Research and Testing

• The drug development process is a lengthy one that can take up to 12 years to complete. Pre-clinical studies are performed at the start of the process, both in vitro (not on a living organism) and on animal subjects. The purpose of these studies is to identify a viable compound that can treat a known condition, or provide a preventative solution. Once the pre-clinical studies are completed, clinical trials are conducted in four separate phases using human test subjects.
  
  Phase I testing is designed to assess the safety of the compound, approximate tolerable dosage amounts and determine possible side effect triggers. Phase II testing is done to see how effective the drug is at treating a condition, and further assess safety measures. Phase III testing is done to determine how effective the compound is as compared to current drugs on the market. Once Phase III is successfully completed, the drug is considered a "marketable" product. Phase IV trials are known as the post marketing surveillance trial, and is typically handled by the agency that actually approves the product for market use.
  
  

Approval Process

• 
  
  The U.S. Food & Drug Administration (FDA) is the agency which handles the approval process for new drugs. This is a costly process with application fees ranging anywhere from $500,000 to $1 million, depending on what procedures are needed to carry out the testing process. The likelihood that a new drug will meet the agency's approval standards is slim, as only one out of every 5,000 new applications actually makes it through the approval process.
  
  Post marketing surveillance trials are conducted by the FDA for the purpose of surveying the overall safety of the drug within the marketplace. These involve clinical trials on human subjects to further identify any long-term adverse effects of the drug over long periods of time. If adverse effects occur during these trials, the drug may be pulled off the market, or restricted for certain uses. In some cases, the company sponsoring the drug may carry out their own post marketing surveillance trials in order to identify new uses for the drug.
  
  

Production Process

• The production process for a newly developed drug is carefully monitored by the FDA once it has been approved for the market. The manufacturing facility is inspected to ensure that the equipment and technology needed to produce the drug are available. A set of regulations known as the Current Good Manufacturing Practice (CGMP) are the compliance guidelines for the drug manufacturing process. If a facility violates these guidelines, or fails to meet certain requirements, the drug may be removed from the marketplace.
  
  Drug sponsors take manufacturing costs into account when a drug is under development. Production methods are determined based on cost effectiveness, and include the cost required to deliver the product to market. In accordance with FDA guidelines, manufacturers must also meet strict packaging requirements as defined by the Federal Food, Drug and Cosmetic Act of 1938. This legislation was put in place to prevent unauthorized manufacturing and distribution of licensed prescription drugs.