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Improving Public Health: Promoting Safe and
Effective Drug Use

The FDA's Center for Drug Evaluation and Research (CDER) promotes and protects the health of Americans by assuring that all prescription and over-the-counter drugs are safe and effective. CDER evaluates all new drugs before they are sold, and serves as a consumer watchdog for the more than 10,000 drugs on the market to be sure they continue to meet the highest standards. The center routinely monitors TV, radio, and print drug ads to ensure they are truthful and balanced. CDER also plays a critical role in providing health professionals and consumers information to use drugs appropriately and safely.

In 2002, the center focused on five strategic areas:

• Strong FDA
  Strong and sound science means CDER scientists stay on the cutting edge of new technologies. The center's mission depends more than ever on a solid cadre of experienced physicians, toxicologists, chemists, statisticians, mathematicians, project managers and other highly qualified and dedicated professionals.
• Efficient risk management
  In 2002, CDER evaluated many new drugs that offered important treatment options for Americans. However, it is of concern that the approval of truly new drugs is at the lowest level in a decade. The center has launched two important initiatives to remove barriers to innovation in drug development and to facilitate the modernization of American drug manufacturing.
• Patient and consumer safety
  CDER continued to enhance its drug safety program to help make sure that drugs are used safely once they're approved. The center alerted the public to the dangers of importing or buying over the Internet 10 drugs that are marketed in this country with special safety restrictions.
• Better consumer information
  CDER is collaborating with a broad spectrum of groups to improve information for prescribers and consumers. Industry and consumers are increasingly turning to the CDER Internet site for important and up-to-date information on the center's regulatory programs and on the drugs they take to improve their health.
• Counterterrorism
  CDER continues to facilitate development of new drugs and new uses for already-approved drugs that could be used as medical countermeasures.

For more information, please go to the CDER Web site at www.fda.gov/cder, or call (888) INFO-FDA (888-463-6332), and follow the prompts for human drugs.

Year 2002 Drug Approvals

In 2002, CDER approved 78 new drugs, 17 of which were never before marketed in the United States. Eleven of the new drugs received priority status in recognition of their special importance for the public health. Thirteen of the newly approved drugs were authorized for over-the-counter sale without a prescription. The center also approved 321 generic versions of already-marketed drugs. More details about CDER's accomplishments in 2002 can be found in the CDER Report to the Nation: 2002 at ww.fda.gov/cder/reports/rtn/2002/rtn2002.htm.

Publication No. FS 01-3
Revised: August 2003

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