The FDA Approval Process

Every new drug needs proof that it is safe and effective before it is approved for public distribution. While no drug is 100 percent safe, the Food and Drug Administration (FDA) analyzes whether the pharmaceutical’s benefits outweigh its potential risks and side effects. If so, the FDA approval process will sanction that drug for marketing and distribution.

Research, Lab Tests and the Application

When a pharmaceutical company develops a drug, it must first conduct about three years of research and laboratory testing. The company submits the testing results to the FDA, which reviews the findings and determines whether the drug should move forward.

Next, the manufacturing company must submit an extensive application to the FDA, which may reach 100,000 pages.

Clinical Testing Phases

Clinical research and testing is necessary to determine a drug’s safety and effectiveness. This is divided into three phases:

  • Phase 1: This step takes about one year and involves 20 to 80 volunteers to help determine how safe the new drug is.
  • Phase 2: This step takes about two years and involves between 100 and 300 volunteers with a specific illness or condition to evaluate the drug's effectiveness.
  • Phase 3: This step involves between 1,000 and 3,000 patients in hospitals and clinics. This is the last step in determining any adverse reactions over a longer, three-year period.

The Consumer’s Role

While clinical testing takes years to complete, the long-term impacts of a new drug remain unknown. If you are the consumer of a new pharmaceutical, be sure to stay up-to-date about any reported side effects. Although one condition of FDA approval is that the drug company conducts post-marketing studies, few companies adhere to this condition.

The FDA has little enforcement power once it approves a drug, so it is up to the consumer to pay close attention to any potential side effects. In doing this, you can you can play a role in having dangerous and defective drugs recalled and removed from the marketplace before they injure consumers.

At The Cochran Firm, we have your best interests at heart. If you become injured because of a defective drug, call us first. We can help you through the claim process and get you the compensation you deserve to prevent anyone else from becoming hurt.

If you or a loved one has suffered an injury because of a defective drug or faulty medical device, please contact the experienced defective drug attorneys at The Cochran Firm. No matter where you live in the United States, we have an office near you. Please call today.