• Leadership and Structure
• Corporate Governance
• Public Policy
  • Access and Affordability
  • Pricing and Value
  • Health Care Reform
  • Resources
  • Pat the Pill
    • Pat Lends a Helping Hand
    • Other Ways to Save
    • How New Medicines Are Invented
    • A U.S. Patent
    • Testing for Safety and Effectiveness
    • What Are You Paying for Pat...and Why?
    • Meet Pat´s Relatives
    • Pat Earns His Keep-And Then Some
    • Introducing Pat to Doctors
    • Introducing Pat to the Public
    • Pat Grows Old and Loses His Patent
    • More Pats on the Way
• History
• Accolades

Testing for Safety and Effectiveness

Pat is first tested in the lab to see whether he might work. If these tests show promise, Pat starts "clinical trials." These are medical tests on thousands of volunteers. Pat is tested under very close medical supervision. This testing process takes many years. The testing sees if Pat improves patients' health and what kind of side effects he causes. We know that every prescription medicine can cause side effects in some people. Before the public can buy Pat, we need to be sure he can help without too many risks.

Only 1 out of 5 medicines makes it through the clinical trials. Once the medical tests are done, Pfizer and the Food and Drug Administration (FDA) review the results. For the FDA to approve a medicine, they balance the good it can do for patients against the possible risks to the patients. All 5 of the drugs we tested, not just Pat, cost millions of dollars to develop. But only one may be good enough for patients. So on average, a new drug costs more than $800 million to develop.²

Some people ask why the odds aren’t better than 1 in 5. Until a new drug is tested in people, no one knows for sure what it can do. It's a delicate balance. Testing takes time, money, and good medical judgment. In Pat's case, the test results are good. The FDA decides his benefits outweigh his risks for patients in the U.S. That whole process took about 12 years. Now, Pat is ready for your doctor to consider for you and other patients.

• Continue to What Are You Paying for Pat...and Why?

² DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: New estimates of drug development costs. J Health Econ. 2003; 22:151-185. Available at: http://www.cptech.org/ip/health/econ/dimasi2003.pdf. Accessed December 16, 2003.