Frank Edward Young (physician)
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Frank Edward Young (September 1, 1931 – November 24, 2019) was an American physician who served as
Commissioner of Food and Drugs 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 an ...
from 1984 to 1989 and later as a deputy assistant secretary in the
United States Department of Health and Human Services The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the US federal government created to protect the health of the US people and providing essential human services. Its motto is ...
. 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.


Education

Young received an M.D. degree (cum laude) from the State University of New York Upstate Medical Center in Syracuse in 1956 and a Ph.D. in microbiology from
Western Reserve University Western may refer to: Places *Western, Nebraska, a village in the US * Western, New York, a town in the US * Western Creek, Tasmania, a locality in Australia * Western Junction, Tasmania, a locality in Australia *Western world, countries that ...
in Cleveland, Ohio, in 1962.


Medical career

Young completed his residency in
pathology Pathology is the study of disease. The word ''pathology'' also refers to the study of disease in general, incorporating a wide range of biology research fields and medical practices. However, when used in the context of modern medical treatme ...
at the University Hospitals, Western Reserve University. He went on to become chairman of the Department of Microbiology and professor of microbiology, pathology and radiation biology and biophysics at the
University of Rochester The University of Rochester is a private university, private research university in Rochester, New York, United States. It was founded in 1850 and moved into its current campus, next to the Genesee River in 1930. With approximately 30,000 full ...
. Before his appointment as Commissioner of the Food and Drug Administration, he was dean of the School of Medicine and Dentistry and vice president for health affairs at the University of Rochester.


Tenure as FDA Commissioner

Young was sworn in as Commissioner of the Food and Drug Administration by Secretary of Health and Human Services
Margaret Heckler Margaret Mary Heckler (née O'Shaughnessy; June 21, 1931 – August 6, 2018) was an American politician and diplomat who represented in the United States House of Representatives from 1967 until 1983. A member of the Republican Party, she al ...
on August 2, 1984. During his tenure, Young presided over several major agency events, including the
Drug Price Competition and Patent Term Restoration Act The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States. ...
(1984), passage of the
Prescription Drug Marketing Act {{Regulation of therapeutic goods in the United States The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government. It establishes legal safeguards for prescription drug distr ...
(1987), approval of the first drug to combat
AIDS The HIV, human immunodeficiency virus (HIV) is a retrovirus that attacks the immune system. Without treatment, it can lead to a spectrum of conditions including acquired immunodeficiency syndrome (AIDS). It is a Preventive healthcare, pr ...
,
zidovudine Zidovudine (ZDV), also known as azidothymidine (AZT), was the first antiretroviral medication used to prevent and treat HIV/AIDS. It is generally recommended for use in combination with other antiretrovirals. It may be used to prevent mothe ...
(AZT) (1987), development of the treatment use of Investigational New Drugs (IND) for the desperately ill, such as people with AIDS, cancer and heart disease (1988); managing the generic drug crisis (1989), during which three officials of the Food and Drug Administration pleaded guilty to receiving bribes, and two manufacturers of generic drugs admitted to providing false data, and the
1989 Chilean grape scare The Chilean grape scare was a 1989 incident involving two grapes from Chile allegedly found tainted with cyanide after a threat was supposedly made by phone to the US embassy in Santiago. No additional contaminated fruit was found, but the Unite ...
, where Chilean grapes were temporarily banned by the FDA because of a threat and the discovery of two cyanide-tainted grapes.


After the FDA

Young left the FDA in 1989 to become Deputy Assistant Secretary for Health, Science, and Environment under Health and Human Services Secretary
Louis Wade Sullivan Louis Wade Sullivan (born November 3, 1933) is an American physician, author and educator who served as the Secretary of the United States Department of Health and Human Services during President George H. W. Bush's Administration and was Found ...
. Subsequently, Young served as director of both the Office of Emergency Preparedness and the National Disaster Medical System during the Clinton Administration, from 1993 until his retirement from federal service in 1996. In 2013, Young joined Braeburn Pharmaceuticals as executive vice president, clinical and regulatory affairs to contribute to the development of the
new drug application The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial ...
(NDA) to FDA for evaluation of Braeburn’s Probuphine (
buprenorphine Buprenorphine, sold under the brand name Subutex among others, is an opioid used to treat opioid use disorder, acute pain, and chronic pain. It can be used under the tongue (sublingual), in the cheek (buccal), by injection (intravenous a ...
) implant, which was approved on May 26, 2016. Probuphine is the first buprenorphine implant for the maintenance treatment of opioid dependence. Young has advised numerous pharmaceutical companies on regulatory issues and clinical development. He served as interim vice president for clinical and regulatory affairs of Bioventus Global and became an adjunct partner and partner at Essex Woodlands in 2002. He also co-founded the Cosmos Alliance and served as its chairman and chief executive officer. He served as the executive vice president of clinical and regulatory affairs at TissueTech Inc, where he was tasked to lead the company in its transition from a HCT/P regulated company into a biologics company through the pursuit of multiple NDAs for ultimate BLA approval.


Awards and achievements

Young contributed to more than 200 scientific publications in the fields of biotechnology and pathology and developed some of the earliest cloning enzymes, vectors, and vehicles. He is a member of the National Academy of Medicine. At the Department of Health and Human Services, Young received a Secretary’s Special Citation and the Inspector General’s Award for Outstanding Integrity. He also received the Surgeon General’s Exemplary Service Medal from the
United States Public Health Service The United States Public Health Service (USPHS or PHS) is a collection of agencies of the Department of Health and Human Services which manages public health, containing nine out of the department's twelve operating divisions. The assistant s ...
and the 2006 Distinguished Alumnus Award from SUNY Upstate Medical University. In 2015, Young was awarded the 2015 Distinguished Scientist Award by the
American College of Toxicology The American College of Toxicology (ACT) is a professional association that provides a forum for the exchange of scientific information in the field of applied toxicology Toxicology is a scientific discipline, overlapping with biology, chemis ...
for his outstanding contributions to toxicology and the improvement of public health.


Personal life

Young was the son of Frank E. and Erma F. Young. He served in the United States Navy in the Ready Reserve from 1956-1964 and retired in 1996 from the Commissioned Corps of the United States Public Health Service as a rear admiral after 12 years of Service. He was married to the former Leanne Hutchinson from 1956 until her death in 2008. They had five children. Young also served as a pastor in the Evangelical Presbyterian Church for approximately six years before retiring as pastor emeritus. He died of lymphoma on November 24, 2019, in
Wilmington, North Carolina Wilmington is a port city in New Hanover County, North Carolina, United States. With a population of 115,451 as of the 2020 United States census, 2020 census, it is the List of municipalities in North Carolina, eighth-most populous city in the st ...
at age 88.


References


External links

* {{DEFAULTSORT:Young, Frank E. 1931 births 2019 deaths People from Mineola, New York Military personnel from New York (state) Physicians from New York (state) Commissioners of the Food and Drug Administration State University of New York Upstate Medical University alumni Case Western Reserve University alumni University of Rochester faculty Deaths from lymphoma in the United States Deaths from cancer in North Carolina Reagan administration personnel George H. W. Bush administration personnel Members of the National Academy of Medicine