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How drugs become approved by the FDA

The FDA drug approval process has come a long way since it’s humble beginnings as the simple running of tests on agricultural products in the mid 19th century. Since then, American lawmakers have passed such monumental health protections as the 1906 Pure Food and Drug Act to help ensure that what we eat and what we use to treat our illnesses and ailments are as unadulterated and as properly branded as possible.

Within this watchdog agency, the Center for Drug Evaluation and Research (CDER) has as it’s main job the evaluation of new and generic pharmaceuticals before there is even the chance of marketing in the United States. The entire process of creation, testing, application, review, and approval for prescription by physicians takes on average 12 years.

After 3-4 years of testing, a drug company may elect to apply to the FDA for permission to test the compound on human subjects. Of the applications sent to the FDA for human testing approval, only one out of every thousand will statistically make the cut. If the review process works in the drug company’s favor, the drug enters “investigative” status and is tested on humans in three phases:

  • Phase I: 1 year of testing on 20-80 healthy volunteers to establish safety
  • Phase II: 2 years of testing on 100-300 healthy volunteers to determine effectiveness
  • Phase III: 3 years of testing on 1000-3000 healthy volunteers to find adverse reactions

The drug company then submits an enormous application that may consist of upwards of 100,000 pages of material to be reviewed for a period of approximately 2 to 3 years, before the drug in question finally is allowed to be prescribed by your general practitioner. It should be noted that although the drug has been approved by the FDA at this point, reports of adverse reactions and efficacy are constantly coming into the FDA as well as other watchdog agencies.

Additional tests to find other uses for a drug may also be conducted, and if a drug is deamed too dangerous for human consumption for whatever reason, a drug recall may be necessitated. In this sense, study and review of a given medication is never truly complete.