Before a drug can go into general distribution in the US, it must undergo a lengthy approval process through the Food and Drug Administration (FDA). This process involves several levels of testing for safety and effectiveness. Any risks are noted, and if the benefits of the drug significantly outweigh the risks, the drug is likely to be approved.

Levels of Testing
A new drug typically undergoes three years or more of testing in the laboratory before application is made to the FDA to begin the approval process. The FDA process can take as long as another eight years.

FDA testing uses three phases of clinical trials, each one involving a larger sample group to determine the drug's effectiveness:

• Phase One-20-80 healthy volunteers, process takes about one year
• Phase Two-100-300 patient volunteers, process takes about two years
• Phase Three-1000-3000 patients, process takes about three years

After this testing is complete, the company developing the drug can submit an application to the FDA for approval. This process takes another two and a half years on average. The complete cost of the approval process averages $350 million.

The FDA uses this complex process to ensure drugs work as advertised, and that drugs that go on the market are accompanied by sufficient documentation of any possible risks or precautions.

In spite of the FDA's rigorous approval process, some drugs on the market still lead to serious and even deadly side effects. If you have suffered from serious side effects due to a prescription drug, please contact a pharmaceutical injury attorney in your area for more information about possible compensation.