Safety Monitoring
No prescription medication is absolutely safe and all pose some magnitude of safety and health risks. However, the U.S. drug approval process, overseen by the Food and Drug Administration (FDA), is designed to evaluate benefits and identify risks to assure that medications have an acceptable safety profile when used for their intended purpose.
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Years of Testing
To reach the pharmacy shelf, a medicine must first undergo years of scientific tests to determine whether or not it is safe and effective in treating a particular disorder. These tests are part of an extensive, complex drug development and review process that involves teams of scientists, physicians, biologists, chemists, and pharmacologists.
To reach the pharmacy shelf, a medicine must first undergo years of scientific tests to determine whether or not it is safe and effective in treating a particular disorder. These tests are part of an extensive, complex drug development and review process that involves teams of scientists, physicians, biologists, chemists, and pharmacologists.
Pharmaceutical research companies conduct these tests under the watchful eye of the FDA, which regulates the pharmaceutical industry. As the FDA evaluates a drug for safety and effectiveness, it must balance the need to get new medicines to patients as quickly as possible with the time it takes to understand the drug’s risks and benefits.
The Prescription Drug User Fee Act
In 1992, Congress passed a law to increase the FDA’s resources and expedite the drug review process. The Prescription Drug User Free Act (PDUFA) imposes fees on pharmaceutical companies for every new drug application they submit. Since PDUFA was enacted, FDA has assessed pharmaceutical companies nearly $1.7 billion in fees, significantly reducing the taxpayer burden as a result. These fees have made it possible for the FDA to hire hundreds of new physicians and scientists for its drug evaluation department, and decrease the amount of time needed to evaluate a new medicine.
In 1992, Congress passed a law to increase the FDA’s resources and expedite the drug review process. The Prescription Drug User Free Act (PDUFA) imposes fees on pharmaceutical companies for every new drug application they submit. Since PDUFA was enacted, FDA has assessed pharmaceutical companies nearly $1.7 billion in fees, significantly reducing the taxpayer burden as a result. These fees have made it possible for the FDA to hire hundreds of new physicians and scientists for its drug evaluation department, and decrease the amount of time needed to evaluate a new medicine.
Since PDUFA went into effect over 14 years ago, more than 1,000 new medicines have been made available to patients, including:
- 76 new medicines to treat cancer
- 80 medicines for cardiovascular and renal diseases
- 111 drugs for diabetes and other endocrine and metabolic disorders
- 115 medicines for neurologic and psychiatric disorders
- 178 anti-infective medicines.1
1http://www.fda.gov/fdac/features/2002/402_drug.html
Safety Monitoring Continues in Post-marketing Stage
The safety monitoring continues for these medicines long after FDA approval has been granted. Manufacturers are required to notify FDA immediately of any potential issues or concerns about a particular medicine. They also must submit summary reports to the FDA every three months on any ‘adverse events’ associated with a medicine. These quarterly reports are required for three years following approval, followed by annual reports for as long as the drug is available to patients. Serious and unexpected adverse events must be reported to the agency within 15 days.
The safety monitoring continues for these medicines long after FDA approval has been granted. Manufacturers are required to notify FDA immediately of any potential issues or concerns about a particular medicine. They also must submit summary reports to the FDA every three months on any ‘adverse events’ associated with a medicine. These quarterly reports are required for three years following approval, followed by annual reports for as long as the drug is available to patients. Serious and unexpected adverse events must be reported to the agency within 15 days.
Sometimes, the FDA requires a manufacturer to conduct additional studies. Known as Phase IV or ‘post-marketing’ studies, they evaluate long-term safety or generate more data about how the medicine affects a particular group of patients, such as children or the elderly. Phase IV studies can continue for years and involve thousands of patients.