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Delay in Generics Labeling Ruling Leaves Patients at Risk
When taking any prescription drug, patients must be aware of the risks and/or potential contraindications. Consumers tend to operate under the assumption that prescription drugs are safe if approved by the FDA, but there are risks and side effects with each and every prescription drug. Some prescription drugs have very serious or even fatal consequences to consumers.
To Label Or Not To Label
For years, brand-name drug makers have been required to inform patients about the risks of taking every medication. Whenever new information becomes available about a drug, brand-name manufacturers are required to update the labels to reflect the expanded information. The same has not been true, however, of generic drug makers.
Five years ago, the Supreme Court ruled that generic drug makers could not be held responsible for failure to warn patients about the risks associated with their products. Their reasoning was that because generic companies are not allowed to independently change the labels on their products, they did not have the control to create necessary warnings.
This, however, has proven to be controversial. While patients who took brand name medications are awarded multi-million dollar settlements, patients who took the generic brand of the same drug are having their cases thrown out of court due to federal preemption.
No End In Sight
Last month, the Food and Drug Administration released a statement that the agency would not make a decision regarding the responsibility of generic drug manufacturers to make a greater effort to inform patients of drug risks until 2017. This is the third delay from the FDA since 2013. The pause is in large part due to pushback from the pharmaceutical industry and lawmakers. When asked about the delay, a spokeswoman from the FDA said that it reflects “ongoing work.”
In the meantime, patients are left in a difficult situation. Uninformed as to the risks of their drugs and unable to sue generic companies if the medication should in some way harm them, many patients will have to make some challenging decisions regarding their health in the next year.
Contact Us Today
If you have been harmed by an unsafe drug or product, you should not have to face the legal process alone. Contact our experienced Tampa medical malpractice lawyers today for a free case evaluation. We will work with you to help you get back to living your best possible life.