Dr James Schaller
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How About A New FDA Goal & Rating System?

We need to stop pretending that drug safety is entirely certain and possible, and offer graded and educational ratings of safety. Big Brother agencies are not effective at keeping the best options available, and poor medications out. So perhaps it is time for citizens to make their own educated decisions.

As a research clinician I am regularly faced with the issue of safety. I have to look at new and old medications, and what is in the USA and what is not available. Some of the world's best medications will always come here last or never.

So here are proposed ideas to allow us access to all possible data to make our own decisions as adults.

  • If a medication has been used in other countries on 50 million people, it gets an F rating for foreign data only.
  • If it has had studies done in the USA, but only on a few thousand people, it gets an A, or approval.
  • For each year it is approved it gets a number, such as A3, which means it has been available three years post USA approval.
  • For each ten million patients treated the medication gets a 10M.
  • If a medication is not FDA approved, the physician must have a patient note, or a court appointed guardian saying the patient understands that the medication is being used in an experimental manner and should be offered the option of the medication. Why should some of our useful options wait 10-20 years or never come to the USA due to the massive cost of FDA experiments for approval and the FDA barriers? A medication available in 70 countries for ten years should be able to be prescribed to those who want it in the USA. Period. Why wait for the Ivy League and Drug Company fusion to decide what you are allowed to have for treatment.
  • These are combined if applicable.

If You Have Better Ideas, Please Let the Lawyers Running all Three Branches of State and Federal Government Know.


Dr. J

Bank Towers, Tamiami Trail, Naples, FL
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