Please update your browser

You're using a version of Internet Explorer that isn't supported by Questia.
To get a better experience, go to one of these sites and get the latest
version of your preferred browser:

The FDA: Neither Safe nor Effective: The Dictates of the FDA Are So Ingrained in Society That We Seldom Question Whether They Save Lives. in Actuality, Studies Show That FDA Rules Lead to Increased Deaths

By Tennant, Michael | The New American, September 27, 2010 | Go to article overview

The FDA: Neither Safe nor Effective: The Dictates of the FDA Are So Ingrained in Society That We Seldom Question Whether They Save Lives. in Actuality, Studies Show That FDA Rules Lead to Increased Deaths


Tennant, Michael, The New American


Once upon a time, so the story goes, the American pharmaceutical industry was a "wild West" in which greedy, unscrupulous snake-oil salesmen preyed on unsuspecting citizens. Average Americans, in the same tale, were incapable of sifting through the claims of drug purveyors and of determining which drugs were both safe and effective, and thus were suffering and dying in droves at the hands of these conniving profiteers. The happy ending to the story is that the federal government, in response to public outcries for salvation, stepped in and forced all drug manufacturers to prove their products were safe and effective before they could sell them; henceforth, Americans could be certain that no drugs would ever harm them again.

[ILLUSTRATION OMITTED]

Would that it were so simple. In fact, say economists Daniel B. Klein, Ph.D., and Alexander Tabarrok, Ph.D., not only is the back story in that familiar yarn sorely lacking an historical basis, but the very idea that federal premarket approval of drugs is beneficial is also greatly in doubt.

Klein and Tabarrok are the authors of an Independent Institute project called FDAReview.org that examines the question "Is the FDA safe and effective?" The two men conclude that it is neither, writing that "FDA control over drugs and devices has large and often overlooked costs that almost certainly exceed the benefits" and that "FDA regulation of the medical industry has suppressed and delayed new drugs and devices, and has increased costs, with a net result of morbidity and mortality."

They do not, however, place the majority of the blame on the FDA itself but rather on the legislation that created the FDA and has steadily expanded its duties and powers. The FDA's initial responsibilities were small and relatively innocuous; as Congress has piled more mandates onto the agency, its delays have increased and its effectiveness has decreased.

The Evolution of Regulation

Klein and Tabarrok begin their study with a detailed overview of the history of federal drug regulation. They write that "before the twentieth century there was no direct federal regulation of drugs or other consumer products," yet somehow Americans managed to survive and prosper just the same.

While it's true that the pharmaceutical industry was also relatively small prior to 1900, with most drugs being mixed by hand at local pharmacies, pharmacists and doctors had already undertaken to improve the safety and quality of the drugs being sold to consumers. For example, in 1820 the U.S. Pharmacopoeia was created. "A private, voluntary undertaking of physicians, pharmacists and colleges of pharmacy, the USP presented a formulary of compositions and listed chemical compounds, crude drugs, fixed oils, and other substances typically kept by a pharmacist," explain the authors. "Later the USP listed tests for determining purity. Leading pharmacists regularly revised the USP as new and better drugs, compositions, and tests were discovered and created." The American Medical Association and the American Pharmaceutical Association were formed; the latter began publishing the National Formulary, whose function is "to provide standards for drugs omitted from the USP and to serve as a proving ground for drugs eventually transferred to the USP," in 1888. In short, long before the FDA was even a gleam in Uncle Sam's eye, the pharmaceutical industry was regulating itself.

[ILLUSTRATION OMITTED]

Klein and Tabarrok point out that crises have played a large part in Washington's increasing control over the pharmaceutical industry. The very first significant federal drug regulation, the Biologics Act of 1902, was passed in the wake of a vaccine contamination scare. The act, write the economists, "required that federal government grant premarket approval for every biological drug and for the process and facility producing such drugs. Never before had such premarket control existed in the United States.

The rest of this article is only available to active members of Questia

Sign up now for a free, 1-day trial and receive full access to:

  • Questia's entire collection
  • Automatic bibliography creation
  • More helpful research tools like notes, citations, and highlights
  • Ad-free environment

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Project items

Items saved from this article

This article has been saved
Highlights (0)
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

Citations (0)
Some of your citations are legacy items.

Any citation created before July 30, 2012 will labeled as a “Cited page.” New citations will be saved as cited passages, pages or articles.

We also added the ability to view new citations from your projects or the book or article where you created them.

Notes (0)
Bookmarks (0)

You have no saved items from this article

Project items include:
  • Saved book/article
  • Highlights
  • Quotes/citations
  • Notes
  • Bookmarks
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

1

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited article

The FDA: Neither Safe nor Effective: The Dictates of the FDA Are So Ingrained in Society That We Seldom Question Whether They Save Lives. in Actuality, Studies Show That FDA Rules Lead to Increased Deaths
Settings

Settings

Typeface
Text size Smaller Larger
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Full screen

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited passage

Welcome to the new Questia Reader

The Questia Reader has been updated to provide you with an even better online reading experience.  It is now 100% Responsive, which means you can read our books and articles on any sized device you wish.  All of your favorite tools like notes, highlights, and citations are still here, but the way you select text has been updated to be easier to use, especially on touchscreen devices.  Here's how:

1. Click or tap the first word you want to select.
2. Click or tap the last word you want to select.

OK, got it!

Thanks for trying Questia!

Please continue trying out our research tools, but please note, full functionality is available only to our active members.

Your work will be lost once you leave this Web page.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.