Side effects of drugs may be revealed years after approval
The FDA has a difficult balance to strike between adequate testing and pressure to get new drugs on the market quickly. This pressure can come from several sources, but especially from the manufacturers who stand to reap huge profits if the medications are approved and from its often well-connected shareholders who stand to benefit from the manufacturers’ stock appreciation. As a consequence, and with limited resources, the FDA relies heavily upon information provided by the manufacturers themselves. Some FDA studies may be done with small groups, which can make it difficult to identify some side effects until the drugs are in wider usage.
In some cases, drugs prove to be dangerous enough that they are taken off the market. Even when this does not occur, if users suffer serious harm from a drug and they were not adequately informed about the risks, they might have legal rights against the manufacturer. In some cases, a manufacturer may have been aware of potential adverse effects without publicizing the information, or the drug may not have been tested thoroughly enough.
The FDA has a difficult balance to strike between adequate testing and pressure to get new drugs on the market quickly. This pressure can come from several sources, but especially from the manufacturers who stand to reap huge profits if the medications are approved and from its often well-connected shareholders who stand to benefit from the manufacturers’ stock appreciation. As a consequence, and with limited resources, the FDA relies heavily upon information provided by the manufacturers themseleves. Some FDA studies may be done with small groups, which can make it difficult to identify some side effects until the drugs are in wider usage.
In some cases, drugs prove to be dangerous enough that they are taken off the market. Even when this does not occur, if users suffer serious harm from a drug and they were not adequately informed about the risks, they might be have legal rights against the manufacturer. In some cases, a manufacturer may have been aware of potential adverse effects without publicizing the information, or the drug may not have been tested thoroughly enough.