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Monday, October 28, 2013

Medication and FDA enforcement

According to a PEW Health Group report "After Heparin: Protecting consumers from substandard and counterfeit drugs",  in which experts within the FDA were interviewed, there are surprising limitations to what the FDA is capable of doing. 

As expected "the FDA has complete legal discretion" whether or not to allow a drug to be sold in the US.  But to my shock:
  "The FDA does not have the authority to order a drug recall, nor
    may it halt product distribution on it's own.
  "If the FDA finds it necessary to forcibly remove a pharmaceutical
   from the market, it must go through the courts to request a seizure,
   and a separate seizure action is needed for EACH COURT
   DISTRICT where the [drug] may be found."
             2.4.1 Limitations of current enforcement tools and authorities

I am bewildered at how big a job that must be; the US Food and Drug Administration is basically supposed to oversee the safety and legitimacy of every single piece of food, every drug and every medical device that is trying to get sold in the country.  And at best it works like a filter, secondarily like a delayed, massively inefficient enforcer.

There's 314 million of us.  We need to be our own enforcers. 

I am unabashedly extremely conservative when it comes to the use of medication.  While I do believe there might be an appropriate time and place for the use of some medication, I also feel very strongly that medication is OVERUSED to tragic effects in our country.  Assuming that any drug is safe and appropriate just because it is so universally accessible is an error of logic.

I never once had a patient who had a headache, that was caused by a deficiency of aspirin.  But I have had TWO patients die from the "normal" side effects of the drugs they were taking.

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