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U.S. FDA Law 2017-08-23T20:00:25+00:00

The U.S. FDA Drug Approval Process

What is a drug?

According to the U.S. FDA (Food and Drug Administration), a drug is defined as follows:

“A drug is any product that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; and that is intended to affect the structure or any function of the body.” 1, 2, 3, 4, 10

 The drug approval process is a lengthy and expensive one, as even the FDA acknowledges. According to their website:

“The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. … Most drugs that undergo preclinical (animal) testing never even make it to human testing and review by the FDA. The drugs that do must undergo the agency’s rigorous evaluation process, which scrutinizes everything about the drug — from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured.” 5

In addition to taking 10 to 20 years before reaching the approval stage — if the approval stage is reached at all, and not counting the preliminary years spent in drug discovery and development — the average FDA drug approval process costs between $4 billion and $11 billion, or more, according to a 2012 Forbes study.6  Figures adjusted to today’s prices would be higher.

According to the Forbes study, one example is the multinational pharmaceutical company AstraZeneca, which “spent $12 billion in research money for every new drug approved, as much as the top-selling medicine ever generated in annual sales.”7  A single clinical trial can cost as much as $100 million, averaging tens of thousands of dollars per patient per year.8

It should not be surprising, therefore, that most drugs in the FDA’s approval process never achieve approval. Less than 12% of all drugs that enter the FDA approval process actually get approved.9

The following timeline illustrates, in a simplified manner, the stages of screening through which a new drug must pass before receiving FDA approval.

 

This two-page infographic from the FDA’s website explains the stages in further detail.10

 

 

 

References

1/ https://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/UCM394845.pdf

2/ https://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm

3/ https://www.fda.gov/drugs/resourcesforyou/healthprofessionals/ucm553116.htm

4/ https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm553114.htm

5/ https://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm

6/ From a 2012 Forbes study, conducted by Matthew Harper and Scott DeCarlo of Forbes, using research by Bernard Munos of the InnoThink Center for Research In Biomedical Innovation, and based upon data going back to 1997 in a Thomson Reuters database using FactSet. Reports from Tufts University citing $3 Billion or less per drug for FDA approval were found to have been inaccurate, with the true figures being 3 to 4 times as high. https://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/#648b8d2e4a94

7/ Ibid.

8/ Ibid.

9/ http://phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf, p. 1.

10/ https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm295473.htm