How good is the U.S. prescription drug safety record?

Advertisement
Advertisement
Although there is always room for improvement in patient safety, the United States has the world's best drug safety record.
The FDA conducts rigorous reviews of each drug during an approval process that spans 10 to 15 years. FDA regulators thoroughly examine tens of thousands of pages of scientific data on each drug, and carefully weigh the benefits and risks of each medicine.
The FDA devotes fully half of its pharmaceutical review budget to safety issues.
User fees have made it possible for the FDA to hire additional staff to help bring drugs to the market faster by reducing review times for applications from approximately 30 months in 1992 to approximately 13 months today, while maintaining the same high standards for safety and effectiveness.
For every 5,000 compounds that could become drugs, only five ever make it to a Phase III clinical study on patients, and only one is ever approved for sale.
New ways to improve drug safety are constantly being assessed and the FDA's proposal to Congress for reauthorizing the Prescription Drug User Fee Act includes funding proposals to bring the agency's drug safety system into the 21st Century. The FDA would receive additional safety officers, new information management systems and improved access to drug safety data bases under the proposal.

Continue Learning about Drug Safety

Drug Safety

Drug Safety

Prescription and OTC drugs marketed in the United States go through a review and testing process by the Food and Drug Administration (FDA). Dosage, side effects, manufacturing and safety are evaluated through this process. Familia...

rize yourself with drug warnings, drug label changes and any drug shortages, so you can protect and maintain your health.
More

Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.