The Pharmaceutical Approval Process
The FDA involvement starts at the beginning of drug development. Before a new drug ever enters a human body, it must be tested thoroughly in animal toxicity trials. These studies allow developers to see what dosages and areas of safety need observation during human studies and ensure that the drug is safe for human consumption. After animal testing, drugs move under an investigational new drug (IND) application period.
During the IND application period, drugs undergo three-phase clinical human trials.
Phase I trials assesses most common side effects and the occurrence of side effects. Drugs are given to the target treatment group and to healthy individuals who are tested for metabolic and cardiac effects, as well as, interaction with other drugs.
Phase II trials are the earliest tests to determine the drug's effectiveness for treating the intended disease or illness it's created for. These trials involved hundreds of subjects and are closely observed for side effects and its effect on the disease or illness. Some subjects take a placebo and some do not at this phase.
At Phase III, the drug is administrated to a large group for over six months, so the long term effects can be studied. Phase III allows all data extrapolation for the general population. This is the phase where the labeling information regarding side effects, dosage, and treatment come from.
After successful trials a drug is approved. The FDA also conducts post-approval assessments of all approved drugs. Serious and unidentified risks are submitted to the FDA immediately and less urgent safety issues are given in periodic reports. Sometimes the FDA requires changes to information on certain drugs at this point.
Regardless of the FDA's efforts, drugs do come on the market and sometimes an issue arises afterward. In many instances, the FDA requires manufacturers to change warning information on certain drugs. A black box warning indicates that a drug has been linked to serious side effects and should be used with caution. In rare cases, the FDA will recall a drug for safety and further research. Many times drug formulas can be changed to eliminate some of the side effects.
Pharmaceutical Liability Explained
Drug manufacturers sometimes face liability suits when drugs and devices cause injury or illness. Companies may also beiable when patients are not warned of potential risk.In cases relating to defective devices patients may complain that manufacturers did not research properly and were not able to warn of early failure.