The Institute of Medicine (IOM) released a report Tuesday recommending that the U.S. Food and Drug Administration (FDA) review drugs on a regular basis for as long as they are on the market in order to catch any new safety issues. The IOM also recommended that the FDA create a comprehensive, publicly available document that reflects risks as they crop up throughout the "lifecycle" of the drug. This report is further evidence that FDA approval does not mark a drug as safe. Vioxx, Accutane, and Reglan are just a few recent ensamples of drugs that were approved by the FDA and then found to have dangerous side effects.
This report is even more troubling because, the U.S. Supreme Court ruled last June that generic drug manufacturers only have the responsibility to carry the same warning label as the brand name drug, even when they know of new risks. As a result of that decision, many people injured by generic drugs have been unable to hold generic pharmaceutical companies accountable for their injuries. This is in direct contrast to the U.S. Supreme Court’s decision in 2009, which established that people injured by brand name drugs can pursue their claims in court.
Many long term side effects of prescription drugs are not known at the time of FDA approval. In fact, the IOM report noted that “it is impossible to know all of the risks and benefits of a drug before approval.” Without accountability in the courts or from the FDA, generic manufactures have no motivation to warn the public of new side effects, leaving consumers paying the price while the drug companies continue to profit.