Key Facts
U.S. Prescription Drug Safety: The Best in the World
- Although there is always room for improvement in patient safety, the United States has the world's best drug safety record.
- As a result of the combined efforts of the U.S. Food and Drug Administration (FDA) and America's pharmaceutical research companies, only about three percent of medicines have been withdrawn from the American market for safety reasons over more than 20 years.
- 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 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.
- America's pharmaceutical research companies are constantly striving to improve drug safety as they introduce new life-enhancing and life-saving medicines.
- Today, we support a number of recommendations for improving post-market surveillance of drugs, including more efficient use of the adverse reaction reporting system in the U.S. and maximizing use of large patient health care databases to assess drug safety and efficacy.
