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EMR >> Organizations
FDA - Food and Drug Administration
Electronic Medical Records
FDA
The Food and Drug Administration
(FDA) of the United States is the government agency
responsible for regulating food (human and animal), dietary
supplements, drugs (human and animal), cosmetics, medical
devices (human and animal), biologics, and blood products in
the United States.
Description:
The FDA is a division of the Department of Health and Human
Services (DHHS), which itself is part of the Executive
Office of the President of the United States. The FDA is
divided into five major Centers: the Center for Biologics
Evaluation and Research (CBER), the Center for Devices and
Radiological Health (CDRH), the Center for Drug Evaluation
and Research (CDER), the Center for Food Safety and Applied
Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM).
Each center has its own origins and history, the oldest
being the Center for Biologics, which oversees blood
products, vaccines and newer therapeutics related to stem
cells and gene therapy. The Center for Drugs, the center
that receives the most public scrutiny, regulates
pharmaceutical medicines.
Today, the FDA is headed by acting Commissioner, Dr. Andrew
von Eschenbach, who succeeds Dr. Lester Crawford who
resigned on September 23, 2005 only two months after his
final Senate confirmation.
The over-arching mandate of the FDA is to regulate the
multitude of medicinal products in a manner that ensures the
safety of the American public and the efficacy claims
(label) of marketed drugs. The FDA's budget for approving,
labeling, and monitoring drugs is roughly $290 million per
year. "Review teams" employ around 1,300 employees to
approve new drugs. The "safety team" has 72 employees to
determine whether new drugs are hurting people. The safety
team monitors the effects of more than 3,000 prescription
drugs on 200 million people with a budget of about $15
million a year. The FDA requires clinical testing in
populations of about 3,000 people.
One aspect of its jurisdiction over food is regulation of
the content of health claims on food labels. However,
because regulating the content of labels implicates the
First Amendment, FDA must balance concerns about the public
health with the right to free speech. Dan Troy, a lawyer who
was Chief Counsel of the Food and Drug Division from August
2001 to November 2004, raised the agency's focus on First
Amendment issues.
The FDA does not pre-approve dietary supplements on their
safety and efficacy, unlike drugs. In contrast, the FDA can
only go after dietary supplement manufacturers after they
have put unsafe products on the market. However, certain
foods (such as infant formula and medical foods) are deemed
special nutritionals because they are consumed by highly
vulnerable populations and are thus regulated more strictly
than the majority of dietary supplements.
According to the Small Business Guide to FDA, "Anyone may
request or petition FDA to change or create an Agency policy
or regulation under 21 CFR Part 10.30." This is called a
Citizen's Petition and it is one method used to challenge
specific approvals by the FDA.
Critism:
The FDA has come under much criticism from many groups,
including the Government Accountability Office. FDA
regulations are blamed for causing high drug prices, keeping
life-saving drugs off the market, prohibiting access to
emergency contraceptives, censoring information about
nutritional supplements. Some propose that the FDA be
relegated to a voluntary inspection agency in order to
remedy these problems.
Regarding Blood Donation
In the past, it was the practice in America and other
countries to separate blood donations on the basis of race,
ethnicity, or religion, or to exclude certain groups from
the donor pool on those bases. Currently, in the US, these
practices have been eliminated, although American Red Cross
and Food & Drug Administration policies prohibit accepting
blood donations from gay men, specifically from any "male
who has had sex with another male since 1977, even once," or
from IV drug users or recent immigrants from certain nations
with high rates of HIV infection. While the inclusion of gay
men on the prohibited list has created some controversy, the
FDA & Red Cross cite the public policy need to protect the
blood supply from HIV & similar diseases as justification
for the ban.
Source: Wikipedia contributors (2006). Food and Drug
Administration. Wikipedia, The Free Encyclopedia. Retrieved
22:31, January 15, 2006 from http://en.wikipedia.org/w/index.php?title=Food_and_Drug_Administration&oldid=35108546.
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