What is the FDA Approval Process for Medications

Oct. 27, 2004

Dr. Mark Paller discussed the FDA approval process on the Oct. 27 KARE 11 Today Show. 

What is the FDA approval process for medications? Who does the safety research? What safeguards are in place to protect consumers from situations like the Vioxx recall?

Paller: The FDA approval process for drugs is a complex, multi-year system that attempts to balance the need for strong safety measures with the desire to develop new drugs to fight disease.

Researchers studying potential new drugs must apply for permission from the FDA to hold clinical trials, which provide them with information about how well the drug works and potential risks. After sufficient safety research, the FDA consults with experts to determine whether or not to approve the drug. Even after approval, the FDA can require additional testing.

The Process

1. After determining a drug is safe to administer to humans, the group that is studying the new drug seeks permission from the FDA to perform human subject research or a clinical trial. During the trial, researchers provide information about how the drug is working to the FDA.

2. When enough information is gathered about the risks and benefits of the drug, the researchers submit a New Drug Approval application to the FDA. The FDA then uses outside experts and its own staff to decide whether the drug should be approved. Only approved drugs can be sold or use for routine clinical use. The FDA can still require additional studies after a drug is approved—this is called post-marketing surveillance.

3. The FDA’s extensive testing process is the main safeguard for consumers. Safety research includes database and literature searches, animal studies and clinical trials. All safety problems cannot be anticipated before approval. Situations like the Vioxx recall are complex, because the public demands faster access to new drugs, while expecting the drugs to be perfect.

For more information, contact the U.S. Food and Drug Administration