Time vs. Safety
The time vs. safety tradeoff is a critical issue of balance that must be carefully considered. It is the important that drugs are available to the public in an acceptable period of time. However, these products must be known to endanger the people who consume them. Much of the drug development time is spent conducting animal and human trials. There is criticism, that the trials required by the FDA are too extensive and time-consuming. However, both animal and human testing is paramount to determine benefits and risks of a drug. An act was passed in 1992 , Prescription Drug User Fee Act, which required independant companies to pay the FDA for review of its drug. This money was then used to hire more employees for the FDA in the attempt to accelerate the approval process. Since this time, the average review time has decreased. Because of its documented success, the bill was renewed in 1997.
The following options have been discussed to facilitate a faster approval rate.
Require Time Limits - This requires that the FDA has a set time limit with which an application must be reviewed and a decision made. A tentative time period of four to six months has been suggested.
Permit Drugs that are or have been approved in Europe to be placed on the US market without FDA approval.
Third-party reviewing - This would be a system in which the company that developed the drug or device, would itself review the product when the FDA has insufficient manpower to conduct the review.