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FDA Drug Safety and Efficacy Spending vs. Emergency Swine Flu Funding Request

$1.5 Billion Flu Funding Request is One and a Half Times the Amount Spent Annually on FDA Drug Safety and Efficacy Testing For the Entire Drug Industry

The US drug supply is unsafe, unproven and ineffective. The reason why is clear. Simple math tells the whole story.

Pre Approval Spending

The pre-approval spending on drug safety and efficacy is grossly inadequate. It is comprised of Prescription Drug User Fee Act (PDUFA) fees paid by the drug manufacturers and US tax dollars. Total 2006 drug safety and efficacy spending was around $515 million. Of this, roughly $305 million was paid by the drug companies (PDUFA) and roughly $215 million in tax dollars. [1]

FDA requested an increase in the 2007 budget of $70.8 million. Of this, only $6.4 million was for drug safety. $30.4 million was for “Pandemic Preparedness” (read vaccine stockpiling) and $19.8 million for “Food Defense”. [2]

Drugs are brought to market without being adequately tested for safety or efficacy. There is no post-approval efficacy tracking and virtually no post approval safety tracking. As a nation, 2006 tax spending was less than $255 million annually “assuring” the safety and efficacy of drugs, which are the foundation of our nation’s $2.1 trillion (in 2006) sick-care industry.

Sticking with 2006 data, since we have a complete accounting for that year, Medical News Today reported that in 2006, drug sales reached $274 billion. [3]

This puts pre approval drug safety tax spending at less than 0.1 percent of sales and pre approval drug company contributions at less than 0.2 percent of sales for 2006 .

Post Approval Spending

Duke University released a study in 2006 that revealed that FDA annual spending on post approval drug safety monitoring was a miserly $22.1 million. Post approval safety spending by the top 20 drug companies was estimated at only about 0.3 percent of sales or $800 million. The companies claim that each spent an average of $56 million for post-approval safety, in a year during which their mean sales were $17 billion per company. [4] 

If we believe the drug company self reported estimate of $800 million spent on post approval safety and efficacy spending and add in the paltry $22 million in tax spending, about 0.5 percent of sales is spent in total on safety and efficacy for both pre and post approval combined. (While the Duke study reflects 2003 data, it is highly unlikely that the percentages have changed much, as their has been no major legislative action on the subject.)

Of every $100 drug prescription filled in 2006, only about 50 cents had been spent to make sure it was safe and effective (with roughly $13.00 spent to market this chemical to you). Looking at it another way, for every dollar generated by drug producers, ½ of one penny was spent ensuring safety and efficacy. That is all your safety is worth to the FDA and the pharmaceutical industry.

And if you think these numbers have changed radically since 2006, think again. According to the April 26, 2007 issue of the New England Journal of Medicine, "For fiscal year 2008, total user fees would be nearly $400 million, accounting for more than 40% of FDA resources for drug regulation." This puts 2008 total spending at roughly $1 billion. [5]

Here goes the 2008 math. $1 billion is spent to test, approve and regulate $291 billion in drug sales [6] for which the testing, monitoring, dispensing and third party payment of same accounts for the lion's share of an estimated $2.4 trillion in health care spending [7].

How can this possibly be sustained? The fact is, it can't.

Make an appointment today to see your chiropractor, a member of the largest group of drugless health care providers in the world, to see how they can help you to extricate yourself from the pharmaceutical fantasy that is bankrupting our country.

Reference Sites

1. See page 109 & 110 of the following:
    http://www.fda.gov/oc/oms/ofm/budget/2006/PDFs/TablesBnB.pdf

2. http://www.fda.gov/bbs/topics/news/2006/NEW01310.html

3. http://www.medicalnewstoday.com/articles/65204.php

4. http://www.dcri.duke.edu/news/Archives/2006/2006-03-09.jsp

5. http://content.nejm.org/cgi/content/full/356/17/1700

6. http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aVPMLnCf2IS8

7. http://www.nchc.org/facts/cost.shtml