From the 3/12 Show – FDA User Fees and Protecting the Fox

In 1992, Congress created the Prescription Drug User Fee Act (PDUFA).  The intent was to collect additional revenue from the drug companies (Pharma) for the FDA to obtain additional staff to help expedite the approval process for pharmaceuticals.  It can be argued on both sides as to the success or failure of PDUFA.

Most of the criticism of PDUFA is that the FDA is too highly influenced by the Pharma money being collected.  The fees collected continue to increase yearly.  The 2013 proposed fees are approaching $2 billion  This is a whopping $700 million dollars over the projected fees in 2011.

It would be naive to believe the fees do not influence the FDA policy makers.  The money has become a necessary part of the FDA life support.

The radio show’s contention is that the fees protect the fox in the henhouse after the chickens have started to die.  The information disseminated on the possible side effects and damage implicated from too many drugs is woefully lacking.

The present package inserts approved for the medical professions by the FDA minimize the negative possible outcomes from the drugs.

For example:  In Part, the warning label for OxyContin reads “Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit”.

How about changing the FDA warning to:  OxyContin (oxycodone) has been a part of tens of thousands of deaths, and millions more dependent or addicted.

For example:  In Part, the warning label for antidepressants reads “antidepressants may increase the risk of suicidal thinking and behavior in some children and adolescents”.

How about changing the warning to:  Young girl hangs herself while on an anti-depressant �

For example:  Adderall’s present warning isn’t getting the parent’s attention:  AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE.

How about changing the warning to:  “manufacture admits to 20 reported deaths by heart attack and 12 reported strokes”.

It is the radio show’s contention that education pass the control of Pharma and the drug companies would save lives, create more positive outcomes and save the taxpayers and business billions of dollars that could be used for more productive areas in our communities.

Taking the fox (Pharma) out of the henhouse (FDA) would bring more education to the ultimate consumer and I think a change in the perspective on where powerful mind altering drugs fit into our communities.

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