Sunday, March 22, 2015

U.S. FDA's Drug Approval Process is Long, Expensive, and often Political

  • Phase I
Patients: 20 - 100 healthy volunteers
Length of Study: On average 1 year.
Purpose: Safety and Dosage.
Percentage of Drugs that make it to Phase II: 70%

  • Phase II
Patients: Up to several hundred with the disease.
Length of Study: 1 - 2 years.
Purpose: Efficacy and Safety (monitoring side-effects).
Percentage of Drugs allowed to proceed to Phase III: 33%

  • Phase III
Patients: 300 - 3,000 volunteers with the disease.
Length of Study: 1 - 4 years.
Purpose: Efficacy and verifying any adverse reactions.
Percentage of Drugs that win FDA approval: 25% - 30%

The above 3 Phases do not include the Discovery and Pre-Clinical processes every co must complete before meeting with the FDA for a Phase I trial.

It requires a very long length of time to get 1 drug approved and the average cost from beginning to end is between $1.5B - $2.5B.

And then unethical examples of mega-cap Pharmaceutical cos stymieing more effective drugs to treat and even cure specific diseases by buying out a company and simply halting the trials or designing the studies to fail the FDA's approval vote.