottlieb outlined new ways to accelerate the review of generic applications This approach demonstrates FDA's efforts to increase competition and reduce drug prices Gottlieb said the agency has been taking steps to support "downward pressure" on drug pricing, which means they want to influence increasing competition through more generic drugs Gottlieb said that there are many brands of drugs in the market that do not compete with generic drugs, which could keep prices high and "ultimately hurt American patients." FDA is working to reduce barriers to generic development and reduce the cost of generic access to the market in order to increase patient choice in disease treatment During his tenure, Gottlieb also supported the development of biosimilars for the U.S market and was cracking down on unapproved plasma anti-aging treatments Gottlieb had a long career in public health policy before he was recently head of the FDA From 2003 to 2004, Gottlieb was a senior consultant to the head of FDA, and later served as the agency's director of medical policy development In 2004, Gottlieb served as a senior consultant for Medicare and Medicaid services He then served as FDA's Deputy Commissioner for medical and scientific affairs from 2005 to 2007 In addition to his work in public health, Gottlieb has also served as a consultant for companies such as Novo Nordisk, GlaxoSmithKline and Daiichi Sankyo Prior to becoming head of FDA, Gottlieb worked as a risk partner in new enterprise associates and as a resident researcher at the American Enterprise Institute, a conservative think tank With Gottlieb resigning as commissioner, the question now turns to who will replace him Although it's too early to talk about it, some names that may have been appointed by the White House have emerged, including Jim O'Neill He has called for FDA reform, including the approval of drugs that have been proven safe but not yet proven effective.