DONATE!
PLEASE SIGN!
“No one can make you feel inferior without your consent”
Eleanor Roosevelt 1884-
JOIN US!
FDA - OVERVIEW:
The FDA does NOT test drugs; for the most part, it's role is to provide safety guidelines for testing new drugs and then to review the data resulting from such testing in order to determine if the drug/biologic meets the FDA's "risk vs. benefit" criteria.
It does this through advisory committees set up under various categories of public health and are comprised mostly of independent experts and other interested persons.
The role of the advisory committee is to make RECOMMENDATIONS to the FDA. Only the FDA can APPROVE or DENY new drug applications.
Finally, it is the FDA's responsibility to assure that the public is adequately informed of the risk/benefit of approved drugs which it does through oversight of product labelling and package inserts as well as communication to prescribing physicians and the public when a health risk is identified through wider or longer term exposure.
AREAS OF CONCERN IN THE
CURRENT SYSTEM:
Foxes in the hen house?
According to the FDA's web page on advisory committee charters, committee memberships are normally 4 year terms.
Due to the relatively small size of core members (usually around 12), it is not uncommon for the FDA to invite others to bring additional perspective to the new product review process.
Provisions are in place to exclude a committee member (or guest) from voting on an issue if there is a perceived conflict of interest (either for or against a product). However, mismanagement or lack of oversight of advisory committee member/attendee rosters could greatly undermine objectivity in evaluations either for or against a product, a manufacturer or a general treatment methodology.
Integrity of data
Recent problems with serious, even deadly, side effects of licensed pharmaceuticals have uncovered flaws in the reporting of long standing adverse effects of certain products. There will always be the temptation to highlight potential benefits while downplaying or even failing to report risk factors when a manufacturer is hoping to recoup millions of dollars spent on the development of a new product.
The "race" for a cure
There is also huge pressure to "get there first", meaning to bring a new product to the marketplace in order to block competitors who are also desperate to increase or maintain their market share.
The pharmaceutical industry is HUGE and it would be naive to forget that a corporation's first priority is its own fiscal health.
Regulated vs. Non-
The FDA seemingly ignores many unlicensed and / or non-
WHAT THE FDA SAYS:
Following are quotes from the FDA and the website links from which they were taken:
fda.gov/opacom/morechoices/mission
"FDA's Mission Statement
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
The FDA is also responsible for advancing the public health by helping to speed innovations
that make medicines and foods more effective, safer, and more affordable; and helping
the public get the accurate, science-
fda.gov/cder/regulatory/applications/
"Introduction
The Center for Drug Evaluation and Research's (CDER) job is to ensure that drugs are safe and effective. (See "Benefit vs. Risk: How FDA Approves New Drugs"). CDER does not test drugs, although the Center's Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness.
"CDER is the largest of FDA's five centers, with a staff of about 1,800. It has responsibility
for both prescription and over-
"It is the responsibility of the company seeking to market a drug to test it and
submit evidence that it is safe and effective. (See "Testing Drugs in People" in
the July-
A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the sponsor's new drug application (NDA) containing the data and proposed labeling.
"For more information on drug development, drug review, and postmarketing activities please see these resources:
"The FDA's Drug Review Process: Ensuring Drugs are Safe and Effective. (7/2002). FDA Consumer magazine article.
"From Test Tube to Patient: Improving Health Through Human Drugs (2006). In-
fda.gov/fdac/special/testtubetopatient
"New Drug Development in the United States. Online seminar provides healthcare professionals with an overview of FDA's role in the new drug development process."
Continued next page
