The Heparin Debacle Part Three - The FDA Falls Flat

Linda Snyder

Contributor

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 “Protecting and Promoting Your Health.” That’s the tag line posted on the U.S. Food and Drug Administration web site. Protecting and promoting your health, doesn’t seem to have the same meaning to the FDA as it does to the U.S. consumer.

Putting it very simplistically, the FDA is charged with ensuring that the food and drugs we consume are safe before they are made available to the public. Recent news has shown that many of the drugs that the FDA has approved have not only not failed to "protect and promote our health," but in fact have deadly consequences.

Consider these facts:

•     • FDA approved drugs, Oxycodone, Fentanyl and Clozapine, are on the list of top 10 deadliest drugs and are responsible for over 12,000 deaths from 1998 to 2005.
•     • The American College of Cardiology has recommended that the popular FDA approved drugs, Vytorin and Zetia should only be used after all other cholesterol lowering drugs fail.
•     • A recently published article in the Journal American Medical Association (JAMA) claims the drug maker Merck drafted many of the research studies for their best selling FDA approved drug Vioxx, then had prestigious doctors put their names on the reports prior to publication.

According to a report from the Government Accountability Office, the FDA would need to spend at least an additional $56 million next year in order to fully inspect foreign plants. The FDA would need at least $15 million a year to inspect Chinese drug plants every two years to comply with US standards.

At its present pace, it would take the FDA nearly 27 years to inspect every foreign manufacturer that exports medical devices to the US. It would take 13 years to inspect every foreign drug plant and 1,900 years to inspect every foreign food plant.

Although the Bush administration acknowledges the problem, President Bush’s budget does not provide the FDA with the funds to hire additional inspectors. There are proposals in motion to increase the FDA’s budget and to shift some of the financial burden onto the domestic and foreign manufacturers to pay fees for inspections.

I don’t know about you, but now when I go to my medicine cabinet and take out that bottle of FDA approved prescription medication that I assumed was safe, because the FDA’s motto is “Protecting and Promoting Your Health”, I get a funny feeling in the pit of my stomach that no medication can fix.