Who is Regulating Drug Safety?

The AFX News reports that between 1998 and 2005, an analysis of FDA data reveals triple the number of complications and mortality from pharmaceutical, supposedly regulated, drugs. If those statistics are accurate, dangerous side effects and deaths from medicinal drugs are out of control.

So, when the FDA “approves” a drug, it’s safe, right? Not necessarily. In fact, the FDA will, if candid, admit that they have to rely on the pharmaceutical company asking for the approval to submit complete, accurate and candid information. The FDA does try to investigate drug approvals, but they do not possess the resources to conduct independent evaluations of new drugs.

Theoretically the system should work; the drug companies and medical device manufacturers conduct the appropriate studies and clinical trials; they report the data and results honestly; the drugs are properly approved or disapproved. So, what is the problem? In a word, the problem is greed and corruption; oh, sorry, two words.

Pharmaceutical companies are fond of complaining about the “hoops” they must jump through to get a new, revolutionary”, drug approved and they resent lawsuits that call them to account for injuries or death their drugs cause. Drug and medical device companies report that costs for their products are hugely increased by the regulations and all those lawsuits.

The AFX reported that, between 1998 and 2005, serious complications had increased to 467,809 and deaths had increased from 5,519 to 15,107. The better than 15,000 who died probably would have hoped for tighter regulation and greater threats of lawsuits.

In 2005, the US pharmaceutical industry showed earnings of over $13 billion and European earnings of nearly $10 billion. I think they can afford to make sure their drugs are safe and their regulatory compliance is complete and accurate.

The fact is, some drugs are marked up as much as 21000% to as high as 500,000% over the actual cost of the ingredients. Yes, the cost of delivering drugs and complying with the “hoops” of tho regulatory agencies can be significant. When you can reap thousands of percent in profit margin, it is clearly worthwhile.

The bottom line: what is the cost of even one loss of life due to poor drug approval compliance?