New Drug Approval Process

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New Drug Approval Process

• FDA Approvals

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• It takes 12 years and over 350 million to get a
  new drug from the laboratory onto the pharmacy
  shelf.
• Once a company develops a drug, it undergoes 3 ½
  of laboratory testing,
• Then an application is made to the U.S. Food and
  Drug Administration (FDA) to begin testing the
  drug in humans.
• Only 1 in 1000 of the compounds that enter
  laboratory testing ever make it to human testing.

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• If the FDA gives the green light, the
  "investigative" drug enters three phases of
  clinical trials.

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Phase 1

• Phase 1 uses 20-80 healthy volunteers to
  establish a drug's safety and profile.
• Phase 1 lasts about 1 year 

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Phase 2

• Phase 2 employs 100-300 patient volunteers to
  assess the drug's effectiveness.
• Phase 2 lasts about 2 years

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Phase 3

• Phase 3 involves 1000-3000 patients in clinics
  and hospitals who are monitored carefully to
  determine effectiveness and identify adverse
  reactions.
• Phase 3 lasts about 3 years

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Next step

• The company then submits an application (usually
  about 100,000 pages) to the FDA for approval
• The application process can take up to 2 ½ years.
  
• After final approval, the drug becomes available
  for physicians to prescribe.
• At this stage, the drug company will continue to
  report cases of adverse reactions and other
  clinical data to the FDA.

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Money, money, money, money

• The research-based pharmaceutical industry
  currently invests 12.6 billion per year in new
  drug development.
• Historically, the drug development figure doubles
  every 5 years.

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References

• Retrieved from http//www.drugs.com/fda-approval-p
  rocess.html on 3/27/09